Orexo has announced that their partner, Gesynta Pharma has been granted Orphan Drug Designation by the FDA, for OX-MPI (GS248), a drug candidate for the treatment of systemic sclerosis.
Orexo has announced that their partner, Gesynta Pharma has been granted Orphan Drug Designation by the FDA, for OX-MPI (GS248), a drug candidate for the treatment of systemic sclerosis.
Stockholm, Sweden, June 14 2021 – Gesynta Pharma AB today announced that an IND (Investigational New Drug Application) has been submitted to the U.S. Food & Drug Administration for its oral drug candidate GS-248 in patients with systemic sclerosis. Concurrently, more than half of the patients in the ongoing Phase II study in four countries across Europe have been recruited. The study investigates the safety of GS-248 and its efficacy on Raynaud’s phenomenon and peripheral vascular blood flow. Top-line data is expected in Q1/2022.
Gesynta Pharma has announced that the first patients have been dosed in a Phase II study of its oral drug candidate GS-248 in patients with systemic sclerosis.