Inlägget AnaCardio announces issuance of U.S. patent for AC01, strengthening protection into the 2040s dök först upp på AnaCardio.
]]>The patent covers the use of AC01 for the treatment of heart failure with reduced ejection fraction (HFrEF). The patent is co-owned by AnaCardio AB and Helsinn Healthcare SA and provides protection in the United States until June 2, 2042, plus potential patent term extensions.
Patrik Strömberg, AnaCardio CEO, commented: “This newly issued U.S. patent significantly strengthens the intellectual property protection for AC01 and reinforces the long-term exclusivity we have built around our lead candidate in the world’s largest pharmaceutical market. Together with our broader patent portfolio, it creates a strong and layered IP position supporting AC01 well into the 2040s. We believe AC01 has the potential to become a truly transformative therapy for patients with heart failure and reduced ejection fraction, addressing one of the most significant unmet medical needs in cardiovascular medicine” .
Riccardo Braglia, Helsinn Group CEO, commented: “We are very pleased with the issuance of this U.S. patent, which significantly strengthens the long-term potential of the AC01 program. This milestone further reinforces the value of our partnership with AnaCardio and underlines our commitment to supporting innovative therapies that address major unmet needs in cardiovascular disease.”
About AnaCardio
AnaCardio AB is a privately held clinical stage biopharmaceutical company developing novel drugs to treat heart failure. AnaCardio was founded based on ground-breaking research from Karolinska Institutet showing improved contractility of the heart muscle through a unique and differentiated mechanism. The Company’s lead program AC01, a first-in-class calcium sensitizing inotrope, is an oral ghrelin mimetic small-molecule, which was in-licensed from Helsinn and is now being developed as a contractile agent in heart failure patients. AnaCardio recently completed a succesful Phase 1b/2a trial with AC01 that generated proof-of-concept in patients with HFrEF, thus supporting further development of this promising oral, first-in-class drug candidate in patients with advanced heart failure.
Find more information about AnaCardio at www.anacardio.com and follow us on LinkedIn.
About Helsinn
Helsinn is a global pharmaceutical company that builds, manufactures, launches, and commercializes products to improve the quality of life for patients with cancer and chronic diseases, with a focus on supportive care, oncology and dermato-oncology. Headquartered in Lugano, Switzerland, Helsinn has direct commercial operations in the U.S., manufacturing operations in Ireland, offices in China, and a network of trusted partners enabling a commercial presence in 90 countries.
Established in 1976, Helsinn is a third-generation family-owned company with broad pharmaceutical and technical expertise. For half a century, Helsinn has been operating with integrity, passion, and quality. The company continuously fosters innovation for its patients and embraces sustainable growth as a core element of its strategic vision.
To learn more about Helsinn, please visit www.helsinn.com or follow us on on LinkedIn and X.
AnaCardio Media contact:
Patrik Strömberg, CEO
Tel: +46 704 156 159
E-mail: [email protected]
Helsinn Media contact:
Sabrina Perucchi
Group Communication Manager
Lugano, Switzerland
Tel: +41 91 985 21 21
E-mail: [email protected]
Inlägget AnaCardio announces issuance of U.S. patent for AC01, strengthening protection into the 2040s dök först upp på AnaCardio.
]]>Inlägget AnaCardio Reports Strong Phase 2a Topline Results for AC01 in patients with heart failure and reduced ejection fraction (HFrEF); Paving the Way for Rapid Advancement to Phase 2b dök först upp på AnaCardio.
]]>The Phase 2a part of GOAL-HF1 was designed in collaboration with a panel of leading heart failure experts and enrolled 26 patients across 13 European heart failure centers, randomized to receive 1 mg or 3 mg AC01, or placebo twice daily for 28 days.
Key findings
Patrik Strömberg, CEO of AnaCardio, commented: “These Phase 2a results strengthen our conviction in AC01’s potential to transform the treatment landscape for heart failure. The consistency across safety, tolerability, and markers of cardiac function improvements gives us strong confidence to rapidly progress AC01 into late-stage development. We believe AC01 is emerging as a highly differentiated, first-in-class therapy with the potential to deliver meaningful improvements in cardiac function for patients who need better treatment options.”
Lars Lund, Founder of AnaCardio and Professor at Karolinska Institutet, added: “The consistency we now observe from preclinical studies through Phase 1b and into Phase 2a strengthens our belief that AC01 has the potential to become a transformative therapy for HFrEF and to address one of the highest unmet medical needs in cardiovascular medicine. This alignment across stages of development is compelling and reinforces our commitment to advancing AC01 with confidence into the next phase of clinical development.”
Riccardo Braglia, Executive Chairman of Helsinn, added: “We are extremely pleased to see AC01, which is exclusively licensed from Helsinn, deliver such compelling clinical signals. These results reinforce the strength of the underlying science and validate our decision to partner with AnaCardio on its continued development. Their focused execution and clinical expertise are clearly accelerating the program’s progress. We believe AC01 has the potential to redefine how contractility is safely enhanced in heart failure, and we are excited to see the strong momentum AnaCardio is building.”
Rationale for continued development
AnaCardio is developing AC01 as the first oral contractile agent designed to improve cardiac output without the safety concerns associated with conventional inotropes. AC01’s mode of action — calcium sensitization through ghrelin receptor agonism — aims to increase cardiac contractility while minimizing arrhythmic and ischemic risks.
Results from Phase 1b and now Phase 2a together highlight:
These findings support AC01 as a high-potential, unique therapeutic candidate that could address a major unmet need in chronic HFrEF.
Next steps — advancing to Phase 2b
The Phase 2a results provide a unified dataset across safety, pharmacokinetics, biomarkers, and exploratory functional outcomes. Based on these findings, AnaCardio will advance AC01 into Phase 2b, a larger and longer-term clinical study designed to more rigorously evaluate efficacy and patient benefit. Preparations are underway and the company anticipates initiating the study mid-2026. AnaCardio believes AC01 is emerging as a highly promising first-in-class therapeutic candidate with the potential to significantly improve the treatment landscape for heart failure.
With promising Phase 2a results and a clear path forward, AnaCardio is entering its next stage of clinical development with strong momentum and growing confidence in AC01’s transformative potential.
About the GOAL-HF1 HFrEF study
GOAL-HF1 is a Phase 1b/2a multicenter, randomized, double-blind, placebo-controlled study evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of AC01 in patients with heart failure and reduced ejection fraction (HFrEF). All patients had NYHA class II-III heart failure with reduced ejection fraction, an ICD for primary prevention and optimized guideline-directed medical therapy.
More information about the study is available at www.clinicaltrials.gov (NCT05642507).
About AnaCardio
AnaCardio AB is a privately held clinical stage biopharmaceutical company developing novel drugs to treat heart failure. AnaCardio was founded based on ground-breaking research from Karolinska Institutet showing improved contractility of the heart muscle through a unique and differentiated mechanism. The Company’s lead program AC01, a first-in-class calcium sensitizing inotrope, is an oral ghrelin mimetic small-molecule, which was in-licensed from Helsinn and is now being developed as a contractile agent in heart failure patients. AnaCardio holds the exclusive global rights from Helsinn to clinically develop AC01 for heart failure. The company has raised over USD 40 million to date. AnaCardio is based in Stockholm, Sweden.
Find more information about AnaCardio at www.anacardio.com and follow us on LinkedIn.
About Helsinn
Helsinn is a global pharmaceutical company that builds, manufactures, launches, and commercializes products to improve the quality of life for patients with cancer and chronic diseases, with a focus on supportive care, oncology and dermato-oncology. Headquartered in Lugano, Switzerland, Helsinn has direct commercial operations in the U.S., manufacturing operations in Ireland, offices in China and a network of trusted partners enabling a commercial presence in 90 countries.
Established in 1976, Helsinn is a third-generation family-owned company with broad pharmaceutical and technical expertise. For nearly half a century, Helsinn has been operating with integrity, passion and quality. The company continuously fosters innovation for its patients and embraces sustainable growth as a core element of its strategic vision.
Media contacts:
Patrik Strömberg, CEO
Telephone: +46 704 156 159
E-mail: [email protected]
Inlägget AnaCardio Reports Strong Phase 2a Topline Results for AC01 in patients with heart failure and reduced ejection fraction (HFrEF); Paving the Way for Rapid Advancement to Phase 2b dök först upp på AnaCardio.
]]>Inlägget AnaCardio Announces Completion of Target Enrollment in Phase 2a Study of AC01 in Heart Failure; Results Expected Year-end 2025 dök först upp på AnaCardio.
]]>In the Phase 2a part of the GOAL-HF1 study, a total of 26 patients were randomized to receive AC01 or placebo for 28 days at dose levels identified from the previously completed Phase 1b part, which dosed patients over 7 days. The study has been designed in collaboration with a panel of senior heart failure experts and is being conducted at 13 highly specialized heart failure centers in Sweden, the Netherlands, Italy and the UK.
“We are delighted to have reached full enrollment in this important study of AC01,” said Professor Roy Gardner, Principal Investigator at The Golden Jubilee National Hospital, Glasgow, UK. “This milestone brings us closer to understanding the clinical potential of this first-in-class therapy for patients with HFrEF. We eagerly look forward to the results, which could represent a significant step toward improving outcomes for this large, underserved patient population.”
“Completing the target enrollment on schedule in the Phase 2a study part is an important achievement for AnaCardio and demonstrates great execution by our team and partners,” said Elin Rosendahl, Chief Development Officer at AnaCardio. “We are excited to advance AC01 through this critical stage of development, with data expected later this year. With AC01’s novel mechanism and encouraging clinical profile to date, we believe it has the potential to transform the treatment paradigm in patients with HFrEF.”
About the GOAL-HF1 HFrEF study
The GOAL-HF1 study is a phase 1b/2a multicenter, randomized, double-blind, placebo-controlled study evaluating the safety, tolerability, pharmacokinetics and pharmacodynamics of AC01 in patients with heart failure with reduced ejection fraction (HFrEF).
In the Phase 1b study part, a total of 32 patients, 8 in each of 4 sequential dose cohorts were treated orally, twice daily with ascending doses of AC01 (0.3 to 3.0 mg) or placebo for 7 days. All patients completed the study according to plan and full target engagement was achieved within a safe dose range.
In the Phase 2a study part, 24 to 30 patients were planned to be enrolled and equally randomized into 1 of 3 parallel treatment arms and given AC01 or placebo twice daily for 28 days.
More information about the study is available at www.clinicaltrials.gov (NCT05642507).
About AnaCardio
AnaCardio AB is a privately held clinical stage biopharmaceutical company developing novel drugs to treat heart failure. AnaCardio was founded based on ground-breaking research from Karolinska Institutet showing improved contractility of the heart muscle through a unique and differentiated mechanism. The Company’s lead program AC01, a first-in-class calcium sensitizing inotrope, is an oral ghrelin mimetic small-molecule, which was in-licensed from Helsinn and is now being developed as a contractile agent in heart failure patients. The company has raised over USD 40 million to date. AnaCardio is based in Stockholm, Sweden.
Find more information about AnaCardio at www.anacardio.com and follow us on LinkedIn.
Media contacts:
Patrik Strömberg, CEO
Telephone: +46 704 156 159
E-mail: [email protected]
Inlägget AnaCardio Announces Completion of Target Enrollment in Phase 2a Study of AC01 in Heart Failure; Results Expected Year-end 2025 dök först upp på AnaCardio.
]]>Inlägget AnaCardio strengthens leadership team with appointment of Philipp Mathieu as Chief Financial Officer dök först upp på AnaCardio.
]]>Philipp is an experienced healthcare executive with two decades of leadership and investment experience across European and US markets. He has successfully led companies, driven healthcare investments, and advised on major strategic transactions across the sector. Most recently, he served as Chief Executive Officer of Immunovia AB, a publicly listed diagnostics company, and previously held senior roles in healthcare investment banking as well as advisory positions for international family offices and investors. He holds an MSc in Finance from Cass Business School, London, UK and an MSc in Economics from Georg-August University Göttingen, Germany.
Philipp Mathieu commented: “AnaCardio is one of the most exciting biotech scale-ups in the cardiovascular space and at the forefront of innovation in cardiovascular medicine, with the potential to transform the treatment of heart failure. With an exceptional team, a strong scientific foundation, and ambitious growth plans backed by leading investors, the company is uniquely positioned to make a significant impact. I am excited to join AnaCardio at this pivotal stage and to help accelerate its journey.”
“I am pleased to welcome Philipp to the AnaCardio management team. Philipp´s strong strategic mindset and extensive experience in healthcare transactions and financings will greatly strengthen our ability to advance our promising heart failure program.”, commented Patrik Strömberg, CEO.
About AnaCardio
AnaCardio AB is a privately held clinical stage biopharmaceutical company developing novel drugs to treat heart failure. AnaCardio was founded based on ground-breaking research from Karolinska Institutet showing improved contractility of the heart muscle through a unique and differentiated mechanism. The Company’s lead program AC01, a first-in-class calcium sensitizing inotrope, is an oral ghrelin mimetic small-molecule, which was in-licensed from Helsinn and is now being developed as a contractile agent in heart failure patients. The company has raised over USD 40 million to date. AnaCardio is based in Stockholm, Sweden.
Find more information about AnaCardio at www.anacardio.com and follow us on LinkedIn.
For further information, please contact:
Patrik Strömberg, CEO
Telephone: +46 704 156 159
E-mail: [email protected]
Inlägget AnaCardio strengthens leadership team with appointment of Philipp Mathieu as Chief Financial Officer dök först upp på AnaCardio.
]]>Inlägget AnaCardio announces positive scientific advice from the FDA and EMA, establishing a favourable development path for AC01 treatment of chronic HFrEF dök först upp på AnaCardio.
]]>AC01, a novel, selective oral ghrelin receptor (GHSR1a) agonist, is currently in Phase IIa (GOAL-HF1) and the advice will enable the planned Phase IIb study to satisfy both the FDA and EMA recommendations
Stockholm, Sweden, July 17, 2025 – AnaCardio, a clinical-stage biopharmaceutical company developing novel contractile agents to treat patients with heart failure today announces positive scientific advice from both the US Food and Drug Administration (FDA) and the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) on the overall development strategy for AC01, the company’s selective oral ghrelin receptor (GHSR1a) agonist, as a novel treatment of chronic heart failure with reduced ejection fraction (HFrEF).
In March/April 2025, AnaCardio requested a Type B meeting with FDA and Scientific Advice from the EMA CHMP to obtain agreement on the acceptability of the proposed CMC, non-clinical and clinical programs to support a potential future New Drug Application (NDA) and Marketing Authorization Application (MAA), respectively, and in particular of the design of the planned Phase IIb study in HFrEF patients.
The guidance provided was well aligned across agencies and supports a lean and straightforward development path to satisfy both the FDA and EMA recommendations. With the advice provided on the Phase IIb study, AnaCardio is now optimizing the plan and continuing preparations for initiation of the Phase IIb study during 2026, following the readout of the ongoing GOAL-HF1 study.
Patrik Strömberg, CEO, commented: “The favorable and well aligned opinions from the two regulatory agencies allow us to accelerate the combined clinical development program in these major territories. We are thrilled at the encouraging progress to date, as our company addresses a major unmet need for patients living with HFrEF”.
About AnaCardio
AnaCardio AB is a privately held clinical stage biopharmaceutical company developing novel drugs to treat heart failure. AnaCardio was founded based on ground-breaking research from Karolinska Institutet showing improved contractility of the heart muscle through a unique and differentiated mechanism. The Company’s lead program AC01, a first-in-class calcium sensitizing inotrope, is an oral ghrelin mimetic small-molecule, which was in-licensed from Helsinn and is now being developed as a contractile agent in heart failure patients. The company has raised over USD 40 million to date. AnaCardio is based in Stockholm, Sweden.
Find more information about AnaCardio at www.anacardio.com and follow us on LinkedIn.
About the GOAL-HF1 study
The GOAL-HF1 study is a phase 1b/2a multicenter, randomized, double-blind, placebo-controlled study evaluating the safety, tolerability, pharmacokinetics and pharmacodynamics of AC01 in patients with heart failure with reduced ejection fraction (HFrEF). The first part of GOAL-HF1 included a phase 1b multiple-dose-escalation, in a total of 32 patients, 8 in each of 4 sequential dose cohorts. Patients were treated orally, twice daily with ascending doses of AC01 (0.3 to 3 mg) or placebo for 7 days; all patients completed the study according to plan. All patients had New York Heart Association (NYHA) class II or III, an ICD for primary prevention and were treated with optimal guideline-based medical therapy for HFrEF. In the second part of the study (phase 2a, cohort expansion), up to 30 patients will be randomized into 3 treatment groups and treated for 28 days at dose levels identified on the basis of the completed phase 1b part. More information about the study is available at www.clinicaltrials.gov (NCT05642507).
Media contacts:
Patrik Strömberg, CEO
Telephone: +46 704 156 159
E-mail: [email protected]
Inlägget AnaCardio announces positive scientific advice from the FDA and EMA, establishing a favourable development path for AC01 treatment of chronic HFrEF dök först upp på AnaCardio.
]]>Inlägget AnaCardio receives patent grant in Europe for AC01 dök först upp på AnaCardio.
]]>Patrik Strömberg, AnaCardio CEO, commented: “We are pleased to have been granted an additional patent that protects our lead candidate AC01, and that will secure extended European market exclusivity into the 2040s” .
Melanie Rolli, Helsinn Group CEO, commented: “We are delighted with the issuance of this European patent, which secures the use of AC01/HM01 as an inotropic agent until 2042. This milestone highlights our commitment to innovative treatments for heart failure.”
About AnaCardio
AnaCardio AB is a privately held clinical stage biopharmaceutical company developing novel drugs to treat heart failure. AnaCardio was founded based on ground-breaking research from Karolinska Institutet showing improved contractility of the heart muscle through a unique and differentiated mechanism. The Company’s lead program AC01, a first-in-class calcium sensitizing inotrope, is an oral ghrelin mimetic small-molecule, which was in-licensed from Helsinn and is now being developed as a contractile agent in heart failure patients. The company has raised over USD 35 million to date. AnaCardio is based in Stockholm, Sweden.
Find more information about AnaCardio at www.anacardio.com and follow us on LinkedIn.
About Helsinn
Helsinn is a global pharmaceutical company that builds, manufactures, launches, and commercializes products to improve the quality of life for patients with cancer and chronic disease, with a focus on supportive care, oncology and dermato-oncology. Helsinn, headquartered in Lugano, Switzerland, has direct commercial operations in the U.S. and a consolidated network of partners to reach out to patientsin more than 190 countries worldwide.
Established in 1976, Helsinn is a fourth-generation family-owned company with broad pharmaceutical and technical expertise. Helsinn is proud of its history of operating with great integrity, passion and quality. The company is committed to continuously striving for innovation for its patients and embracing sustainable growth as a core element of its strategic vision.
To learn more about Helsinn, please visit www.helsinn.com or follow us on LinkedIn and X.
AnaCardio Media Contact:
Patrik Strömberg, CEO
Telephone: +46 704 156 159
E-mail: [email protected]
Helsinn Media Contact:
Sabrina Perucchi
Group Communication Manager
Lugano, Switzerland
Tel: +41 (0) 91 985 21 21
Inlägget AnaCardio receives patent grant in Europe for AC01 dök först upp på AnaCardio.
]]>Inlägget AnaCardio reports first patient dosed in the phase 2a study evaluating AC01 in patients with heart failure and reduced ejection fraction (HFrEF) dök först upp på AnaCardio.
]]>The phase 2a part of the GOAL-HF1 study is a randomized, double-blind, placebo-controlled study evaluating the safety, tolerability, pharmacokinetics and pharmacodynamics of AC01 following 28 days treatment in patients with HFrEF. The study has been designed in collaboration with a panel of senior heart failure experts and is being conducted at 13 highly specialized heart failure centers in Sweden, the Netherlands, Italy and the UK. Study results are expected by the end of the year.
“We are very excited to dose the first patient in this phase 2a study with AC01, a new, promising therapeutic option with potential to improve outcomes for patients with chronic advanced HFrEF. This study will help us better understand the benefits and risks over time and establish clinical proof-of-concept for this novel treatment”, said Professor Mark Petrie at the Royal Infirmary Hospital in Glasgow.
”After successfully completing the multiple-ascending-dose part of the GOAL-HF1 study, achieving full target engagement within a safe dose range, we are now thrilled to expand the evaluation of AC01 to a 4-week Randomized Clinical Trial with a broader set of exploratory efficacy endpoints and a growing team of study sites”, said Elin Rosendahl, Chief Development Officer at AnaCardio.
About AnaCardio
AnaCardio AB is a privately held clinical stage biopharmaceutical company developing novel drugs to treat heart failure. AnaCardio was founded based on ground-breaking research from Karolinska Institutet showing improved contractility of the heart muscle through a unique and differentiated mechanism. The Company’s lead program AC01, a first-in-class calcium sensitizing inotrope, is an oral ghrelin mimetic small-molecule, which was in-licensed from Helsinn and is now being developed as a contractile agent in heart failure patients. The company has raised over USD 35 million to date. AnaCardio is based in Stockholm, Sweden.
Find more information about AnaCardio at www.anacardio.com and follow us on LinkedIn.
About the GOAL-HF1 HFrEF study
The GOAL-HF1 study is a phase 1b/2a multicenter, randomized, double-blind, placebo-controlled study evaluating the safety, tolerability, pharmacokinetics and pharmacodynamics of AC01 in patients with heart failure with reduced ejection fraction (HFrEF). The first part of GOAL-HF1 included a phase 1b multiple-dose-escalation, in a total of 32 patients, 8 in each of 4 sequential dose cohorts. Patients were treated orally, twice daily with ascending doses of AC01 (0.3 to 3.0 mg) or placebo for 7 days; all patients completed the study according to plan. All patients had New York Heart Association (NYHA) class II or III, an ICD for primary prevention and were treated with optimal guideline-based medical therapy for HFrEF. In the second part of the study (phase 2a, cohort expansion), up to 30 patients will be randomized into 3 treatment groups and treated for 28 days at dose levels identified on the basis of the completed phase 1b part. More information about the study is available at www.clinicaltrials.gov (NCT05642507).
Media contacts:
Patrik Strömberg, CEO
Telephone: +46 704 156 159
E-mail: [email protected]
Inlägget AnaCardio reports first patient dosed in the phase 2a study evaluating AC01 in patients with heart failure and reduced ejection fraction (HFrEF) dök först upp på AnaCardio.
]]>Inlägget AnaCardio raises USD 19 million to advance first-in-class drug candidate AC01 for heart failure dök först upp på AnaCardio.
]]>January 9, 2025, Stockholm, Sweden – AnaCardio, a clinical-stage biopharmaceutical company developing novel contractile agents to treat patients with heart failure today announced the completion of a USD 19 million (SEK 205 million) Series A extension financing round, co-led by Novo Holdings, Pureos Bioventures and Sound Bioventures. Current investors Flerie, Industrifonden, and Fredrik and Ann-Helene Ljungström, also participated to complete the round. The raised funds will be used to complete the phase 1b/2a GOAL-HF1 study, and to prepare and initiate start-up activities for the subsequent phase 2b study.
The investment follows the successful completion of the first part of the Company’s phase 1b/2a GOAL-HF1 study in patients with HFrEF. GOAL-HF1 is the first clinical study in patients with AC01, the Company’s novel, selective oral ghrelin receptor (GHSR1a) agonist molecule, which is in development to improve contractility in patients with heart failure. AnaCardio licensed AC01 from the Helsinn Group in February 2022.
In the present study, AC01 was well-tolerated with no Treatment Emergent Adverse Event (TEAE) resulting in treatment discontinuation, and no severe TEAEs. One Serious Adverse Event (SAE) occurred in a patient receiving placebo. No clinically significant changes in blood pressure, arrhythmias or laboratory safety variables were observed. The systemic exposure of AC01 increased in direct proportion to dose and an AC01 concentration-dependent target engagement, expressed as immediate increases in systemic Growth Hormone levels, was demonstrated. Exploratory pharmacodynamic measurements of Cardiac Index and Stroke Volume showed signs of increased contractility, which will be further evaluated in the second part of GOAL-HF1, a phase 2a cohort expansion where patients will be treated for 28 days. This final part of GOAL-HF1 is due to start Q1, 2025, with results expected by the end of the year.
“The study results demonstrate that AC01 is a promising novel inotrope showing signs of increased contractility without adverse effects, such as tachycardia, arrhythmias, ischemia or hypotension which are typically seen with conventional inotropes when administered to patients with heart failure. AC01 proved to be well-tolerated and showed convincing target engagement meriting advancement to the next development stage testing the drug for 28 days to establish proof-of-concept and enable progress to late-stage clinical development”, commented Professor Lars Lund, CSO and Founder of AnaCardio.
AnaCardio’s CEO Patrik Strömberg commented, “This is a landmark day for AnaCardio, where we report a significant financing round, welcome three prominent new investors, and announce the positive outcome of the first study with AC01 in patients. We now have the data and funding to accelerate the further clinical development of our first-in-class inotrope to improve the lives of patients with heart failure”.
“Heart failure with reduced ejection fraction remains a major unmet medical need, affecting millions of lives worldwide. We are thrilled to be part of this groundbreaking initiative and proud to support the development of a new therapeutic option that has the potential to significantly improve outcomes for patients facing this challenging condition,” said Johan Kördel, Managing Partner, Sound Bioventures.
In connection with the new investment, Johan Kördel (Managing Partner, Sound Bioventures), Jørgen Søberg Petersen (Senior Partner, Novo Holdings) and Veronica Gambillara Fonck (Partner, Pureos Bioventures) will join AnaCardio’s Board of Directors. In addition, Viktor Drvota (CEO, Karolinska Development) will replace Per Aniansson on the AnaCardio board. As part of the transaction, Karin Hehenberger, Advisor, 3BFuture Health will transition to a board observer role.
About AnaCardio
AnaCardio AB is a privately held clinical stage biopharmaceutical company developing novel drugs to treat heart failure. AnaCardio was founded based on ground-breaking research from Karolinska Institutet showing improved contractility of the heart muscle through a unique and differentiated mechanism. The Company’s lead program AC01, a first-in-class calcium sensitizing inotrope, is an oral ghrelin mimetic small-molecule, which was in-licensed from Helsinn and is now being developed as a contractile agent in heart failure patients. The company has raised over USD 35 million to date. AnaCardio is based in Stockholm, Sweden.
Find more information about AnaCardio at www.anacardio.com and follow us on LinkedIn.
Media contacts:
Patrik Strömberg, CEO
Telephone: +46 704 156 159
E-mail: [email protected]
About the GOAL-HF1 HFrEF study
The GOAL-HF1 study is a Phase 1b/2a multicenter, randomized, double-blind, placebo-controlled study evaluating the safety, tolerability, pharmacokinetics and pharmacodynamics of AC01 in patients with heart failure with reduced ejection fraction (HFrEF). The now completed first part of GOAL-HF1 included a phase 1b multiple-dose-escalation, and a total of 32 patients, 8 in each of 4 sequential dose cohorts, were treated orally, twice daily with ascending doses of AC01 (0.3 to 3.0 mg) or placebo for 7 days; all patients completed the study according to plan. All patients had New York Heart Association (NYHA) class II or III, an ICD for primary prevention and were treated with optimal guideline-based medical therapy for HFrEF. More information about the study is available at www.clinicaltrials.gov (NCT05642507).
About Helsinn
Helsinn is a global pharmaceutical company that builds, manufactures, launches, and commercializes products to improve the quality of life for patients with cancer and chronic disease, with a focus on supportive care, oncology and dermato-oncology. Helsinn, headquartered in Lugano, Switzerland, has direct commercial operations in the U.S. and an extensive network of long-standing trusted partners enabling a commercial presence in more than 90 countries.
Established in 1976, Helsinn is a fourth-generation family-owned company with broad pharmaceutical and technical expertise. Helsinn is proud of its history of operating with great integrity, passion and quality. The company is committed to continuously striving for innovation for its patients and embracing sustainable growth as a core element of its strategic vision.
To learn more about Helsinn, please visit www.helsinn.com or follow us on LinkedIn and X.
About Novo Holdings A/S
Novo Holdings is a holding and investment company that is responsible for managing the assets and the wealth of the Novo Nordisk Foundation. The purpose of Novo Holdings is to improve people’s health and the sustainability of society and the planet by generating attractive long-term returns on the assets of the Novo Nordisk Foundation.
Wholly owned by the Novo Nordisk Foundation, Novo Holdings is the controlling shareholder of Novo Nordisk and Novonesis and manages an investment portfolio with a long-term return perspective. In addition to managing a broad portfolio of equities, bonds, real estate, infrastructure and private equity assets, Novo Holdings is a world-leading life sciences investor. Through its Seed, Venture, Growth, Planetary Health Investments and Principal Investments teams, Novo Holdings invests in life science companies at all stages of development.
As of year-end 2023, Novo Holdings had total assets of EUR 149 billion.
For more information, please visit Novo Holdings.
About Pureos Bioventures
Pureos Bioventures are a series of venture capital funds advised by Swiss-based Pureos Partners that invest exclusively in private innovative drug development companies, with a special emphasis on the next generation of biological drugs and drug formats. The funds’ portfolio companies are built on scientific excellence to develop therapies across a broad indication spectrum including oncology, cardiometabolic, ophthalmology, infectious disease, and neuroscience. Pureos has built a team with in-depth investment, operating and clinical expertise, that strives to impact patients’ lives by advancing innovative treatments for devastating diseases. For further information, please visit www.pureosbio.com.
About Sound Bioventures
Sound Bioventures is a specialist life sciences venture capital fund investing in about-to-be clinical or clinical stage private companies in Europe and the USA developing therapeutics in areas of significant clinical unmet need. The founding team has an active approach to investing and brings considerable operational and VC investment experience, including working together on over 40 investments over the past 15 years. Sound Bioventures operates from Malmö and Stockholm (Sweden), Copenhagen (Denmark) and Washington DC (USA). For more information, see Sound Bioventures.
Inlägget AnaCardio raises USD 19 million to advance first-in-class drug candidate AC01 for heart failure dök först upp på AnaCardio.
]]>Inlägget AnaCardio successfully completes first part of AC01 HFrEF study and provides a clinical update dök först upp på AnaCardio.
]]>AnaCardio, a Swedish clinical-stage biopharmaceutical company developing novel contractile agents to treat patients with heart failure, today announced that the clinical conduct of the first part of its GOAL-HF1 study in patients with heart failure and reduced ejection fraction (HFrEF) has been completed. Part A of GOAL-HF1 is a randomized, double-blind, placebo-controlled, dose-escalation study (Phase 1b), designed to assess the safety, pharmacokinetic and pharmacodynamic properties of AC01. A total of 32 patients, 8 in each of 4 sequential dose cohorts, were treated with ascending doses of AC01 or placebo for 7 days; all patients completed the study according to plan. The cohort extension phase of GOAL-HF1 (Part B/Phase 2a) is expected to be initiated in Q1’25. More information about the study is available at www.clinicaltrials.gov (NCT05642507).
AnaCardio also announces the completion of the AC01-FE study, conducted in the US, evaluating the effects of food on the pharmacokinetics of AC01 in healthy volunteers. All 24 participants completed the study; AC01 was safe and well-tolerated under both fed and fasted conditions.
”The successful completion of these studies represents a significant development milestone for AC01. We are encouraged by the emerging data and clinical experience with AC01, which support advancement to the next part of GOAL-HF1 where we will treat patients with HFrEF for a longer duration in a Phase 2a setting, as well as intensifying our preparations for subsequent larger trials.” commented Allan Gordon, Chief Medical Officer AnaCardio.
About AnaCardio
AnaCardio AB is a privately held Swedish, clinical stage biopharmaceutical company developing novel drugs to treat heart failure. AnaCardio was founded based on ground-breaking research from Karolinska Institutet showing improved contractility of the heart muscle through a unique and differentiated mechanism. Its lead program AC01 is an oral ghrelin peptidomimetic small-molecule is being developed as a contractile agent in heart failure patients.
You can find more information about AnaCardio at www.anacardio.com.
For further information, please contact
Patrik Strömberg, CEO
Telephone: +46 704 156 159
E-mail: [email protected]
Inlägget AnaCardio successfully completes first part of AC01 HFrEF study and provides a clinical update dök först upp på AnaCardio.
]]>Inlägget Michael Grissinger appointed as new Chairman of AnaCardio dök först upp på AnaCardio.
]]>AnaCardio, a Swedish clinical-stage biopharmaceutical company focusing on developing novel contractile agents to treat patients with heart failure, announces today the appointment of Michael Grissinger, B.S M.B.A. as new chairman of the board.
Michael has had a long and successful career in the pharmaceutical industry, leading large value business development transactions across multiple therapeutic areas and products. Michael spent more than two decades at Johnson & Johnson, holding positions of Vice President and Head, Worldwide Pharmaceutical Licensing as well as Vice President and Head of Worldwide Pharmaceutical Corporate Development and
M&A. Since his retirement in 2018, Michael has served on the boards of several public biotechnology companies. He holds a B.S. in Chemistry from Juniata College and an M.B.A. from Temple University-Fox School of Business.
Michael Grissinger commented: “AnaCardio, with its promising novel concept to treat heart failure, is an exciting Swedish company with potential to address a significant unmet patient need. I am looking forward to being a part of the journey forward.”
Mark Quick, board member, Partner at Flerie and outgoing chairman commented: “We are delighted to welcome Michael to the board as the new chairman. With his long tenure and track record in business development and M&A at leading pharma companies, he brings the exact credentials required to continue building the AnaCardio success story.”
About AnaCardio
AnaCardio AB is a privately held Swedish, clinical stage biopharmaceutical company developing novel drugs to treat heart failure. AnaCardio was founded based on ground-breaking research from Karolinska Institutet showing improved contractility of the heart muscle through a unique and differentiated mechanism. Its lead program AC01 is an oral ghrelin peptidomimetic small-molecule, which is being developed as a contractile agent in heart failure patients.
You can find more information about AnaCardio at www.anacardio.com.
For further information, please contact
Patrik Strömberg, CEO
Telephone: +46 704 156 159
E-mail: [email protected]
Inlägget Michael Grissinger appointed as new Chairman of AnaCardio dök först upp på AnaCardio.
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