Swedish clinical-stage pharmaceutical company Gesynta Pharma AB announced on Wednesday that 50% of the target of 190 patients have been randomised 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 of reproductive age, is also a major cause of infertility. Top-line results from the study are expected in 2027.

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

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. Gesynta Pharma says that a preclinical proof-of-concept study in an advanced endometriosis model demonstrated that vipoglanstat significantly reduced pain-related behaviours and endometriotic lesion burden. Previous clinical studies confirmed its safety, tolerability, and favourable pharmacodynamic effects in humans, supporting further development of the drug candidate as a non-hormonal, non-opioid treatment for endometriosis.