Aligos Therapeutics Receives Clinical Trial Application Approval for Chronic Hepatitis B Capsid Assembly Modulator Candidate ALG-000184
Second drug candidate from Aligos’ CHB portfolio cleared to start first-in-human clinical trial
SOUTH SAN FRANCISCO, Calif. September 28, 2020 – 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 the Company has received approval for a clinical trial application (CTA) for a first-in-human Phase 1a/b proof-of-concept clinical trial. Aligos may now commence study ALG-000184-201 (NCT04536337) to evaluate ALG-000184, a small molecule class II capsid assembly modulator (CAM) that targets hepatitis B virus (HBV) capsid assembly as well as the establishment of covalently closed circular DNA (cccDNA). ALG-000184 is the second of Aligos’ chronic hepatitis B (CHB) drug candidates cleared to begin clinical trials.
“In collaboration with Emory University, we have utilized our small molecule chemistry expertise to identify multiple promising CAMs including ALG-000184, which has been optimized for potency as well as other pharmacokinetic properties,” said Lawrence Blatt, Ph.D., MBA, Chief Executive Officer of Aligos. “We look forward to determining how these properties translate in the clinic towards development of novel therapies for patients with chronic hepatitis B.”
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 (1a) and patients with CHB (1b).
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) molecules, 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 affects over 290 million people worldwide. 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 associated with HBV-related liver cancer continues to increase. 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 goal for future CHB treatments.
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.
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