MedPath

ABX-464

Generic Name
ABX-464
Drug Type
Small Molecule
Chemical Formula
C16H10ClF3N2O
CAS Number
1258453-75-6
Unique Ingredient Identifier
26RU378B9V
Background

ABX-464 is under investigation in clinical trial NCT03905109 (Safety Evaluation of ABX464 in Patients With Moderate to Severe Active Crohn's Disease).

Clinical Trials
Related News

Abivax Announces KOL Webcast to Discuss Obefazimod Phase 3 Trial in Ulcerative Colitis

• Leading gastroenterologist Dr. David Rubin will provide expert insights on the ulcerative colitis treatment landscape and discuss Abivax's ABTECT Phase 3 trial of obefazimod. • The virtual event, scheduled for March 17, 2025, will explore obefazimod's potential to address unmet medical needs in ulcerative colitis treatment. • Attendees will have the opportunity to engage with Dr. Rubin and Abivax's management team during a live Q&A session following the presentation.

Abivax's ABX464 Shows Promise in Reducing HIV Viral Reservoirs in Phase 2a Trial

• French biotech Abivax reports significant breakthrough as their drug ABX464 achieves up to 52% reduction in HIV DNA levels during 28-day treatment in phase 2a trial. • Extended 12-week study with lower dosage demonstrates HIV DNA reduction up to 85% in some patients, marking first evidence of ABX464's ability to impact both blood and rectal tissue viral reservoirs. • The treatment shows potential for complete virus elimination and long-term viral load control, with favorable safety profile supporting extended dosing regimens.

Abivax's Obefazimod Phase 3 Trials Show Strong Progress in Ulcerative Colitis Treatment

• Abivax's Phase 3 trials for obefazimod in ulcerative colitis are progressing well, with over 80% enrollment, suggesting timely completion and results expected in Q3 2025. • Strategic trial design, including an 8-week primary endpoint and exclusion of certain immunomodulators, aims to minimize placebo response and maximize success potential. • Analysts maintain a Buy rating for Abivax, supported by the company's solid financial position and the potential of obefazimod as an effective treatment option. • Patient characteristics in the Phase 3 trials are consistent with previous studies, enhancing confidence in replicating successful Phase 2b results.

Abivax's Phase 3 Ulcerative Colitis Trial Nears Completion with 82% Enrollment

• Abivax's ABTECT Phase 3 trial for obefazimod in ulcerative colitis has reached 82% enrollment, with 1,003 of 1,224 participants now recruited. • Top-line results from the 8-week induction phase are expected in Q3 2025, while 44-week maintenance data is anticipated in Q2 2026. • A New Drug Application (NDA) submission is planned for the second half of 2026, contingent on positive clinical outcomes from the trial. • Abivax reports sufficient cash runway to cover the ABTECT induction trial readout and operations into Q4 2025.

Abivax's Phase 2b Trial of Obefazimod for Crohn's Disease Enrolls First Patient

• Abivax has initiated its Phase 2b ENHANCE-CD trial, with the first patient enrolled to evaluate obefazimod in Crohn's disease. • The trial is a multicenter, double-blind, randomized, placebo-controlled study assessing the efficacy and safety of once-daily obefazimod in adults. • The study includes a 12-week induction phase, a 40-week maintenance phase, and a 48-week extension phase to assess long-term safety. • Obefazimod, an oral small molecule, aims to stabilize the immune response by enhancing miR-124 expression, offering a convenient treatment option.

Abivax's Phase 3 ABTECT Trial for Ulcerative Colitis Reaches Enrollment Milestone

• Abivax's Phase 3 ABTECT trial, evaluating obefazimod for ulcerative colitis, has surpassed 600 patients enrolled, marking a significant milestone. • The trial is on track to achieve full enrollment in early Q1 2025, reinforcing the company's timeline for this pivotal study. • Baseline characteristics of participants align with observations from the Phase 2b trial, suggesting consistency in patient population. • Obefazimod, an oral small molecule, aims to enhance miR-124 expression and is also planned for a Phase 2b trial in Crohn's disease.
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