Gesynta Pharma AB, a Swedish clinical stage pharmaceutical company focusing on chronic inflammatory diseases, today announced that 50% of the target of 190 patients have been randomized in its Phase 2 clinical proof-of-concept trial (NOVA). The study is evaluating vipoglanstat, a novel, non-hormonal, non-opioid drug candidate for the treatment of endometriosis. This painful, often debilitating, chronic inflammatory disease, which affects more than 10 % of women in reproductive age, is also a major cause of infertility. Top-line results from the study are expected in 2027.

The NOVA* trial is a randomized, double-blind, placebo-controlled Phase 2 clinical proof-of-concept trial evaluating vipoglanstat in women with endometriosis across Europe. The trial assesses the efficacy and safety of two dose levels of vipoglanstat and will provide important information for the design of a subsequent Phase 3 program.

"Reaching the halfway point in patient recruitment marks a major milestone for our Phase 2 clinical trial in endometriosis. Achieved well ahead of schedule, the rapid progress reflects strong participation from clinical sites and great interest among eligible participants. This momentum highlights the urgent need for better treatments," says Eva Johnsson, Chief Medical Officer (CMO) and VP Clinical Development. "We are now eager to complete enrollment and proceed to the next phase of evaluation."

"The NOVA trial is a significant advancement in a field with few ongoing clinical trials, and a key step toward establishing a strong foundation for a future Phase 3 program for vipoglanstat," comments Patric Stenberg, CEO of Gesynta Pharma. "Given the immense medical need, our focus remains on delivering a treatment that is highly effective, safe, and well-tolerated."

Vipoglanstat is an innovative, orally active drug candidate designed to reduce pain and inflammation by targeting mPGES-1, a key enzyme that produces the proinflammatory mediator prostaglandin E2 (PGE2) in endometriotic lesions. A preclinical proof-of-concept study in an advanced endometriosis model demonstrated that vipoglanstat significantly reduced pain-related behaviors and endometriotic lesion burden. Previous clinical studies confirm its safety, tolerability, and favorable pharmacodynamic effects in humans, supporting further development of the drug candidate as a non-hormonal, non-opioid treatment for endometriosis.

*NOVA: the Non-hormonal Option – a Vipoglanstat Assessment trial