Sweden-based Gesynta Pharma has dosed the first patient in its Phase 2 clinical proof-of-concept trial (NOVA) of vipoglanstat, a novel non-hormonal, non-opioid drug candidate for endometriosis – adding another non-hormonal therapeutic to the growing endometriosis pipeline.
Vipoglanstat targets mPGES-1, a key enzyme that produces the proinflammatory mediator prostaglandin E2 (PGE2) in endometriotic lesions. A preclinical proof-of-concept study using an advanced endometriosis model showed that the drug significantly reduced both pain-related behaviors and endometriotic lesion load – meaning it may address the underlying disease, not just symptoms.
The NOVA trial is a randomized, double-blind, placebo-controlled study that will enroll approximately 190 women aged 18 to 45 across 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 primary endpoint is efficacy on endometriosis-related pain during non-menstrual days, with secondary endpoints including period pain, pain during intercourse, opioid rescue medication use, and quality of life. Endometriotic lesions will also be evaluated via MRI as an exploratory endpoint. Top-line results are expected in 2027.
“This is an important step toward expanding therapeutic options for women living with endometriosis,” said Christian Becker, Professor of Reproductive Sciences, co-director of the Oxford Endometriosis CaRe Centre, and international coordinating investigator for the trial. “Despite existing treatments, many patients continue to experience persistent pain and impaired daily functioning, underscoring the need for new approaches.”
“Dosing the first patient in the NOVA trial signifies a major milestone in developing vipoglanstat, aiming at providing a game-changer in the treatment of endometriosis,” said CEO Patric Stenberg. “With a solid preclinical basis and positive clinical data on safety, tolerability, and pharmacokinetics, this trial aims to provide robust, controlled data on pain relief and quality of life for women with moderate to severe disease.”
