Gesynta Pharma AB news

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.

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.

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

Gesynta Pharma AB today 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 - 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

Gesynta Pharma AB ("Gesynta"), a clinical stage company developing novel anti-inflammatory agents, today announced that the results from the successfully completed First-in-Human clinical study with its lead candidate GS-248 for the treatment of microvascular disease have been presented at the EULAR 2020 E-Congress. Following these results, Gesynta now intends to commence a Phase II study in patients with Systemic Sclerosis.

Gesynta Pharma AB ("Gesynta") announces the completion and positive results of a first clinical study with GS-248. The purpose of the study was to evaluate safety, tolerability, pharmacokinetic and pharmacodynamic properties of GS-248 after single and multiple ascending doses to healthy subjects. The results support the further clinical development of GS-248 in microvascular dysfunction and a Phase II clinical study in patients with Systemic Sclerosis is being planned. An abstract with

Gesynta Pharma AB ("Gesynta") announces that the first clinical study with GS-248 has been initiated and that the first healthy volunteers have been dosed. The purpose of the phase I study is to study safety, tolerability and pharmacokinetic properties of GS-248 as well as its effect on relevant biomarkers.