Gesynta Pharma administers first dose in Phase II NOVA trial.

Gesynta Pharma has begun dosing the first participant in its Phase II NOVA trial to test vipoglanstat, a novel non-hormonal, non-opioid therapy for endometriosis, aiming to reduce pain and improve quality of life for women affected by this chronic condition.

Gesynta Pharma has initiated dosing of the first participant in its Phase II clinical study, NOVA, which is designed to evaluate vipoglanstat, a new non-hormonal, non-opioid therapy for endometriosis. This trial addresses the needs of an estimated 190 million women worldwide who are affected by this chronic inflammatory disease.

Study Design and Goals

The NOVA study is conducted as a double-blind, placebo-controlled, randomized trial. It will assess two different doses of vipoglanstat compared with a placebo to determine safety, effectiveness, and the appropriate dose for further research.

• Population: Around 190 women, aged 18 to 45, from multiple European countries will participate in the study.
• Intervention: Participants will receive either vipoglanstat or a placebo orally over four menstrual cycles.
• Primary Endpoint: Reduction in endometriosis-related pain on non-menstrual days.
• Secondary Endpoints:
  • Pain during sexual intercourse (dyspareunia)
  • Menstrual pain (dysmenorrhoea)
  • Use of opioid rescue medication
  • Patient-reported outcomes on a quality-of-life scale
• Exploratory Assessments: Evaluation of changes in endometriotic lesion size using magnetic resonance imaging (MRI).

The trial is expected to report initial top-line results by 2027.

Mechanism of Action and Preclinical Evidence

Vipoglanstat works by inhibiting microsomal prostaglandin E synthase-1 (mPGES-1), the enzyme responsible for generating prostaglandin E2 (PGE2) within endometriotic lesions. Preclinical research demonstrated that vipoglanstat significantly reduced both pain behaviors and lesion burden. Earlier clinical assessments confirmed the drug is safe and well-tolerated in humans, supporting the advancement to this Phase II study.

Statements from Gesynta Pharma

Patric Stenberg, CEO of Gesynta Pharma, stated that dosing the first patient in the NOVA trial is a key milestone in the development of vipoglanstat. He highlighted that the study is designed to provide controlled, high-quality evidence regarding pain reduction and quality-of-life improvements for women experiencing moderate to severe endometriosis. With encouraging preclinical data and prior clinical outcomes demonstrating safety, tolerability, and pharmacokinetics, the NOVA study aims to generate valuable insights for future treatment options.

Sources:

• Gesynta Pharma Press Release
• BioSpace
• Fierce Biotech
• Gesynta Pharma doses first patient in Phase II NOVA trial

Author: Olivia Parker
Olivia Parker is a journalist and editor with over 8 years in media. She focuses on culture, arts, and social issues, skilled in feature writing and critical reviews.