Aligos Therapeutics has stopped dosing of subjects in the first chronic hepatitis B (CHB) group of the Phase I ALG-020572-401 clinical trial of its antisense oligonucleotide drug candidate, ALG-020572.
The company has discontinued the drug development after a participant experienced a serious adverse event (SAE) with a substantial rise in alanine aminotransferase (ALT) indicative of treatment-induced liver toxicity after receiving multiple doses of 210mg ALG-020572.
The treatment resulted in a short-term hospitalisation of the participant.
Furthermore, this is one of four CHB patients in the first cohort who possibly had drug-associated ALT flares.
These events were not anticipated based on previous experience in nonclinical studies as well as single dose safety findings in healthy subjects.
Aligos added that all the four CHB patients showed improvement in laboratory parameters and symptoms and the hospitalised participant was discharged.
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The randomised, double-blind, placebo-controlled Phase I trial was designed to analyse the safety, tolerability, pharmacokinetics and pharmacodynamics of subcutaneous doses of ALG-020572.
Part 1 of the trial was intended to assess single ascending doses of the drug in healthy subjects while multiple doses were analysed in CHB subjects in Part 2 of the trial.
With the latest development, Aligos is reprioritising its pipeline, which comprises savings from discontinuing two clinical development programmes, ALG-010133 and ALG-020572, as well as proceeds from its collaborations and other cost-saving processes.
The funds will be used to progress the ongoing clinical programmes, including ALG-000184 and ALG-055009, and expedite internal oral small molecule development programmes, including a SARS-CoV-2 protease inhibitor among others.
Aligos expects its cash, cash equivalents and investments as of 31 December last year will be adequate to support scheduled operations through the first half of 2024.
Aligos Therapeutics chairman and CEO Lawrence Blatt said: “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.”