Gesynta Pharma -Model GS-248 -Advanced Drug Candidate
GS-248 is Gesynta Pharma’s most advanced drug candidate, currently in clinical development as a potential treatment of systemic sclerosis. Recent clinical phase I data in healthy individuals show that GS-248 potently inhibits the production of PGE2 in a tolerable and safe manner, while increasing the observed levels of protective and vasodilatory prostacyclin by two to three times. The study data also show that a once-daily oral dose is sufficient to maintain the therapeutic effect over 24 hours, which enables a convenient and patient-friendly administration.
Gesynta Pharma is currently conducting a placebo-controlled clinical study in order to document the safety and efficacy profile of GS-248 during a four-week-treatment in circa 80 patients. The participants have been diagnosed with systemic sclerosis and exhibit recurrent Raynaud’s phenomenon. The study is primarily tracking patients’ symptoms, including the frequency of Raynaud attacks, but also documenting digital blood flow as well as inflammatory biomarkers. The study, which is conducted in four European countries, is coordinated by the University of Manchester Centre for Musculoskeletal Research. Initial study results are expected in early 2022. The results will contribute with important insights not only for the continued development of GS-248 in systemic sclerosis, but also for its potential development in other inflammatory diseases.
Provided a satisfactory outcome of the current study, Gesynta will move forward with a clinical Phase IIb study to further document the efficacy of GS-248 in reducing the incidence of Raynaud’s phenomenon as well as digital ulcers in patients with systemic sclerosis. Following a satisfactory Phase IIb study, the company will seek the optimum solution to bring GS-248 to regulatory approval and launch. This can be done by the company alone, or together with a strategic partner.