Gesynta Pharma has dosed the first patient in its Phase II trial, NOVA, investigating vipoglanstat, a non-hormonal, non-opioid drug for treating endometriosis.
The clinical proof-of-concept study seeks to address the needs of the nearly 190 million women affected by this chronic inflammatory disease globally.
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This double-blind, placebo-controlled, randomised trial will assess two doses of vipoglanstat compared to a placebo. It will establish the safety and efficacy profile along with dose information for future studies.
NOVA plans to enrol around 190 women aged 18 to 45 years across various European regions.
Participants will take either vipoglanstat or a placebo orally over four menstrual cycles. Efficacy will primarily be measured by the reduction in endometriosis-related pain during non-menstrual days.
Secondary objectives cover pain during sexual intercourse (dyspareunia), period pain (dysmenorrhoea), use of opioid rescue medication, and patient response to a quality-of-life scale.
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By GlobalDataThe study will also explore changes in endometriotic lesion load via magnetic resonance imaging (MRI). Top line results are anticipated in 2027.
Vipoglanstat inhibits microsomal prostaglandin E synthase-1 (mPGES-1), an enzyme involved in producing prostaglandin E2 (PGE2) within endometriotic lesions.
Previous preclinical studies demonstrated a significant decrease in both pain-related behaviours and lesion load. Prior clinical investigations indicated that vipoglanstat is safe and well-tolerated in humans.
Gesynta Pharma CEO Patric Stenberg said: “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.
“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.”
