Patients with moderate to severe ulcerative colitis (UC) can now be enrolled onto two phase 3 induction studies for a biotech company’s lead candidate drug.
France-based Abivax SA is a phase 3 clinical stage biotech company that focuses on developing therapies that modulate the immune system to treat chronic inflammatory diseases, viral infections, and cancer.
It received approval from the central U.S. Institutional Review Board (IRB) for the protocols for the studies.
This allows the initiation of enrollment with obefazimod (ABX464) in UC in the U.S. A first-patient-in is anticipated for the end of the third quarter of this year.
Hartmut Ehrlich, CEO of Abivax, said: “We are very pleased with the U.S. IRB approval of the phase 3 induction protocols to confirm efficacy and safety of obefazimod in adults with moderate to severe ulcerative colitis. Enrolment of patients can be initiated for the two induction studies and subsequently for the maintenance trial. Patients and caregivers urgently need alternative therapeutic options for the treatment of ulcerative colitis.
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