The clinical trial, named NOVA, intends to evaluate the efficacy and safety of vipoglanstat against placebo in approximately 190 patients with endometriosis across several European countries.

The approvals from the UK Medicines and Healthcare products Regulatory Agency (MHRA) and Research Ethics Committee (REC) enable the company to now initiate the Phase 2 study with vipoglanstat in endometriosis, it states.

”In our mission to provide innovative treatments for patients suffering from endometriosis, the approval to begin our Phase 2 clinical trial in the UK is a crucial step for Gesynta Pharma. We look forward to working closely with our UK clinical partners as we continue the development of vipoglanstat,” says Patric Stenberg, CEO of Gesynta Pharma.

The NOVA study

The NOVA (Non-hormonal Option – a Vipoglanstat Assessment trial) study is a Phase 2 clinical trial of vipoglanstat, a novel non-hormonal, non-opioid treatment for endometriosis. This chronic inflammatory disease, affecting one in ten women of reproductive age, can cause intense pain, impaired quality of life, and infertility. Vipoglanstat targets mPGES-1, an enzyme found in endometriotic lesions (tissue similar to the lining of the uterus, growing outside the uterus), with preclinical data demonstrating marked reductions in both pain and lesions.

This clinical proof-of-concept trial is estimated to include approximately 190 patients in several countries across Europe. The trial is designed to evaluate the efficacy and safety of two dose levels of vipoglanstat versus a placebo over a four-month period. This will also provide critical dosage information for future clinical development.