Gesynta Pharma Initiates Phase II Trial of Non-Hormonal Endometriosis Treatment Vipoglanstat
Key Insights
Gesynta Pharma (search) has dosed the first patient in its Phase II NOVA trial investigating vipoglanstat, a non-hormonal, non-opioid drug for treating endometriosis (search).
The double-blind, placebo-controlled study will enroll approximately 190 women aged 18-45 across European regions to evaluate two doses of vipoglanstat against placebo over four menstrual cycles.
Vipoglanstat targets microsomal prostaglandin E synthase-1 (search) (mPGES-1), an enzyme involved in producing prostaglandin E2 within endometriotic lesions, with topline results expected in 2027.
Gesynta Pharma (search) has dosed the first patient in its Phase II NOVA trial, marking a significant milestone in the development of vipoglanstat, a novel non-hormonal, non-opioid treatment for endometriosis (search). The clinical proof-of-concept study seeks to address the needs of nearly 190 million women affected by this chronic inflammatory disease globally.
Trial Design and Patient Population
The NOVA trial is a double-blind, placebo-controlled, randomized study that will assess two doses of vipoglanstat compared to placebo. The trial plans to enroll approximately 190 women aged 18 to 45 years across various European regions. Participants will take either vipoglanstat or placebo orally over four menstrual cycles.
The study will establish the safety and efficacy profile of vipoglanstat along with dose information for future studies. Topline results are anticipated in 2027.
Primary and Secondary Endpoints
Efficacy will primarily be measured by the reduction in endometriosis (search)-related pain during non-menstrual days. Secondary objectives include evaluating pain during sexual intercourse (dyspareunia), period pain (dysmenorrhoea), use of opioid rescue medication, and patient response to a quality-of-life scale.
The study will also explore changes in endometriotic lesion load via magnetic resonance imaging (MRI), providing additional insights into the drug's therapeutic effects.
Mechanism of Action and Preclinical Data
Vipoglanstat inhibits microsomal prostaglandin E synthase-1 (search) (mPGES-1), an enzyme involved in producing prostaglandin E2 (PGE2) within endometriotic lesions. Previous preclinical studies demonstrated a significant decrease in both pain-related behaviors and lesion load. Prior clinical investigations indicated that vipoglanstat is safe and well-tolerated in humans.
Company Perspective
"Dosing the first patient in the NOVA trial signifies a major milestone in developing vipoglanstat, aiming at providing a game-changer in the treatment of endometriosis (search)," said Gesynta Pharma (search) CEO Patric Stenberg. "With a solid preclinical basis and positive clinical data on safety, tolerability, and pharmacokinetics, this trial aims to provide robust, controlled data on pain relief and quality of life for women with moderate to severe disease."