Mirum Pharmaceuticals, Incyte Say Zilurgisertib Showed Meaningful Reductions in Heterotopic Ossification Lesion Volume During Clinical Trial

MT Newswires Live06-15

Mirum Pharmaceuticals (MIRM) and Incyte (INCY) said Sunday their threapeutic candidate for fibrodysplasia ossificans progressiva, zilurgisertib, demonstrated positive results during a phase 2 study.

The product showed meaningful reductions in total heterotopic ossification, or HO, lesion volume and no new HO lesions and flare activity in adolescents and adults with fibrodysplasia ossificans progressiva.

The companies said the US Food and Drug Administration has accepted the new drug application and granted priority review for zilurgisertib as a treatment for fibrodysplasia ossificans progressiva in patients 12 years and older.

The Prescription Drug User Fee Act target date for the product is Sept. 26, according to the companies.

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