Swedish clinical-stage pharmaceutical company Gesynta Pharma AB announced on Wednesday that the first patient has been dosed in its its Phase 2 clinical proof-of-concept trial of vipoglanstat, a novel non-hormonal, non-opioid drug candidate for endometriosis.

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 randomised, 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 dosing information for future clinical development.

Approximately 190 women aged 18 to 45 will take part in the trial across the UK, Italy, Poland, Romania, Bulgaria, Czechia, 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.