Metabolite drives activity of Celgene's ozanimod

New data from Celgene Corp. (NASDAQ:CELG) showed that a metabolite of ozanimod accounted for the "majority" of the total activity of the relapsing multiple sclerosis candidate in humans. The revelation may provide a clue as to why FDA issued a refusal to file letter to an NDA for ozanimod in February. According to Celgene, FDA said the non-clinical and clinical pharmacology sections of the NDA were "insufficient to permit a complete review" (see BioCentury, March 2).

In a presentation at the American Academy of Neurology meeting in Los Angeles, Celgene said ozanimod and its major active metabolite, CC112273, showed similar potency and selectivity for ozanimod’s targets, sphingosine 1-phosphate receptor 1 (S1PR1; S1P1; EDG1) and S1PR5. While the metabolite accounted for the majority of the total activity of ozanimod in humans, CC112273 was only a minor metabolite in non-clinical studies in animals, according to a slide in the presentation...