ABTECT

Phase 3 clinical program for the treatment of ulcerative colitis

Abivax’s lead product candidate obefazimod is currently in Phase 3 clinical trials for the treatment of ulcerative colitis (“ABTECT program”) with the first patient enrolled in the United States in October 2022.

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

ABTECT Global Clinical Trial Program

600 clinical trial sites are expected to participate in the ABTECT program, which are located in the regions North America, Europe, Latin America and Asia Pacific.

About Obefazimod

ABTECT Induction Trials

ABTECT Maintenance Trial

Obefazimod - A small molecule with anti-inflammatory properties

Abivax believes obefazimod is a highly differentiated oral drug candidate, with a novel mechanism of action based on the upregulation of a single microRNA (miR-124) with potent anti-inflammatory properties. Obefazimod was observed to exert its anti-inflammatory effects in Phase 2a and Phase 2b clinical induction and maintenance trials which were conducted in patients suffering from ulcerative colitis.

Obefazimod Mechanism of Action

Watch our animation video to learn more about obefazimod's mechanism of action.

ABTECT-1 and ABTECT-2 Induction Trials

The two induction trials ABTECT-1 and ABTECT-2 are randomized, double-blind, and placebo controlled, using independent, blinded review of the videotaped endoscopies. The primary efficacy endpoint is clinical remission according to the modified Mayo Score, assessed at week 8 during the induction treatment.

In consultation with international regulators, including both the FDA and EMA, obefazimod 25mg and 50mg will be investigated in the ABTECT program for the treatment of UC in advanced therapies (AT) naïve and in AT-failure patients.

More Information

More information on the induction trials
ABTECT-1
(ABX464-105: NCT05507203 - EU CT 2022-500535-36) and

ABTECT-2
(ABX464-106: NCT05507216 - EU CT 2022-500536-11)
at clinicaltrials.gov:

ABTECT-1 ABTECT-2

ABTECT Maintenance Trial

Patients who completed one of the induction trials have the possibility to continue their treatment in the subsequent maintenance trial to evaluate the long-term safety and efficacy of obefazimod.

The primary efficacy endpoint is clinical remission according to the modified Mayo Score, assessed at week 44 during the maintenance treatment.

More Information

More information on the ABTECT maintenance trial (ABX464-107: NCT05535946 - EU CT 2022-500537-84) at clinicaltrials.gov:

ABTECT-Maintenance

Learn more

To check the current status of the trials of our ABTECT program, the list of clinical trial sites open for recruitment and for further information, please visit clinicaltrials.gov where you will find all relevant details on the induction studies ABTECT-1 and ABTECT-2 as well as on the ABTECT maintenance trial.

If you are a healthcare professional and interested in further information, please send an email to ABTECT@abivax.com.

If you are a patient and potentially interested in participating in the ABTECT program, please talk to you treating physician or gastroenterologist who will be able to provide further guidance.