Gesynta Pharma Begins Phase 2 Trial of Vipoglanstat for Endometriosis

Gesynta Pharma AB has announced that the first patient has been dosed in its Phase 2 clinical trial evaluating vipoglanstat, a novel non-hormonal and non-opioid drug candidate for treating endometriosis.

The study marks an important step toward developing new treatment options for the approximately 190 million women worldwide living with this chronic inflammatory condition, which is a leading cause of infertility.

Inside the NOVA Phase 2 Trial

The study, known as the NOVA trial, is a randomized, double-blind, placebo-controlled Phase 2 proof-of-concept trial designed to evaluate the safety and effectiveness of vipoglanstat.

Key trial details include:

• Approximately 190 women aged 18–45 will be enrolled
• Conducted across seven European countries
• Participants will receive either vipoglanstat or placebo
• Treatment will be administered orally for four menstrual cycles

Countries participating in the study include:

• United Kingdom
• Italy
• Poland
• Romania
• Bulgaria
• Czech Republic
• Hungary

The trial will evaluate two different doses of vipoglanstat and provide key dosing data to support future clinical development.

Top-line results are expected in 2027.

What the Trial Will Measure?

The primary objective of the NOVA trial is to determine whether vipoglanstat can reduce endometriosis-related pain during non-menstrual days. Secondary endpoints include evaluating the drug’s impact on:

• Period pain (dysmenorrhea)
• Pain during sexual intercourse (dyspareunia)
• Use of opioid rescue medication
• Quality-of-life outcomes

Researchers will also assess endometriotic lesions using MRI imaging as an exploratory endpoint.

How Vipoglanstat Works?

Vipoglanstat targets mPGES-1, an enzyme involved in the production of prostaglandin E2 (PGE2), a pro-inflammatory mediator strongly linked to endometriosis-related pain and inflammation.

Preclinical research suggests that inhibiting this pathway may:

• Reduce pain-related symptoms
• Decrease the size and number of endometriotic lesions

Earlier clinical studies have also demonstrated favorable safety, tolerability, and pharmacodynamic profiles, supporting further development of the drug.

Expert Perspective on the Study

Christian Becker, Professor of Reproductive Sciences and Co-Director of the Oxford Endometriosis Care Centre, is serving as the international coordinating investigator for the NOVA trial.

According to Becker, many patients continue to experience persistent pain and reduced quality of life despite current treatments.

He noted that evaluating new approaches like vipoglanstat could help expand therapeutic options for patients with the disease.

Company Outlook on the Trial

Patric Stenberg, CEO of Gesynta Pharma, described dosing the first patient as a major milestone for the company.

He highlighted that the therapy could potentially become a “game-changer” in endometriosis treatment by delivering meaningful improvements in pain relief and overall quality of life for women with moderate to severe disease.

Understanding Endometriosis

Endometriosis is a chronic inflammatory condition in which tissue similar to the uterine lining grows outside the uterus, usually within the pelvic cavity.

The disease can cause:

• Severe menstrual pain
• Chronic pelvic pain
• Pain during intercourse
• Gastrointestinal symptoms
• Infertility

Although it affects about 10% of women of reproductive age, endometriosis is often underdiagnosed and undertreated, leaving many patients with limited treatment options.

Current therapies typically include:

• Pain medications
• Hormonal treatments
• Surgical interventions

However, these approaches may not provide long-term relief for many patients.

Gesynta Pharma’s Pipeline

Gesynta Pharma AB is developing therapies targeting mPGES-1, an enzyme involved in inflammatory processes.

The company’s pipeline includes:

• Vipoglanstat – currently in Phase 2 development for endometriosis
• GS-073 – preparing to enter Phase 1 trials for chronic inflammatory pain

The company’s research originated at Karolinska Institutet in Sweden and is supported by several international life science investors.

With the NOVA trial now underway, Gesynta aims to advance a new non-hormonal treatment option for women living with endometriosis.

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