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.
*NOVA: the Non-hormonal Option - a Vipoglanstat Assessment trial
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ClinicalTrials.gov: https://clinicaltrials.gov/study/NCT07260669
Gesynta Pharma bases its R&D on groundbreaking research from the Karolinska Institutet.
The members of Gesynta Pharma's management team and board of directors have extensive experience from drug development and commercialization.
Endometriosis is a chronic, inflammatory, estrogen-dependent disease affecting millions of women worldwide.
Our lead drug candidate vipoglanstat is in clinical phase 2 for endometriosis, while GS-073 is ready to enter clinical phase 1 for chronic inflammatory pain.