A New Way To Potentially Address Inflammation

Abivax’s lead product candidate obefazimod is currently in Phase 3 clinical trials for the treatment of moderately to severely active ulcerative colitis (“ABTECT program”).

1,200 UC patients across 36 countries in over 600 study sites will take part in the pivotal Phase 3 program that covers North America, Europe, Latin America, and Asia Pacific.

ABTECT Global Clinical Trial Program

The pivotal Phase 3 program consists of two induction trials and a single subsequent maintenance trial.

Obefazimod - An oral option with a unique mechanism of action that stabilizes inflammatory pathways simultaneously

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.

Phase 3 Induction Studies in Ulcerative Colitis

The first patient was enrolled in the US on Oct. 11, 2022, and the inclusion of patients in the induction studies ABTECT-1 (ABX464-105) and ABTECT-2 (ABX464-106) is ongoing.

Primary Endpoint: Clinical remission vs. placebo at week 8.

More Information

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

Primary Endpoint: Clinical remission vs. placebo at 52 weeks (which is week 44 of the maintenance trial).

More Information

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

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 your treating physician or gastroenterologist who will be able to provide further guidance.