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First Aligos drug candidate to commence clinical trials
First-in-human trial marks ~2.5-year path from company formation to entry into the clinic
SOUTH SAN FRANCISCO, Calif., Aug. 18, 2020 (GLOBE NEWSWIRE) -- Aligos Therapeutics, Inc. (Aligos), a private clinical stage biopharmaceutical company focused on developing novel therapeutics to address unmet medical needs in viral and liver diseases, including chronic hepatitis B (CHB) and coronaviruses and therapeutics for nonalcoholic steatohepatitis (NASH), today announced that it has dosed its first subject in a first-in-human Phase 1a/b trial. This trial will evaluate ALG-010133, a proprietary oligonucleotide S-antigen transport-inhibiting oligonucleotide polymer (STOPSTM) molecule that functions to decrease viral S-antigen (or HBsAg) levels, an essential step for enabling functional cure in CHB.
“This marks an important milestone for the company, as ALG-010133 is Aligos’ first asset to enter into clinical trials since the company’s launch in 2018,” said Lawrence Blatt, Ph.D., MBA, Chief Executive Officer of Aligos. “Our team has spent the last two years discovering and optimizing STOPS molecules, which ultimately led to the identification and advancement of ALG-010133. We believe that this drug candidate has the potential to significantly suppress HBsAg levels in patients with CHB and are excited to initiate this important proof of concept trial.”
ALG-010133-101 (NCT04485663) is a multi-part umbrella trial that will evaluate the safety, pharmacokinetics and antiviral activity of up to 12 weekly doses of subcutaneously administered ALG-010133 in healthy volunteers and virologically suppressed patients with CHB. Initially, Aligos is conducting the trial at a single clinical pharmacology unit in Auckland, New Zealand, and, once dosing in CHB patients starts, at multiple investigational sites across the Asia-Pacific region and Europe. Aligos expects to report topline CHB results for certain trial cohorts beginning in the second half of 2021.
Aligos’ STOPS program is one of several programs in its CHB portfolio that target different clinically validated mechanisms of action. The portfolio also includes capsid assembly modulator (CAM), antisense oligonucleotide (ASO), and small interfering RNA (siRNA) drug candidates. All of these drug candidates have properties that indicate that they could be used in combinations to develop potentially best-in-class treatment regimens that may achieve higher rates of functional cure than current standard of care. For each of these drug candidates, Aligos plans to initially establish proof of concept as monotherapy in Phase 1 umbrella trials before evaluating them in combination in subsequent trials.
“Approved treatments, such as nucleos(t)ide analogs, result in low rates of functional cure and require lifelong therapy for the approximately 290 million people living with CHB around the world,” noted Matthew McClure, M.D., Chief Medical Officer. “A key part of our mission at Aligos is to improve this rate by advancing multiple drug candidates, each of which interrupts distinct steps in the viral life cycle, that will act additively or synergistically when combined. This trial is a first step in our effort to achieve that mission.”
About Aligos
Aligos Therapeutics, Inc., is a privately held, clinical stage biopharmaceutical company that was founded in 2018 with the mission to become a world leader in the treatment of viral infections and liver diseases. Aligos is focused on the development of targeted antiviral therapies for chronic hepatitis B (CHB) and coronaviruses as well as leveraging its expertise in liver diseases to create targeted therapeutics for nonalcoholic steatohepatitis (NASH). Aligos’ strategy is to harness the deep expertise and decades of drug development experience its workforce has in liver disease, particularly viral hepatitis, to rapidly advance its pipeline of potentially best-in-class molecules.
Please visit www.aligos.com for more information.
Media Contact
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LifeSci Communications
+1 315 879 8192
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LifeSci Advisors
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发表于 2020-8-19 15:56
