Gesynta Pharma Completes NOVA Trial Enrollment Ahead of Schedule

STOCKHOLM, Oct. 20, 2026 /CourierPR/ -- Gesynta Pharma AB, a clinical-stage biotech company, has completed enrollment in its Phase 2 NOVA trial, a randomized, double-blind, placebo-controlled study evaluating vipoglanstat, a novel, non-hormonal, non-opioid drug candidate for endometriosis. The company announced that the trial, which was designed to assess the efficacy and safety of two dose levels of vipoglanstat, reached full enrollment with 213 patients randomized against the original target of 190, ahead of schedule by more than three months.

The NOVA trial, which is being conducted across multiple sites in Europe, is a proof-of-concept and dose-finding study. It aims to evaluate the drug candidate in women with endometriosis and is expected to generate key data for the design of a subsequent 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. 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.

The NOVA trial, which is expected to provide top-line results in the second quarter of 2027, will assess the efficacy of vipoglanstat on endometriosis-related pain during non-menstrual days, menstrual pain (dysmenorrhea), pain during sexual intercourse (dyspareunia), use of opioid rescue medication, and quality-of-life measures. Changes in endometriotic lesions assessed by MRI will also be explored.

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 have shown full target engagement, robust pharmacokinetics, and a favorable safety and tolerability profile, supporting the potential of vipoglanstat as a transformative treatment for endometriosis.

Gesynta Pharma is backed by a highly experienced team with extensive drug development expertise, leading scientific and clinical advisors, and an international investor base spanning European life science and US women's health specialists. The company's lead program, vipoglanstat, is intended for long-term use and is designed to target pain, inflammation, and lesion development through selective inhibition of mPGES-1. Preclinical studies have demonstrated strong and sustained pain relief, together with a 70% reduction in endometriotic lesions in an advanced disease model.