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Systemic sclerosis is an aggressive autoimmune disease that can cause serious damage to microvascular vessels.
in the first stage, this can lead to reduced blood flow to the fingers and toes, which in turn causes pain and impairs fine motor function.
later in the disease, patients are at risk of finger ulcers and extreme pain and difficulty healing in finger ulcers and finger and/or toe wounds.
the lungs, kidneys and heart can also be severely damaged due to inflammation of the micro vein system.
pharmaceutical company Gesynta Pharma announced today that its Phase II study of its drug candidate, GS-248, has been selected in the first group of patients and is expected to complete the clinical trial by the end of 2021.
drug GS-248 selectively inhibits the microsome prosthyroid prosthetic enzyme 1 (mPGES-1), which in turn provides anti-inflammatory and vasosal physophageal effects.
Phase I study showed that GS-248 has good pharmacodynamic properties, supports daily dosing, and has strong and long-lasting anti-inflammatory properties (PGE2 reduction) and vascular protection (increased prostocycline).
randomized, placebo-controlled, double-blind Phase II study will include about 80 patients in four European countries.
patients will be oral GS-248 or placebo once a day at a dose of 120 mg for 4 weeks.