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Gesynta Pharma submits an IND to the FDA

Gesynta Pharma has 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, states the company in a press release. 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, states the company.

GS-248

GS-248 provides a combination of anti-inflammatory, vasodilatory and platelet inhibitory effects by potently and selectively inhibiting microsomal prostaglandin E synthase-1 (mPGES-1). The randomized, placebo-controlled, double-blind Phase II study will include approximately 80 patients at clinical sites in four European countries. Patients will receive GS-248 orally once daily, or placebo, for four weeks.

“I am delighted with the response and hard work from our clinical trial team to reach the halfway point of the study recruitment despite of COVID-19, and this has allowed us to confidently submit an IND for the systemic sclerosis indication. Furthermore, we are accelerating research into other indications and are looking forward to announcing results from validation studies in pulmonary hypertension,” says Gesynta Pharma’s CEO, Patric Stenberg.

Photo of Patric Stenberg