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 moderately to severely active 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

Over 600 study sites will be participating in the studies, covering 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.

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 sites currently open for recruitment at clinicaltrials.gov.

ABTECT-1 ABTECT-2

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.

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.