MedPath

Abivax S.A.

🇫🇷France
Ownership
-
Employees
61
Market Cap
$752.4M
Website
Introduction

Abivax SA engages in the sale, research, distribution, and development of biopharmaceutical products. It offers commercial and development products of anti-viral compounds and human vaccines. The commercialized products include vaccines for typhoid fever, meningococcus, and leptospirosis. The products under development include vaccines for chronic hepatitis B, ebola, and dengue virus. The company was founded by Philippe Pouletty on December 4, 2003 and is headquartered in Paris, France.

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 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.

Bioxodes Advances BIOX-101 for Intracerebral Hemorrhage Treatment with New Funding and Clinical Milestones

• Bioxodes secured €2.7 million in Series A extension funding to advance BIOX-101, a novel therapy for intracerebral hemorrhage (ICH). • The funding supports the completion of the BIRCH Phase 2a trial and preparations for a Phase 2b trial of BIOX-101 in ICH. • Interim data from the BIRCH Phase 2a trial, evaluating BIOX-101 in ICH patients, is expected in Q1 2025. • BIOX-101, derived from tick saliva, aims to reduce secondary brain injuries post-hemorrhagic stroke by preventing clot formation and neuroinflammation.

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.

Tulisokibart Shows Promise in Treating Moderate to Severe Ulcerative Colitis

• A Phase 2 trial of tulisokibart, an anti-TL1A monoclonal antibody, demonstrated superior efficacy compared to placebo in inducing clinical remission in patients with moderate to severe ulcerative colitis. • The study utilized a genetic-based diagnostic test to identify patients more likely to respond to tulisokibart, showing improved remission rates in this subgroup. • Tulisokibart modulates inflammation and the body's anti-inflammatory mechanisms, offering a novel approach compared to existing IBD treatments that can exacerbate inflammation. • The safety profile of tulisokibart appeared comparable to placebo, with similar rates of adverse events, supporting its potential as a valuable new 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.
© Copyright 2025. All Rights Reserved by MedPath