Gesynta Pharma has completed recruitment for its Phase 2 trial of vipoglanstat in endometriosis, with results expected in the second quarter of 2027.

The NOVA trial has randomised 213 participants, exceeding its original target of 190 and completing enrolment more than three months ahead of schedule. The placebo-controlled study is evaluating two doses of vipoglanstat, an investigational oral treatment designed to reduce pain and inflammation without affecting hormone levels.

Endometriosis occurs when tissue similar to the lining of the uterus grows outside the uterus, potentially causing pain, inflammation and fertility problems. Current treatments include hormonal medicines and surgery, but some patients continue to experience symptoms or cannot tolerate existing therapies.

Trial will assess two doses of vipoglanstat

NOVA is a randomised, double-blind, placebo-controlled Phase 2 proof-of-concept and dose-finding trial involving women with endometriosis at multiple sites across Europe.

The study is designed to assess the efficacy and safety of two dose levels of vipoglanstat. Its results will help inform the design of a potential Phase 3 programme.

Patric Stenberg, chief executive officer of 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.”

Stenberg added: “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.”

The recruitment milestone does not provide evidence that vipoglanstat is effective. The trial’s clinical results will be needed to assess whether the treatment improves symptoms compared with placebo.

Non-hormonal approach targets inflammation

Vipoglanstat is designed to selectively inhibit microsomal prostaglandin E synthase-1 (mPGES-1), an enzyme involved in producing prostaglandin E2 (PGE2), which contributes to inflammation and pain.

By targeting this pathway, Gesynta aims to develop a non-hormonal alternative to treatments that can affect hormone levels. The company is also developing vipoglanstat as a non-opioid treatment, although its potential benefits and risks will need to be established through clinical trials.

Christian Becker, professor of reproductive sciences, co-director of the Oxford Endometriosis CaRe Centre and international coordinating investigator for NOVA, said: “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.”

Preclinical findings preceded Phase 2 study

According to Gesynta, vipoglanstat reduced pain-related behaviours and endometriotic lesion burden in a preclinical proof-of-concept study using an endometriosis model. The release does not identify the animal species used.

The company also reports that clinical studies to date have shown the drug to be well tolerated, with no safety signals, and demonstrated inhibition of the target enzyme. Further data will be needed to establish its safety and efficacy in women with endometriosis.

Topline results from NOVA are expected in Q2 2027 and will help determine the next steps in vipoglanstat’s clinical development.