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.
Systemic sclerosis is a debilitating autoimmune disease that causes serious damage to the microvasculature. This proof-of-concept study will investigate the safety of GS-248 and its efficacy on Raynaud’s phenomenon and peripheral blood flow in this patient group.
Study results are expected towards the end of 2021 and will provide the basis for future clinical trials both in systemic sclerosis and potentially other chronic inflammatory diseases.
Gesynta Pharma’s drug candidate GS-248 provides a combination of anti-inflammatory and vasodilatory effects by potently and selectively inhibiting microsomal prostaglandin E synthase-1 (mPGES-1), states the company. A Phase I study has demonstrated that GS-248 is safe and well tolerated with a pharmacokinetic profile supporting once daily dosing and with potent and durable anti-inflammatory properties (PGE2 decrease), as well as vasoprotective effects (prostacyclin increase). These results support development of GS-248 as a treatment of systemic sclerosis and a range of other medical conditions, such as cardiovascular diseases and rheumatic diseases, says the company.
“Gesynta Pharma has already shown that GS-248 exerts strong effects on biomarkers of inflammation and vascular protection in humans, and we are excited to now initiate a Phase II study in patients with systemic sclerosis. This is a patient group with a high unmet medical need and results from the present study also have potential to serve as a solid foundation for expanding future clinical development of our first-in-class drug candidate to other chronic inflammatory conditions,” says Gesynta Pharma’s CEO, Patric Stenberg.
About the Phase II study
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 at a dose of 120 mg orally once daily, or placebo, for four weeks. The proof-of-concept study will generate a multitude of safety, efficacy and pharmacokinetic data to support further clinical development in systemic sclerosis and potential additional chronic inflammatory diseases.
Photo of Patric Stenberg: Gesynta Pharma