The French biotech company Abivax is preparing for a possible commercialization of its drug candidate ABX464. “Further development of ABX464 and production expansion are proceeding, both with regard to the requirements of phase 3 and in preparation for a potential commercialization as a result of possible positive results of the Covid-19 study,” the company announced. In the planned expansion of production capacities, they are working with the French industrial partners Seqens and Delpharm. 12 million doses of the drug are to be produced in 2021.
The French are also driving development in other areas of indication for ABX464. It is planned to start approval-relevant phase 3 studies with the drug candidate in the treatment of patients with moderate to severe ulcerative colitis and phase 2b / 3 in Crohn’s disease. In the second quarter of next year the results of a clinical phase 2b study with ABX464 for the treatment of ulcerative colitis will be presented. Further phase 1 studies, including one in Japan for the Asian market, should generate additional data in the near future.
“I am confident that the results of the phase 2b study on the treatment of ulcerative colitis and the data from the supplementary phase 1 studies will contribute to a positive exchange with the regulatory authorities and enable us to pave the way for a smooth transition of our lead product candidate towards phase 3 and market approval ”, says Hartmut J. Ehrlich, CEO of Abivax.
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