Gesynta Pharma AB today announced that the first patient has been dosed in its Phase 2 clinical proof-of-concept trial (NOVA) of vipoglanstat, a novel non-hormonal, non-opioid drug candidate for endometriosis. This milestone marks an important step toward a new treatment for the approximately 190 million women worldwide living with this painful, often debilitating, chronic inflammatory condition, which is also a major cause of infertility.

The NOVA* trial is a randomized, double-blind, placebo-controlled Phase 2 clinical proof-of-concept trial of vipoglanstat. NOVA will evaluate the efficacy and safety of two different doses of vipoglanstat compared with placebo and will also provide valuable dosing information for future clinical development.

The trial 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, administered orally, for approximately four menstrual cycles. The primary objective is to evaluate the efficacy of vipoglanstat on endometriosis-related pain during non-menstrual days. Secondary objectives include evaluating the effect of vipoglanstat on period pain (dysmenorrhea), pain during sexual intercourse (dyspareunia), use of opioid rescue medication, and response to a quality-of-life assessment scale. Additionally, endometriotic lesions will be evaluated as an exploratory endpoint using MRI assessments. Top-line results are expected in 2027.

"This is an important step toward expanding therapeutic options for women living with endometriosis. Despite existing treatments, many patients continue to experience persistent pain and impaired daily functioning, underscoring the need for new approaches. I am excited to work with Gesynta to assess whether vipoglanstat can deliver meaningful, lasting improvements for patients," says Christian Becker, Professor of Reproductive Sciences, Co-Director of the Oxford Endometriosis CaRe Centre, and International Coordinating Investigator for the NOVA trial.

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 vipoglanstat significantly reduced pain-related behaviors and endometriotic lesion load. Previous clinical studies confirm its safety, tolerability, and pharmacodynamic effects in humans, supporting further development of vipoglanstat for endometriosis.

"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. 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," says Patric Stenberg, CEO of Gesynta Pharma. 

*NOVA: the Non-hormonal Option - a Vipoglanstat Assessment trial

Read the full press release here: First patient dosed in Gesynta Pharma's endometriosis trial of vipoglanstat