Gesynta Pharma receives orphan drug designation by FDA for systemic sclerosis

pharmafile | April 27, 2022 | News story | Research and Development  

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.

System sclerosis (also known as scleroderma) is a chronic, autoimmune disease that affects, among other things, the body’s smallest vessels, the microvasculature, and is associated with great medical needs due to the current lack of safe and effective medicines.

OX-MPI has a unique and promising mechanism of action with the potential to help both patients with systemic sclerosis and patients with other chronic inflammatory diseases. The drug candidaate is currently being evaluated in a clinical Phase II trial, and data is anticipated in late 2022.

Nikolaj Sørensen, CEO & President of Orexo, commented: “We are very pleased with the progress Gesynta Pharma has made with our former OX-MPI (GS-248) project. Obtaining orphan drug status in the US, is a true milestone to ensure the pharmaceutical reaches the patients suffering from systemic sclerosis as soon as possible. We are looking forward to see the result of the ongoing Phase II trial later this year. With a successful outcome we are confident Gesynta Pharma, with their experienced and competent management team, are well positioned to develop OX-MPI (GS-248) to a commercial success.”

“The orphan drug designation granted to our drug candidate GS-248 for the treatment of systemic sclerosis provides an opportunity for extended market exclusivity, which is a valuable complement to its strong patent protection. Strengthened by this positive news and our constructive dialogue with the FDA, we continue working towards the goal of being able to offer an effective and safe treatment for patients with systemic sclerosis,” says Patric Stenberg, CEO of Gesynta Pharma.

Lina Adams

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