Aligos Reports High Viral Suppression in Phase 1 HBV Study and Impairment PK Data
Aligos Therapeutics presented Phase 1 monotherapy data showing high viral suppression with its potent CAM-E candidate pevifoscorvir sodium in chronic hepatitis B subjects at CROI. It also showcased pharmacokinetic profiles of its ritonavir-free pan-coronavirus protease inhibitor ALG-097558 in participants with hepatic and renal impairment.
1. Positive Phase 1 Data for Pevifoscorvir Sodium
Aligos presented Phase 1 monotherapy results demonstrating high viral suppression in chronic HBV patients treated with pevifoscorvir sodium, a potent CAM-E candidate (Poster #588, Session: Beyond the C: Hepatitis D, B, and E). These data support its potential as a first-/best-in-class small molecule for chronic hepatitis B infection.
2. Pharmacokinetic Profiles of ALG-097558
Data from Poster #737 detailed the pharmacokinetics of ritonavir-free pan-coronavirus protease inhibitor ALG-097558 in participants with hepatic and renal impairment. The study assessed exposure, clearance, and safety across impairment cohorts to inform dosing recommendations.
3. Federal Funding and COVID Program Advancement
The ALG-097558 program is funded in whole or in part by grants from NIAID, NIH, and HHS under Contract No. 75N93023C00052. This support underscores Aligos’ parallel advancement of its COVID-19 therapy program alongside its HBV pipeline.
4. Pipeline Outlook and Next Steps
Aligos plans to leverage these clinical findings to design pivotal trials for its HBV and coronavirus candidates, with additional data readouts and regulatory submissions anticipated later this year.