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Aligos Therapeutics Submits Clinical Trial Application for Chronic Hepatitis B Capsid Assembly Modulator Candidate ALG-000184Second drug candidate from Aligos’ CHB portfolio advances towards clinical trial

SOUTH SAN FRANCISCO, Calif., Aug. 24, 2020 (GLOBE NEWSWIRE) — Aligos Therapeutics, Inc. (Aligos), a clinical stage biopharmaceutical company focused on developing novel therapeutics to address unmet medical needs in viral and liver diseases, today announced that it has submitted a clinical trial application (CTA) to the New Zealand Medicines and Medical Devices Safety Authority for a first-in-human Phase 1a/b proof-of-concept trial (ALG-000184-201). The trial is evaluating ALG-000184, a small molecule class II capsid assembly modulator (CAM) that targets hepatitis B virus (HBV) capsid assembly as well as the regulation and transcription of covalently closed circular DNA (cccDNA).

“This is a significant achievement for Aligos Therapeutics,” said Lawrence Blatt, Ph.D., MBA, Chief Executive Officer of Aligos. “Starting with novel CAM compounds discovered in Dr. Raymond Schinazi’s laboratory at Emory University, our teams have collaborated over the last 2 years to further improve upon the CAM technology. This work culminated in the discovery of ALG-000184, which has optimized pharmacokinetic properties and sub-nanomolar potency. ALG-000184 appears to be the most potent class II CAM drug candidate known to have entered clinical development to date and we are excited to see how its enhanced properties translate in clinical trials.”

ALG-000184-201 is a multipart Phase 1a/1b umbrella trial that will evaluate the safety, pharmacokinetics and antiviral activity of up to 28 days of once-daily doses of orally administered ALG-000184 in healthy volunteers and patients with chronic hepatitis B (CHB). “We aim to follow our Phase 1 STOPSTM candidate into the clinic with ALG-000184 and conduct concurrent Phase 1 trials with each of these drug candidates before moving them into combination trials,” noted Matthew McClure, M.D., Chief Medical Officer of Aligos. “We believe that by advancing a purpose-built combination of therapeutics with additive or synergistic antiviral activity, we may be able to significantly improve upon the low rates of functional cure seen with current standard of care medications.”

Aligos’ CAM program is one of four classes of compounds in its CHB development portfolio, which also includes STOPS (S-antigen Transport-inhibiting Oligonucleotide Polymers), antisense oligonucleotide (ASO), and small interfering RNA (siRNA) drug candidates.

About Chronic Hepatitis B (CHB)

CHB is a major cause of chronic liver disease that the World Health Organization estimates affects ~257 million people worldwide, more people than hepatitis C virus (HCV) and HIV infection combined. Serious complications of CHB include cirrhosis and liver cancer, which are associated with significant mortality.  Approximately 900,000 people died from CHB-related causes in 2015 alone and the mortality rate has been rising for decades. Although current standard of care for patients with CHB is effective in suppressing HBV, it is associated with very low rates of functional cure, which is the main goal of CHB treatment.

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.

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