Gesynta Pharma AB, a clinical-stage biotech company developing vipoglanstat, a non-hormonal, non-opioid therapy that could transform the standard of care for women with endometriosis, today announced that it has completed enrollment in NOVA*, its Phase 2 clinical proof-of-concept and dose-finding trial. With 213 patients randomized against the original target of 190, the trial reached full enrollment more than three months ahead of schedule.

NOVA is a randomized, double-blind, placebo-controlled Phase 2 clinical proof-of-concept trial evaluating vipoglanstat in women with endometriosis across multiple sites in Europe. The study is designed to assess the efficacy and safety of two dose levels of vipoglanstat and will generate key data for the design of a subsequent Phase 3 program.

Patric Stenberg, Chief Executive Officer at Gesynta Pharma, said: “Completing enrollment in NOVA ahead of schedule is an important milestone for Gesynta. We believe the non-hormonal profile of vipoglanstat has been a strong contributing factor to the robust recruitment, resonating with both investigators and patients. Most importantly, it brings us a step closer to offering women with endometriosis a much-needed new treatment option. We look forward to completing the trial and reporting top-line results in the second quarter of 2027, to further inform the design of a Phase 3 program.”

Vipoglanstat is a novel, non-hormonal, non-opioid oral drug, designed to reduce pain and inflammation by selectively inhibiting mPGES-1, a key enzyme responsible for producing prostaglandin E2 (PGE₂), a major driver of inflammation, pain, and lesion growth in endometriosis. By targeting mPGES-1, vipoglanstat has the potential to offer a differentiated treatment approach while addressing the limitations of current therapies, such as menopause-like side effects, treatment duration restrictions and impacts on fertility.

Christian Becker, Professor of Reproductive Sciences, Co-Director of the Oxford Endometriosis CaRe Centre, and International Coordinating Investigator for the NOVA trial, commented: “For women living with endometriosis, pain and other symptoms can have a profound impact on daily life and wellbeing. Many continue to experience significant symptoms despite existing treatments, highlighting the need for new, non-hormonal therapeutic approaches. We look forward to seeing the clinical results next year and what they could mean for patients.”

In a preclinical proof-of-concept study using an advanced endometriosis model, vipoglanstat demonstrated a significant reduction in both pain-related behaviors and endometriotic lesion burden. Clinical studies to date have shown vipoglanstat to be well tolerated with no safety signals, and to fully inhibit the target enzyme, supporting its continued development as a novel, non-hormonal, non-opioid treatment for endometriosis.