Gesynta Pharma AB news
Gesynta Pharma AB today announces the decision to advance the development of its clinical-stage drug candidate GS-248 in endometriosis - a chronic inflammatory condition affecting approximately 10 percent of all women of reproductive age. This strategically important decision follows a recent preclinical proof-of-concept study with GS-248 in an advanced model of endometriosis, where disease-modifying properties of the drug candidate were firmly established. These data together with the previo
Gesynta Pharma AB today announces results from an exploratory Phase II study of the candidate drug GS-248 in systemic sclerosis patients. GS-248 was well tolerated, exhibited a favorable safety profile, and elicited a potent systemic inhibition of the target enzyme mPGES-1. However, no significant effects on the patients` symptoms could be demonstrated. For this reason, the company intends to concentrate the continued development of GS-248 in other disease areas, including endometriosi
Gesynta Pharma AB today announces that all patients have been recruited for the company`s clinical Phase II study with the drug candidate GS-248, which is being evaluated as a treatment for the rare disorder systemic sclerosis.The study is intended to demonstrate proof-of-concept and to evaluate the safety profile of GS-248. Top-line data is expected in the fall of 2022.
Systemic sclerosis (also known as scleroderma) is a chronic, autoimmune disease that l
Gesynta Pharma AB today announces that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to the company`s drug candidate GS-248 for the treatment of systemic sclerosis. GS-248 is currently being evaluated in a Phase II clinical trial as a treatment for Raynaud`s phenomenon secondary to systemic sclerosis.
Orphan Drug Designation is intended to encourage the development of drugs for the treatment of rare diseas
Gesynta Pharma AB today 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. The study investigates the safety of GS-248 and its efficacy on Raynaud`s phenomenon and peripheral vascular blood flow. Top-line data is expec