Gesynta Pharma has reported positive Phase I results with GS-248 for the treatment of microvascular disease.
The Phase I study was designed to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of single oral doses up to 300 mg and multiple once daily doses up to 180 mg for 10 days in healthy male and female subjects.
In summary, GS-248 was safe and well tolerated with a pharmacokinetic profile supporting once daily dosing and with potent and durable effects on relevant anti-inflammatory and vasoprotective biomarkers.
“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,” says Patric Stenberg, CEO of Gesynta Pharma.
The next steps
A Phase II study to investigate the safety and efficacy of GS-248 in Systemic Sclerosis patients is now being planned.
An abstract with the results from the Phase I study has been accepted for presentation at the 2020 EULAR e-congress June 3-6.
GS-248 is a potent and selective inhibitor of microsomal prostaglandin E synthase-1 (mPGES-1) in development for the treatment of microvascular diseases in chronic inflammatory conditions. Preclinical studies demonstrate that inhibition of mPGES-1 provides a combination of antiinflammatory, vasodilatory and platelet inhibitory effects.
The study was conducted in collaboration with Clinical Trial Consultants AB in Uppsala, Sweden.
Image caption: Gesynta Pharma founders (Front left to right: Gunilla Ekström, Charlotte Edenius, Urban Paulsson. Back left to right: Ralf Morgenstern, Per-Johan Jakobsson, Patric Stenberg)