Orexo’s Partner Gesynta Pharma announces progresses in phase II study of OX-MPI and submits IND with FDA

Uppsala, Sweden – Juni 14, 2021 – Orexo’s partner, Gesynta Pharma, today announces that more than half of the patients in the ongoing phase II study of the drug candidate OX-MPI (GS-248) have been recruited. Gesynta Pharma, who owns all the rights to OX-MPI (GS-248), aims to develop a treatment for systemic sclerosis. Top-line data is expected in Q1 2022. In parallel an IND (Investigational New Drug Application) has been submitted to the US Food & Drug Administration (FDA).

Systemic sclerosis, a debilitating autoimmune disease that causes serious damage to the Microvasculature. The purpose of this study is to investigate the safety of OX-MPI (GS-248) and its efficacy on Raynaud’s phenomenon and peripheral blood flow in the patient group. The study includes approximately 80 patients and the results will serve as a basis for future clinical trials in systemic sclerosis and potentially other inflammatory diseases.

For more information, please read Gesynta Pharma´s press release which is attached.