Gesynta Pharma has announced that an IND (Investigational New Drug Application) has been submitted to the U.S. Food & Drug Administration (FDA) 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 the first quarter of 2022.
Coordinating Investigator Professor Ariane Herrick, The University of Manchester Centre for Musculoskeletal Research commented: “Systemic sclerosis is a chronic, autoimmune disease that leads to serious damage to the micro vessels and which is associated with great unmet need. In the first stage, attacks of Raynaud’s phenomenon occur, often followed by painful and difficult-to-heal digital ulcers (ulcers of the fingers and toes). The lungs, kidneys and heart can also be severely impaired as a result of the inflammation and damage in the micro vessels. GS-248 has a promising mode of action which could bring relief to both patients with systemic sclerosis and with other chronic inflammatory diseases.”
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 randomised, 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,” said Gesynta Pharma’s CEO, Patric Stenberg.