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Aligos Discontinues Development of its Antisense Oligonucleotide Drug Candidate ALG-020572 in Subjects with Chronic Hepatitis B and Pivots Internal Strategic Emphasis to its Small Molecule Portfolio
Dosing in the first cohort discontinued after multiple reports of ALT flares suggestive of drug-induced liver toxicity Funds will be redirected to support
About this update from Aligos Therapeutics, Inc.
[{"type":"text","content":"Dosing in the first cohort discontinued after multiple reports of ALT flares suggestive of drug-induced liver toxicity Funds will be redirected to support ongoing clinical programs, including ALG-000184 (Class-II CAM for CHB) and ALG-055009 (THR- agonist for NASH), and to accelerate internal oral small molecule development programs, including a SARS-CoV-2 protease inhibitor, a Class-I CAM for CHB and a PD-L1 inhibitor for CHB SOUTH SAN FRANCISCO, Calif., March 22, 2022 (GLOBE NEWSWIRE) -- Aligos Therapeutics, Inc. (Nasdaq: ALGS), 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 discontinued development of its drug candidate, ALG-020572, which was being studied in subjects with chronic hepatitis B (CHB). Dosing in the first CHB cohort of Study ALG-020572-401 (NCT05001022) was stopped after one subject experienced a serious adverse event (SAE) with significant increase in alanine aminotransferase (ALT) following multiple dosing of 210 mg ALG-020572 that resulted in a brief hospitalization. This is one of four CHB subjects in this first cohort who experienced potentially drug-related ALT flares, which were unexpected based on prior experience in nonclinical studies and single dose safety data in healthy volunteers. In all four CHB subjects, laboratory parameters and symptoms are improving and the hospitalized subject has been discharged. “Patient safety is our number one priority, and we are gratified to see that these unanticipated ALT elevations are improving and subjects are on the path to recovering,” said Lawrence M. Blatt, Ph.D., MBA, Chairman and CEO of Aligos. “We will continue to follow emerging safety and antiviral activity data as these subjects complete their off-treatment follow-up to understand these events further. Although this is undeniably a setback, our team remains committed to developing drug candidates with the potential to improve the lives of patients living with viral and liver diseases. In particular, we will continue to focus on advancing our clinical development programs, including: ALG-000184 (capsid assembly modulator; CAM), which is being dosed orally for 28 days in CHB subjects and is progressing towards longer duration studies aimed at chronic suppression of HBV DNA and RNA;ALG-...