Gesynta Pharma has announced that the first patient has been dosed in its Phase 2 NOVA trial of vipoglanstat, a novel non-hormonal, non-opioid therapy for endometriosis.
The trial marks a critical step toward new treatment options for the estimated 190 million women worldwide affected by this often debilitating condition and a leading cause of infertility.
The NOVA trial is a randomized, double-blind, placebo-controlled Phase 2 proof-of-concept study. It will test two doses of vipoglanstat against placebo and gather key dosing information for future development.
Around 190 women aged 18 to 45 across the UK, Italy, Poland, Romania, Bulgaria, the Czech Republic, and Hungary will participate. Participants will receive the drug or placebo orally for roughly four menstrual cycles.
The trial’s primary goal is to evaluate vipoglanstat’s effect on endometriosis-related pain during non-menstrual days. Secondary endpoints include period pain (dysmenorrhea), pain during sexual intercourse (dyspareunia), use of opioid rescue medication, and quality-of-life improvements. MRI assessments will explore changes in endometriotic lesions. 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,” said Christian Becker, Co-Director of the Oxford Endometriosis CaRe Centre, and International Coordinating Investigator for NOVA.
Vipoglanstat targets mPGES-1, an enzyme that produces the proinflammatory mediator prostaglandin E2 (PGE2) in endometriotic lesions. Preclinical studies in advanced endometriosis models showed significant reductions in pain-related behaviors and lesion load.
Earlier clinical trials have confirmed its safety, tolerability, and pharmacodynamic effects in humans, paving the way for this Phase 2 study.
“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,” said Patric Stenberg, CEO of Gesynta Pharma.
Endometriosis is a chronic inflammatory disorder in which tissue similar to the uterine lining grows outside the uterus, mainly in the pelvic cavity. It causes inflammation, fibrosis, and the formation of lesions and adhesions, often presenting with severe period pain, chronic pelvic pain, pain during sex, gastrointestinal symptoms, and infertility. Current treatments include analgesics, hormonal therapies, and surgery.
