A new phase 2 trial of a novel, non-hormonal treatment for endometriosis is underway, with Gesynta Pharma dosing the first patient with vipoglanstat. The NOVA study moves the candidate into mid-stage testing in a field ripe for new therapeutic options that avoid the side effects of hormone-based treatments.
Inside the NOVA trial
The randomised, double-blind, placebo-controlled trial will enrol around 190 women aged 18 to 45 across seven European countries, including the UK, Italy and Poland. Participants will receive one of two oral doses of vipoglanstat or a placebo for approximately four menstrual cycles, with topline data expected in 2027. The primary endpoint is reduction in non-menstrual endometriosis pain, while secondary and exploratory endpoints include dysmenorrhoea, dyspareunia, opioid rescue use, quality-of-life scores, and MRI-based lesion assessments.
Targeting inflammation without hormones
Christian Becker, Professor of Reproductive Sciences and Co-Director, Oxford Endometriosis CaRe Centre, who is serving as international coordinating investigator, said the start of dosing marked “an important step toward expanding therapeutic options for women living with endometriosis”. He added that many patients still experience “persistent pain and impaired daily functioning” despite existing hormonal and surgical care, which “underscores the need for new approaches”.
In terms of the science, vipoglanstat works by blocking mPGES-1, an enzyme that drives the production of prostaglandin E2 in endometriotic lesions and fuels both inflammation and pain. In a preclinical proof-of-concept study, the drug reduced “pain-related behaviour” and shrank lesion load. Earlier human studies have also shown a favourable safety and tolerability profile alongside clear pharmacodynamic effects, according to Gesynta.
Race for non-hormonal therapies
In the wider landscape, other phase 2 studies are exploring non-hormonal approaches to treating endometriosis pain, as companies look beyond GnRH antagonists and broad-spectrum hormone suppression, which remain the current standard of care. A positive result for Gesynta could help validate mPGES-1 as a pathway for new treatment strategies – ones that do not induce menopausal side effects or reduce fertility.
Patric Stenberg, CEO, Gesynta Pharma, said: “Dosing the first patient in the NOVA trial signifies a major milestone in the development of vipoglanstat, with the aim of providing a game-changing treatment for endometriosis.” He added that the study is designed to yield “robust, controlled data on pain relief and quality of life for women with moderate to severe disease”.
Long-standing unmet need
This will likely be welcome news for a community that has long called for new treatment options for a disease that, on average, takes seven to 10 years to be formally diagnosed. While endometriosis R&D activity has increased over the past five years, only a handful of drugs have reached the market, and most still rely on hormonal control – leaving clear headroom for targeted anti-inflammatory and disease-modifying agents such as vipoglanstat.
