The post Atea Pharmaceuticals Announces Strategic Collaboration with Roche to Develop and Distribute AT-527 for Patients with COVID-19 appeared first on Atea Pharmaceuticals.
]]>BOSTON, Mass., October 22, 2020 – Atea Pharmaceuticals, Inc., a clinical stage biopharmaceutical company focused on discovering, developing and commercializing antiviral therapeutics to improve the lives of patients suffering from life-threatening viral infections, today announces that the company has entered into an agreement with Roche (SIX: RO, ROG; OTCQX: RHHBY) for the exclusive rights to research, develop and distribute AT-527 as an oral antiviral treatment for COVID-19 in territories outside of the United States. Under the terms of the agreement, Atea will receive an upfront payment of $350 million in cash from Roche with the potential for future milestone payments and royalties.
“Roche shares our passion for delivering innovative new medicines to address great unmet medical needs. The COVID-19 pandemic has highlighted the urgent need for a novel, oral antiviral to treat this highly infectious and often deadly virus,” said Jean-Pierre Sommadossi, Ph.D., Chief Executive Officer and Founder of Atea Pharmaceuticals. “This collaboration with Roche enhances Atea’s efforts and underscores the potential for AT-527 to effectively address the COVID-19 crisis on a global scale. AT-527 is expected to be ideally suited to combat COVID-19 as it inhibits viral replication by interfering with viral RNA polymerase, a key component in the replication machinery of RNA viruses. Importantly, the manufacturing process for our small molecule direct-acting antiviral allows us to produce AT-527 quickly and at scale.”
“The ongoing complexities of COVID-19 require multiple lines of defence. By joining forces with Atea, we hope to offer an additional treatment option for hospitalised and non-hospitalised COVID-19 patients, and provide important relief for hospital infrastructures during a global pandemic.” said Bill Anderson, Chief Executive Officer of Roche Pharmaceuticals. “In jointly developing and manufacturing AT-527 at scale, we seek to make this treatment option available to as many people around the world as we possibly can.”
About AT-527
AT-527 is an orally administered, direct-acting antiviral agent derived from Atea’s purine nucleotide prodrug platform. At-527 is currently under evaluation as a treatment for patients with COVID-19. AT-527 is designed to inhibit viral replication by interfering with viral RNA polymerase, a key component in the replication machinery of RNA viruses, such as positive single-stranded human flaviviruses and human coronaviruses. AT-527 is currently in a global Phase 2 clinical study for hospitalized patients with moderate COVID-19 and has plans to initiate a global, registrational Phase 3 clinical trial in outpatients in the first half of 2021. Additionally, Atea is planning to study in a Phase 3 clinical trial the use of AT-527 in the post-exposure prophylaxis setting.
Advisors
Evercore served as exclusive financial advisor to Atea in connection with this transaction.
About Atea Pharmaceuticals
Atea Pharmaceuticals is a clinical stage biopharmaceutical company engaged in discovering and developing therapies to address the unmet medical needs of patients with severe viral diseases. Our lead programs are focused on the development of orally- administered direct acting antivirals for the treatment of patients with COVID-19 in the hospital and community settings, the treatment of patients with chronic hepatitis C infection, the treatment of patients with dengue, and the treatment of high-risk patients with severe respiratory syncytial virus infection. Our medicinal chemistry, virology, and pharmacology expertise, bolstered by our collective experience in drug development, enables us to pioneer new advancements in antiviral science. Leveraging the power of our purine nucleotide prodrug platform, our goal is to rapidly advance novel drug candidates with optimal therapeutic profiles for RNA virus targets. Founded by its Chairman and Chief Executive Officer, Jean-Pierre Sommadossi, PhD, Atea began operations in 2014 and is headquartered in Boston, MA. For more information about Atea and our pipeline of product candidates please visit our company website at www.ateastgwp.ycms2.com.
Contacts
Investors:
Will O’Connor
Stern Investor Relations
212-362-1200
[email protected]
Media:
Carol Guaccero
301-606-4722
[email protected]
The post Atea Pharmaceuticals Announces Strategic Collaboration with Roche to Develop and Distribute AT-527 for Patients with COVID-19 appeared first on Atea Pharmaceuticals.
]]>The post Atea Pharmaceuticals Appoints Polly Murphy, D.V.M, Ph.D., to the Board of Directors appeared first on Atea Pharmaceuticals.
]]>BOSTON, Mass., September 14, 2020 – Atea Pharmaceuticals, Inc., a biopharmaceutical company engaged in the discovery and development of next- generation therapeutics for severe viral infections, today announced the appointment of Polly Murphy, D.V.M., Ph.D., Chief Business Officer of UroGen Pharma, to its Board of Directors. Dr. Murphy is a seasoned pharmaceutical executive with a wide range of experience spanning research and development, strategy and operations.
“We are thrilled to welcome Dr. Murphy to Atea’s Board of Directors as her expertise and leadership in clinical, business and commercial development will be invaluable as we continue to advance our pipeline of antiviral product candidates. Her insight and guidance will be particularly beneficial as we accelerate the development of AT-527 as an oral treatment for patients with COVID-19,” said Jean-Pierre Sommadossi, Ph.D., Chief Executive Officer and Founder of Atea Pharmaceuticals.
“It is an honor to join Atea’s Board particularly at this time when there is such urgent need for safe and effective antiviral therapeutics. I am looking forward to working closely with this dedicated team to advance development and commercialization of AT-527 and other product candidates which may transform clinical outcomes for patients with life threatening viral diseases,” commented Dr. Murphy.
Prior to joining UroGen, Dr. Murphy held several senior leadership positions at Pfizer, including commercial development leadership in the Pfizer Oncology Business Unit and at Pfizer China where she was responsible for business and commercial development, as well as strategy and innovation for the company’s biopharmaceutical business in China. Earlier, she held senior positions at The Scripps Research Institute and The Salk Institute for Biological Studies.
Dr. Murphy earned a D.V.M. and Ph.D. in Veterinary Pathology from Iowa State University and an M.B.A. from Nova Southeastern University.
About Atea Pharmaceuticals
Atea Pharmaceuticals is a clinical stage biopharmaceutical company engaged in discovering and developing therapies to address the unmet medical needs of patients with severe viral diseases. Our lead programs are focused on the development of orally- administered direct acting antivirals for the treatment of patients with COVID-19 in the hospital and community settings, the treatment of patients with chronic hepatitis C infection, the treatment of patients with dengue, and the treatment of high-risk patients with severe respiratory syncytial virus infection. Our medicinal chemistry, virology, and
pharmacology expertise, bolstered by our collective experience in drug development, enables us to pioneer new advancements in antiviral science. Leveraging the power of our purine nucleotide prodrug platform, our goal is to rapidly advance novel drug candidates with optimal therapeutic profiles for RNA virus targets. Founded by our Chairman and Chief Executive Officer, Jean-Pierre Sommadossi, PhD, Atea began operations in 2014 and is headquartered in Boston, MA. For more information about Atea and our pipeline of product candidates please visit our company website at ateastgwp.ycms2.com.
Contacts
Investors:
Will O’Connor
Stern Investor Relations
[email protected]
Media:
Carol Guaccero
301-606-4722
[email protected]
The post Atea Pharmaceuticals Appoints Polly Murphy, D.V.M, Ph.D., to the Board of Directors appeared first on Atea Pharmaceuticals.
]]>The post Atea Pharmaceuticals Strengthens Management Team with Appointment of Clinical and Regulatory Leadership appeared first on Atea Pharmaceuticals.
]]>BOSTON, Mass., August 24, 2020 – Atea Pharmaceuticals, Inc., a biopharmaceutical company engaged in the discovery and development of next-generation therapeutics for severe human viral infections, today announced the appointments of Arantxa Horga, M.D., as Executive Vice President of Clinical Sciences and Mihaela Mac Nair, Ph.D., as Vice President of Regulatory.
“These new additions to our leadership team will provide critical guidance as we approach late-stage clinical development of AT-527 as a treatment for COVID-19,” said Jean-Pierre Sommadossi, Ph.D., Founder, Chairman and Chief Executive Officer of Atea. “Collectively, Arantxa and Mihaela’s experience and clinical expertise will be invaluable as we both advance our current programs and expand our pipeline of oral direct acting antivirals to combat severe viral infections.”
Dr. Horga is an expert in infectious diseases drug development with over 15 years of broad biopharmaceutical experience including clinical development program leadership, clinical operations and pharmacovigilance. She joins Atea from Biohaven Pharmaceuticals, where she served as Vice President, Pharmacovigilance and Medical Affairs. Before that, she was at Hoffmann-La Roche where she served as Vice President, Global Head of Clinical Program Execution, Site Head of the Roche NY Innovation Center and as Global Head of Translational Medicine, Infectious Diseases. Dr. Horga began her career in drug discovery and development at Bristol-Myers Squibb where she rose through a series of clinical leadership positions to become Group Director, Global Clinical Research, Virology. She holds an M.D. from the Santander School of Medicine, and completed her residency in Pediatrics and fellowship in Pediatric Infectious Diseases at the Mount Sinai School of Medicine, where she remained as faculty. During her academic tenure, her NIH-funded laboratory research focused on mechanisms of pathogenesis of respiratory viruses.
Dr. MacNair joins Atea from Biogen, where she served as Senior Director of Global Regulatory Affairs and Regulatory Therapeutic Area Head covering neurodegenerative and neuromuscular diseases. Having started her career in the pharmaceutical industry in the EU, Dr. MacNair has pursued opportunities in the US where she held positions of increasing global responsibility with pharmaceutical companies including Vertex Pharmaceuticals, Alkermes, and Shire (now Takeda Pharmaceuticals).
Dr. MacNair holds an M.Sc. in Organic Chemistry from the Polytechnical Institute of Bucharest, Romania, and an M.Sc. in Pharmaceutical Products Development and International Registration from Université Paris-Sud, France. Dr. MacNair holds a Ph.D. in Analytical Spectrochemistry from Université Paris 7, Denis Diderot, France.
About Atea Pharmaceuticals
Atea Pharmaceuticals is a clinical stage biopharmaceutical company engaged in discovering and developing therapies to address the unmet medical needs of patients with severe viral diseases. Our lead programs are focused on the development of orally- administered direct acting antivirals for the treatment of patients with COVID-19 in the hospital and community settings, the treatment of patients with chronic hepatitis C infection, the treatment of patients with dengue, and the treatment of high-risk patients with severe respiratory syncytial virus infection. Our medicinal chemistry, virology, and pharmacology expertise, bolstered by our collective experience in drug development, enables us to pioneer new advancements in antiviral science. Leveraging the power of our purine nucleotide prodrug platform, our goal is to rapidly advance novel drug candidates with optimal therapeutic profiles for RNA virus targets. Founded by its Chairman and Chief Executive Officer, Jean-Pierre Sommadossi, PhD, Atea began operations in 2014 and is headquartered in Boston, MA. For more information about Atea and our pipeline of product candidates please visit our company website at ateastgwp.ycms2.com.
Contact
Investors:
Will O’Connor
Stern Investor Relations
212-362-1200
[email protected]
Media:
Carol Guaccero
301-606-4722
[email protected]
The post Atea Pharmaceuticals Strengthens Management Team with Appointment of Clinical and Regulatory Leadership appeared first on Atea Pharmaceuticals.
]]>The post Atea Pharmaceuticals Appoints Janet Hammond, M.D., Ph.D., as Chief Development Officer appeared first on Atea Pharmaceuticals.
]]>BOSTON, Mass., August 10, 2020 – Atea Pharmaceuticals, Inc., a biopharmaceutical company engaged in the discovery and development of next-generation therapeutics for severe human viral infections, today announced the appointment of Janet Hammond, M.D., Ph.D., Sc.M., F.C.P., to the newly-created position of Chief Development Officer. Dr. Hammond will be responsible for overseeing Atea’s clinical development programs, specifically spearheading its development of AT-527 for the treatment of COVID-19. “We are delighted to welcome Janet to the Atea leadership team and are confident that her considerable expertise in virology and antiviral therapeutics will enhance our development programs. Janet has extensive experience with infectious and respiratory diseases, which should be invaluable to Atea as we move to expedite our clinical studies of AT-527 as a treatment for COVID-19,” said Jean-Pierre Sommadossi, Ph.D., Founder, Chairman and Chief Executive Officer of Atea. “We look forward to working with Janet as we build Atea into a leader in the discovery of oral direct acting antivirals to combat COVID-19 and other severe viral infections.”
“I am excited to be joining Atea as together we work to advance a pipeline of versatile antivirals to fight deadly diseases. In particular, we are driven to focus on providing a new treatment for COVID-19 where there is an immediate and unmet medical need,” said Dr. Hammond.
Dr. Hammond joins Atea from AbbVie, Inc. where she served as Vice President and Therapeutic Area Head for General Medicine and Infectious Disease Development. Before that, she served as Senior Vice President, Global Head of Infectious Diseases and Head of pRED China at Hoffmann-La Roche. Earlier, she served as Chief Medical Officer, Senior Vice President and Head of Medical Affairs at Valeant Pharmaceuticals. Prior to that, she was Group Director in Global Clinical Research, Virology and Infectious Diseases at Bristol-Myers Squibb. Dr. Hammond began her career in drug discovery and development at GlaxoSmithKline where she rose through a series of clinical leadership positions to become Head of Clinical Drug Discovery, Virology.
Dr. Hammond holds an M.D. and Ph.D. from the University of Cape Town, South Africa. She holds a Sc.M. in Clinical Investigation from Johns Hopkins University School of Hygiene and Public Health. Dr. Hammond is a Fellow of the South African College of Physicians in Internal Medicine.
Dr. Hammond completed her residency in Internal Medicine and fellowship in Critical Care at the University of Cape Town, South Africa. In addition, she completed a Post-Doctorate Clinical and Research Fellowship at Johns Hopkins University School of Medicine.
About Atea Pharmaceuticals
Atea Pharmaceuticals is a clinical stage biopharmaceutical company engaged in discovering and developing therapies to address the unmet medical needs of patients with severe viral diseases. Our lead programs are focused on the development of orally- administered direct acting antivirals for the treatment of patients with mild to moderate COVID-19 in the hospital and community settings, the treatment of patients with chronic hepatitis C infection, the treatment of patients with dengue, and the treatment of high- risk patients with severe respiratory syncytial virus infection. Our medicinal chemistry, virology, and pharmacology expertise, bolstered by our collective experience in drug development, enables us to pioneer new advancements in antiviral science. Leveraging the power of our purine nucleotide prodrug platform, our goal is to rapidly advance novel drug candidates with optimal therapeutic profiles for RNA virus targets. Founded by its Chairman and Chief Executive Officer, Jean-Pierre Sommadossi, PhD, Atea began operations in 2014 and is headquartered in Boston, MA. For more information about Atea and our pipeline of products please visit our company website at ateastgwp.ycms2.com.
Contact
Investors:
Will O’Connor
Stern Investor Relations
212-362-1200
[email protected]
Media:
Carol Guaccero
301-606-4722
[email protected]
The post Atea Pharmaceuticals Appoints Janet Hammond, M.D., Ph.D., as Chief Development Officer appeared first on Atea Pharmaceuticals.
]]>The post Atea Pharmaceuticals Announces IND Clearance of AT-527 for COVID-19 and $215 Million Financing appeared first on Atea Pharmaceuticals.
]]>BOSTON, Mass., May 20, 2020 – Atea Pharmaceuticals, Inc., a biopharmaceutical company engaged in the discovery and development of next-generation therapeutics for severe human viral infections, today announced a $215 million Series D financing. The financing was led by Bain Capital Life Sciences and also included new investors RA Capital Management, Perceptive Advisors, Rock Springs Capital, Adage Capital Management, Redmile Group, Omega Funds, and funds and accounts managed by T. Rowe Price Associates, Inc. Existing Atea investors, including Morningside Ventures, Cormorant Asset Management, Ally Bridge Group, and Sectoral Asset Management, as well as other investors also participated in this financing.
Atea also announced today that the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug application (IND) for AT-527, a novel, oral, purine nucleotide prodrug, for the treatment of adult patients hospitalized with moderate COVID-19 disease, with one or more risk factors for poor outcomes. A Phase 2 clinical trial, scheduled to begin shortly, will evaluate the safety and efficacy of AT-527 in this patient population.
AT-527 is a highly selective, orally administered direct acting antiviral, (DAA) designed to inhibit the RNA polymerase enzyme, a key element in the replication machinery of RNA viruses. Antiviral activity of AT-527 has been observed in vitro and in vivo against replication of multiple RNA viruses including, but not limited to, human coronaviruses and flaviviruses.
In addition to supporting its work to find a treatment for COVID-19, Atea expects to also apply proceeds from this financing towards advancing its diverse pipeline of highly selective DAAs that target other severe RNA viral infections. Atea’s pipeline currently includes investigative treatments for hepatitis C virus, dengue virus, and respiratory syncytial virus, in addition to its COVID-19 program.
“We are delighted to have the strong support of this group of blue-chip healthcare investors,” said Jean-Pierre Sommadossi, PhD, Atea’s Founder, Chairman, and Chief Executive Officer. “Atea’s portfolio is focused on developing novel, best-in-class, potent DAA’s and we have shifted all of our immediate resources and our team’s deep expertise in virology and pharmacology to help address the unmet needs in the fight against the COVID-19 pandemic. An oral treatment for COVID-19 patients should prevent progression of the disease and may help lessen the burden on critical inpatient resources. Atea is moving rapidly, in concert with regulatory authorities, to determine if our oral DAA is a safe and effective therapeutic against COVID-19.”
“Atea’s team has an outstanding track record in developing novel, potent DAAs, which we believe can contribute to the urgent fight against the COVID-19 pandemic and other RNA viruses,” said Andrew Hack, M.D., Ph.D., Managing Director of Bain Capital Life Sciences. “We are pleased to partner with Atea’s leadership team and an outstanding group of leading healthcare investors as Atea advances its diverse pipeline of transformative antiviral medicines”
About AT-527
AT-527 is an investigational, oral, purine nucleotide prodrug, which has demonstrated in vitro and in vivo antiviral activity against several enveloped single-stranded RNA viruses, including human flaviviruses and coronaviruses. This highly selective purine nucleotide prodrug was designed to uniquely inhibit viral RNA dependent RNA polymerase, an enzyme that is essential for the replication of RNA viruses. Antiviral activity and safety of AT-527 has been demonstrated in Phase 2 clinical studies of hepatitis C patients. AT-527 is not yet licensed or approved for any indication in the U.S. or any other country.
About Atea Pharmaceuticals
Atea Pharmaceuticals is a clinical stage biopharmaceutical company engaged in discovering and developing best-in-class therapies to address the unmet medical needs of patients with severe viral diseases. Our lead programs are focused on the development of orally-administered direct acting antivirals for the treatment of patients with mild to moderate COVID-19 in the hospital and community settings, the treatment of patients with chronic hepatitis C infection, the treatment of patients with dengue, and the treatment of high-risk patients with severe respiratory syncytial virus infection. Our medicinal chemistry, virology, and pharmacology expertise, bolstered by our collective experience in drug development, enables us to pioneer new advancements in antiviral science. Leveraging the power of our purine nucleotide prodrug platform, our goal is to rapidly advance novel drug candidates with optimal therapeutic profiles for RNA virus targets. Founded by its Chairman and Chief Executive Officer, Jean-Pierre Sommadossi, PhD, Atea began operations in 2014 and is headquartered in Boston, MA. For more information about Atea and our pipeline of products please visit our company website at ateastgwp.ycms2.com.
Contact
Company:
Natalie Lelless
Toll free: 833-325-0214
Local: 857-200-0830
[email protected]
Investors:
Constantine Davides
Westwicke Partners
Tel: 339-970-2846
[email protected]
The post Atea Pharmaceuticals Announces IND Clearance of AT-527 for COVID-19 and $215 Million Financing appeared first on Atea Pharmaceuticals.
]]>The post Atea Pharmaceuticals to present positive clinical data with AT-527 for the treatment of chronic Hepatitis C in patients with cirrhosis at The Liver Meeting® 2018 appeared first on Atea Pharmaceuticals.
]]>BOSTON, Mass., November 9, 2018 – Atea Pharmaceuticals, Inc., a biopharmaceutical company engaged in the development of next-generation therapeutics for the treatment of hepatitis C and other single stranded RNA viral infections, today announced it will present positive data from its recently completed Phase IB/IIA trial of AT-527 in treatment-naïve HCV-infected patients, including HCV-infected patients with Child-Pugh A (CPA) cirrhosis. The data will be presented on November 10, 2018 at The Liver Meeting® 2018 sponsored by the American Association for the Study of Liver Diseases taking place in San Francisco, California.
“Despite the introduction of direct acting antiviral therapies in recent years, hepatitis C continues to represent a serious global health burden, particularly among GT-3 infected, cirrhotic and other difficult-to-treat patient populations,” stated Jean-Pierre Sommadossi, PhD, Atea’s Founder, Chairman and Chief Executive Officer. “We are very excited about the clinical profile of AT-527, which has demonstrated significant antiviral potency in HCV-infected subjects, regardless of genotype or cirrhotic status. Based upon the results from our proof of concept clinical trial, we believe AT-527 may be the backbone of the first drug regimen that allows for 8-week treatment in both cirrhotic and non-cirrhotic patients. We look forward to advancing AT-527 into Phase II development in 2019.”
Poster No. 1002
Title: AT-527, a purine nucleotide prodrug, exhibits potent pan-genotypic antiviral activity in HCV-infected subjects with cirrhosis
Date/Time: Saturday, November 10, 2018; 2:00 pm – 7:30 pm PST
Location: Moscone Center North/South Building, Hall C
A summary of the data to be presented shows rapid and potent pan-genotypic antiviral activity in HCV-infected subjects with cirrhosis, as in non-cirrhotic subjects, with a mean HCV reduction of 2.4 log 10 IU/mL after a single dose and a mean maximum HCV RNA reduction of 4.6 log10 IU/mL after 7 days of dosing with AT-527 550 mg. Previously reported data also show a mean maximum HCV RNA reduction of 4.4 log10 IU/mL after 7 days of dosing of AT-527 550 mg in NC GT-1b HCV-infected subjects, and a mean reduction of 4.5 log10 IU/mL after 7 days of dosing was achieved in NC GT-3 HCV-infected subjects. No serious adverse events, dose-limiting toxicities or premature discontinuations were observed, and pharmacokinetic data (PK) in cirrhotic subjects was similar to non-cirrhotic subjects. Emax modeling demonstrated that a dose of 550 mg QD will result in maximum viral load reduction.
About the Trial
The five-part, Phase IB/IIA trial studied single and multiple doses of AT-527 in healthy and HCV-infected subjects. All HCV-infected subjects were treatment-naïve with HCV RNA ≥ 5 log10 IU/mL. The objectives of the study were to assess safety/tolerability, pharmacokinetics (PK) and antiviral activity.
The trial evaluated single oral doses up to 367 mg (400 mg salt form) in healthy subjects (Part A), single doses up to 550 mg (600 mg salt form) in NC GT-1b HCV-infected subjects (Part B) and multiple doses up to 550 mg once-daily (QD) for 7 days in NC GT-1b HCV-infected subjects (Part C). Additional cohorts evaluated 550 mg QD for 7 days in NC GT-3 (Part D) and CPA cirrhotic GT-1b/3 (Part E) HCV-infected subjects. Plasma levels of AT-273, the nucleoside metabolite of the active triphosphate, were measured using LC-MS/MS; HCV RNA was quantified using COBAS® AmpliPrep/TaqMan® HCV Test v2.0 with a limit of quantitation (LOQ) of 15 IU/mL.
About AT-527
AT-527, a proprietary investigational agent discovered at Atea, is the salt form of a purine nucleotide prodrug NS5B polymerase inhibitor. Unique structural modifications of AT-527 result in differentiated pharmacologic and antiviral properties as compared to other anti-HCV nucleotides. AT-511, the free base of AT-527, showed potent antiviral activity in vitro against wild-type clinical isolates with EC95 values less than 80 nM in all HCV genotypes, and demonstrated about 10- to 14-fold more potency than sofosbuvir (SOF) in GT-1 and GT-3 replicons. AT-511 maintained activity against SOF-resistant S282T single and S282T/L159F double variants, with about 50-fold greater potency than SOF.
About Hepatitis C
Hepatitis C is a blood-borne infectious disease of the liver and is a leading cause of chronic liver disease and transplants. According to the World Health Organization, over 70 million people suffer from chronic hepatitis C. Direct-acting antiviral agents (DAAs) have markedly improved the prognosis of many patients infected with the hepatitis C virus and allow the achievement of a cure in 8 – 12 weeks in select patient populations. Further shortening of the treatment duration in those patients and extending it to more difficult-to-treat HCV patient populations continues to be a sought-after goal of the biotech and pharma industry. Global sales of DAAs for the treatment of HCV infection are expected to exceed $8 billion in 2018.
About Atea
Atea Pharmaceuticals is a clinical stage biopharmaceutical company engaged in the discovery and development of proprietary and novel therapeutics for the treatment of hepatitis C and other single stranded RNA viral infections. Atea was founded in 2013 by its Chairman and Chief Executive Officer Jean-Pierre Sommadossi, PhD, and is headquartered in Boston, MA.
Contact:
Company:
Andrea J. Corcoran
617-669-4272
[email protected]
Investors and Media:
Constantine Davides
Westwicke Partners
Tel: 339-970-2846
[email protected]
The post Atea Pharmaceuticals to present positive clinical data with AT-527 for the treatment of chronic Hepatitis C in patients with cirrhosis at The Liver Meeting® 2018 appeared first on Atea Pharmaceuticals.
]]>The post Atea Pharmaceuticals reports positive proof of concept clinical data with AT-527 for the treatment of chronic Hepatitis C appeared first on Atea Pharmaceuticals.
]]>BOSTON, Mass., April 12, 2018 – Atea Pharmaceuticals, Inc., a biopharmaceutical company engaged in the development of next-generation therapeutics for the treatment of hepatitis C and other single stranded RNA viral infections, today reported positive data from its ongoing clinical trial of AT-527 in patients with GT-1b and GT-3 HCV infection. The company will present the data today at The International Liver Congress™ 2018 sponsored by the European Association for the Study of the Liver taking place in Paris, France.
“Although the introduction of new therapies has improved cure rates in recent years, hepatitis C continues to represent a serious global health burden, particularly within more difficult-to-treat patient populations. Given the limitations of currently available agents, we are very excited about the emerging clinical profile of AT-527, a novel, highly differentiated purine nucleotide prodrug, which has an attractive safety profile and very significant antiviral potency. Most notably, preliminary data indicate that AT-527 exhibits potent antiviral activity, regardless of genotype or cirrhosis status in HCV-infected subjects,” stated Jean-Pierre Sommadossi, PhD, Atea’s Founder, Chairman and Chief Executive Officer.
Poster No. THU-341
Title: AT-527, a pan-genotypic purine nucleotide prodrug, exhibits potent antiviral activity in subjects with chronic hepatitis C
Date/Time: Thursday, April 12, 2018; 9:00 am – 5:00 pm CET
A summary of the data to be presented shows a mean maximum HCV RNA reduction of 2.3 log10 IU/mL after a single dose, and 4.4 log10 IU/mL after 7 days of dosing, of AT-527 in NC GT-1b HCV-infected subjects. A mean reduction of 2.4 log10 IU/mL after first dose and 4.6 log10 IU/mL after 7 days of dosing was achieved in NC GT-3 HCV-infected subjects, respectively. In ongoing cohorts, antiviral activity in Child Pugh A cirrhotic GT-1b/3 HCV infected subjects was similar to NC GT-1b and NC GT-3 cohorts. Emax modeling confirms the clinical observation that 550 mg AT-527 QD will produce maximum efficacy. No serious adverse events, dose-limiting toxicities or premature discontinuations were observed.
About the Trial
The five part study commenced patient enrollment in 2017, and was designed to assess the safety and efficacy of single and multiple doses of AT-527 in healthy and HCV-infected subjects. All HCV-infected subjects were treatment-naïve with HCV RNA ≥ 5 log10 IU/mL. The objectives of the study were to assess safety/tolerability, pharmacokinetics (PK) and antiviral activity.
The trial evaluated single oral doses up to 367 mg (400 mg salt form) in healthy subjects (Part A), single doses up to 550 mg (600 mg salt form) in NC GT-1b HCV-infected subjects (Part B) and multiple doses up to 550 mg once-daily (QD) for 7 days in NC GT-1b HCV-infected subjects (Part C). Ongoing cohorts are evaluating 550 mg QD for 7 days in NC GT-3 (Part D) and Child Pugh A cirrhotic GT-1b/3 (Part E) HCV-infected subjects. Plasma levels of AT-273, the nucleoside metabolite of the active triphosphate, were measured using LC-MS/MS; HCV RNA was quantified using COBAS® AmpliPrep/TaqMan® HCV Test v2.0 with a limit of quantitation (LOQ) of 15 IU/mL.
About AT-527
AT-527, a proprietary investigational agent discovered at Atea, is the salt form of a purine nucleotide prodrug NS5B polymerase inhibitor. Unique structural modifications of AT-527 result in differentiated pharmacologic and antiviral properties as compared to other anti-HCV nucleotides. AT-511, the free base of AT-527, showed potent antiviral activity in vitro against wild-type clinical isolates with EC95 values less than 80 nM in all HCV genotypes, and demonstrated about 10- to 14-fold more potency than sofosbuvir (SOF) in GT-1 and GT-3 replicons. AT-511 maintained activity against SOF-resistant S282T single and S282T/L159F double variants, with about 50-fold greater potency than SOF.
About Hepatitis C
Hepatitis C is a blood-borne infectious disease of the liver and is a leading cause of chronic liver disease and transplants. According to the World Health Organization, over 70 million people suffer from chronic hepatitis C. Direct-acting antiviral agents (DAAs) have markedly improved the prognosis of many patients infected with the hepatitis C virus and allow the achievement of a cure in 8 – 12 weeks in select patient populations. Further shortening of the treatment duration in those patients and extending it to more difficult-to-treat HCV patient populations continues to be a sought-after goal of the biotech and pharma industry. Global sales of DAAs for the treatment of HCV infection were $12.5 billion in 2017.
About Atea
Atea Pharmaceuticals is a clinical stage biopharmaceutical company engaged in the discovery and development of proprietary and novel therapeutics for the treatment of hepatitis C and other single stranded RNA viral infections. Atea was founded in 2013 by its Chairman and Chief Executive Officer Jean-Pierre Sommadossi, PhD, and is headquartered in Boston, MA.
Contact
Company:
Andrea J. Corcoran
617-669-4272
[email protected]
Investors and Media:
Constantine Davides
Westwicke Partners
Tel: 339-970-2846
[email protected]
The post Atea Pharmaceuticals reports positive proof of concept clinical data with AT-527 for the treatment of chronic Hepatitis C appeared first on Atea Pharmaceuticals.
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