Clinical trial progress
Search documents
Aligos Therapeutics Provides Phase 2 B-SUPREME Study Progress Updates
Globenewswire· 2026-01-21 13:00
Core Insights - Aligos Therapeutics is progressing with the Phase 2 B-SUPREME study of pevifoscorvir sodium for chronic hepatitis B virus (HBV) infection, with interim analyses scheduled for 2026 [1][2] Study Progress - The Phase 2 B-SUPREME study currently has 144 subjects enrolled globally, with expectations for interim analyses to provide insights on study tracking [2] - The first interim analysis will include approximately 60% (36) of HBeAg- participants who have completed 12 weeks of treatment, expected in the first half of 2026 [3] - A second interim analysis is planned for when about 50% (55) of HBeAg+ participants complete 24 weeks of treatment, anticipated in the second half of 2026 [4] Regulatory Compliance - To maintain study integrity and comply with FDA regulations, the company will remain blinded to subject-level data and will receive insights from the Data Safety Monitoring Board [5] Leadership Update - Hardean Achneck, MD has resigned as Executive Vice President and Chief Medical Officer, and a search for his successor is underway [6] Study Details - The Phase 2 B-SUPREME study is a randomized, double-blind, active-controlled multicenter trial evaluating the safety and efficacy of ALG-000184 monotherapy compared to tenofovir disoproxil fumarate in approximately 200 untreated adult subjects with chronic HBV infection for 48 weeks [7] - The primary endpoint for HBeAg- participants is HBV DNA <LLOQ (10 IU/mL), while for HBeAg+ participants, it is also HBV DNA <LLOQ (10 IU/mL) [7] Product Information - Pevifoscorvir sodium, previously known as ALG-000184, is a potential first-in-class oral small molecule capsid assembly modulator being developed for chronic HBV infection [8] - Phase 1 studies have shown that pevifoscorvir sodium is well-tolerated, with no safety signals and demonstrated linear pharmacokinetics and excellent antiviral activity [8]
ZCMD, ABCL, VOR, IXHL, OVID, BFRG Rally After Hours On Clinical Momentum And Recent Updates
RTTNews· 2025-10-02 05:09
Core Insights - Several biotech and healthcare stocks experienced significant after-hours gains on October 1, driven by technical momentum and recent clinical updates rather than new disclosures [1] Company Summaries - Zhongchao Inc. (ZCMD) saw a 14.04% increase in after-hours trading, rising to $1.30 from $1.14, despite no new filings or press releases [2] - AbCellera Biologics Inc. (ABCL) rose 11.41% in after-hours trading, closing at $6.64, following an 18.49% gain during the regular session, attributed to recent clinical trial progress [3][4] - Vor Biopharma Inc. (VOR) surged 9.53% in after-hours trading, recovering from a 19.42% drop during the regular session, with no new updates since a recent announcement regarding clinical data presentation [5] - Incannex Healthcare Inc. (IXHL) gained 6.48% in after-hours trading, partially recovering from a 6.94% drop, with the latest update showing positive Phase 2 trial results for PSX-001 [6] - Ovid Therapeutics Inc. (OVID) shares rose 8.03% in after-hours trading, building on a 5.38% gain during the regular session, with recent earnings report indicating a narrower net loss and higher revenue [7] - Bullfrog AI Holdings Inc. (BFRG) advanced 3.44% in after-hours trading, following a 3.57% rise during the regular session, after announcing an expansion of its sales and marketing team [8]