Gesynta Pharma starts Phase 2 trial for novel endometriosis treatment

SWEDEN—Swiss clinical-stage pharmaceutical company Gesynta Pharma AB has dosed the first patient in its Phase 2 clinical trial evaluating vipoglanstat, a non-hormonal, non-opioid drug candidate designed to treat endometriosis.

This milestone advances the search for new therapeutic options for approximately 190 million women worldwide who live with this painful, chronic inflammatory condition that frequently causes infertility.

Understanding the NOVA trial design

The NOVA trial operates as a randomized, double-blind, placebo-controlled study that will assess vipoglanstat’s efficacy and safety.

Researchers plan to enroll approximately 190 women aged 18 to 45 across seven European countries, including the UK, Italy, Poland, Romania, Bulgaria, the Czech Republic, and Hungary.

Participants will receive either vipoglanstat or placebo orally for approximately four menstrual cycles.

The trial will compare two different doses of vipoglanstat against placebo while gathering crucial dosing information to guide future clinical development.

 Top-line results are expected in 2027.

Measuring pain relief and quality of life

The study’s primary objective focuses on evaluating vipoglanstat’s effectiveness in reducing endometriosis-related pain during non-menstrual days.

Secondary objectives examine the drug’s impact on period pain, pain during sexual intercourse, opioid rescue medication usage, and overall quality of life through standardized assessment scales.

Researchers will also use MRI assessments to evaluate endometriotic lesions as an exploratory endpoint.

Christian Becker, Professor of Reproductive Sciences and Co-Director of the Oxford Endometriosis CaRe Centre, serves as International Coordinating Investigator for the trial.

He emphasized that this development represents an important step toward expanding therapeutic options for women with endometriosis.

Despite existing treatments, many patients continue experiencing persistent pain and impaired daily functioning, highlighting the urgent need for new approaches.

Becker expressed enthusiasm about collaborating with Gesynta to determine whether vipoglanstat can deliver meaningful and lasting improvements for patients.

How Vipoglanstat works

The drug candidate targets mPGES-1, a key enzyme responsible for producing prostaglandin E2 (PGE2), a proinflammatory mediator found in endometriotic lesions.

Preclinical proof-of-concept studies using advanced endometriosis models demonstrated that vipoglanstat significantly reduced pain-related behaviors and decreased endometriotic lesion load.

Previous clinical studies have confirmed the drug’s safety, tolerability, and pharmacodynamic effects in humans, supporting its continued development.

Patric Stenberg, CEO of Gesynta Pharma, described dosing the first patient as a major milestone in developing a potential game-changer for endometriosis treatment.

He noted that the trial builds on solid preclinical foundations and positive clinical data regarding safety, tolerability, and pharmacokinetics.

The study aims to provide robust, controlled evidence on pain relief and quality of life improvements for women living with moderate to severe endometriosis.