Gesynta Pharma has randomised half of the planned patients in its Phase 2 NOVA trial evaluating vipoglanstat as a potential non-hormonal treatment for endometriosis.

The Swedish biotechnology company said 95 of the target 190 participants have now been enrolled in the study, which is being conducted at sites across Europe. Top-line results are expected in 2027.

The NOVA trial is a randomised, double-blind, placebo-controlled Phase 2 proof-of-concept study designed to assess the efficacy and safety of two dose levels of vipoglanstat in women with endometriosis.

The study is intended to support the design of a future Phase 3 development programme if the candidate demonstrates positive results.

Endometriosis affects an estimated one in 10 women of reproductive age and is associated with chronic pain, inflammation and infertility. Despite its prevalence, treatment options remain limited, with many therapies relying on hormonal approaches that may not be suitable for all patients.

Gesynta is developing vipoglanstat as a non-hormonal, non-opioid treatment designed to target microsomal prostaglandin E synthase-1 (mPGES-1), an enzyme involved in the production of prostaglandin E2, a mediator linked to inflammation and pain.

The company believes that selectively inhibiting mPGES-1 could reduce endometriosis-related symptoms while avoiding some of the limitations associated with existing treatment approaches.

Eva Johnsson, chief medical officer and vice president clinical development at Gesynta Pharma, said: “Reaching the halfway point in patient recruitment marks a major milestone for our Phase 2 clinical trial in endometriosis. Achieved well ahead of schedule, the rapid progress reflects strong participation from clinical sites and great interest among eligible participants. This momentum highlights the urgent need for better treatments.”

She added: “We are now eager to complete enrollment and proceed to the next phase of evaluation.”

According to the company, previous clinical studies have demonstrated the safety and tolerability of vipoglanstat and provided evidence of pharmacodynamic activity in humans.

Preclinical studies have also suggested the candidate may reduce both pain-related behaviours and endometriotic lesion burden.

Patric Stenberg, chief executive officer of Gesynta Pharma, said: “The NOVA trial is a significant advancement in a field with few ongoing clinical trials, and a key step toward establishing a strong foundation for a future Phase 3 program for vipoglanstat.”

He added: “Given the immense medical need, our focus remains on delivering a treatment that is highly effective, safe, and well-tolerated.”

Recruitment milestones are not always considered major clinical events, but progress in endometriosis drug development continues to attract attention because of the significant unmet need for effective non-hormonal therapies. The completion of half of the planned enrolment keeps the NOVA study on track as Gesynta prepares for the next stage of clinical evaluation.