Swedish pharma company Gesynta Pharma has reported positive results from the phase 1 clinical trial of GS-248, which is being developed for the treatment of microvascular diseases in chronic inflammatory conditions.
The purpose of the early-stage clinical trial was to assess the safety, tolerability, pharmacokinetic and pharmacodynamic properties of GS-248 after subjecting healthy subjects to single and multiple ascending doses.
According to Gesynta Pharma, GS-248 was found to be safe and well-tolerated with a pharmacokinetic profile supporting once-daily dosing. The drug candidate has been found to be potent and having durable effects on relevant anti-inflammatory and vasoprotective biomarkers, said the Swedish pharma company.
Gesynta Pharma said that the results of the phase 1 clinical trial lay the foundation for advancing the clinical development of GS-248 in microvascular dysfunction, and paving way for a phase 2 clinical study in patients with systemic sclerosis.
As per the Swedish pharma compay, GS-248 is a potent and selective inhibitor of microsomal prostaglandin E synthase-1 (mPGES-1). Its preclinical studies showed that inhibition of mPGES-1 offers a combination of anti-inflammatory, vasodilatory, and platelet inhibitory effects.
Patric Stenberg – CEO of Gesynta Pharma said: “The results obtained from the Phase I study are very positive for our efforts to develop new effective treatments for microvascular diseases where there still exist large unmet medical needs. The confirmation of strong effects on biomarkers of inflammation and vascular protection in humans demonstrate the potential of GS-248 as a unique treatment of microvascular dysfunction in Systemic Sclerosis and other chronic inflammatory conditions.”