Abivax‘s Clinical Trials

Abivax is currently conducting its pivotal Phase 3 clinical trials to test the safety and efficacy of its lead product candidate, obefazimod, in moderately to severely active ulcerative colitis.

Phase 2a and 2b clinical trials have successfully been conducted with obefazimod for the treatment of ulcerative colitis (UC).

While Abivax has decided not to pursue additional clinical work in rheumatoid arthritis (RA) at this point, a Phase 2a clinical trial has also been completed for the treatment of RA, where Abivax saw encouraging proof-of-concept data supporting obefazimod’s potential role in addressing inflammatory conditions beyond IBD.

Further, Abivax has completed four Phase 1 clinical trials to assess the tolerability and safety profile of obefazimod, the results of which we believe provides supportive data for our further clinical development and New Drug Application submission for obefazimod.

ABTECT Program UC

ABTECT Induction Studies UC

ABTECT Maintenance Study UC

Clinical Phase 3 Program in UC

1,200 UC patients across 36 countries will take part in the pivotal Phase 3 clinical trials that consists of two induction studies (ABTECT-1 (ABX464-105) and ABTECT-2 (ABX464-106)) and a single subsequent maintenance study (ABTECT maintenance trial (ABX464-107)).

These three pivotal studies are all randomized, double-blind, and placebo controlled, using independent and central review of video-taped endoscopies. The primary efficacy endpoint, assessed at week 8 in the induction and at week 44 in the maintenance study, will be clinical remission according to the Modified Mayo Score, as recommended by the FDA.

In consultation with international regulators, including the FDA, EMA, PMDA and CDE, obefazimod 25mg and 50mg will be investigated in the ABTECT program for the treatment of UC in patients with moderately to severely active UC.

Over 600 trial sites will be participating in the studies, covering North America, Europe, Latin America and Asia Pacific.

Phase 3 Induction Studies in Ulcerative Colitis

The inclusion of patients in the induction studies ABTECT-1 (ABX464-105) and ABTECT-2 (ABX464-106) is ongoing.

More information

You can find more information on the countries and the study centers currently open for recruitment at clinicaltrials.gov.

clinicaltrials.gov

Phase 3 Maintenance Study in Ulcerative Colitis

Only patients who conclude the induction phase of one of the two induction studies have the possibility to roll over into the ABTECT maintenance trial (ABX464-107), where long-term effects of the treatment are evaluated.

Important Information

Please note that the drug candidate obefazimod is at present in the clinical testing stage and subject to the regulations set by the competent authorities.

Abivax is legally not entitled to decide whether a patient is eligible to be included in the clinical trials that Abivax sponsors. The investigating physicians of the clinical study centers are the sole individuals competent for deciding whether a patient is eligible, according to the inclusion and exclusion criteria defined in the corresponding clinical study protocol.

Additionally, Abivax cannot communicate or interact with individual patients on the conduct or progress of the study. You will find all publicly available information at clinicaltrials.gov.