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Vipoglanstat trial reaches recruitment halfway point

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Vipoglanstat has reached the halfway point for patient recruitment in a phase 2 endometriosis trial.

Gesynta Pharma said 50 per cent of the target of 190 patients have been randomised in the NOVA trial.

The study is evaluating vipoglanstat, described by the company as a novel, non-hormonal, non-opioid drug candidate for the treatment of endometriosis.

Endometriosis is a chronic inflammatory condition where tissue similar to the lining of the womb grows outside the uterus, often causing severe pain and, in some cases, infertility.

The condition affects more than 10 per cent of women of reproductive age.

Top-line results from the study are expected in 2027.

The NOVA trial is a randomised, double-blind, placebo-controlled phase 2 proof-of-concept study evaluating vipoglanstat in women with endometriosis across Europe.

This means patients are assigned to treatment groups by chance, neither participants nor researchers know who receives the drug or placebo during the study, and the results are intended to show whether the treatment has enough evidence to move into later testing.

The trial is assessing the efficacy and safety of two dose levels of vipoglanstat and will provide information for the design of a subsequent phase 3 programme.

Eva Johnsson, chief medical officer and vice president of clinical development at Gesynta Pharma, said:

“Reaching the halfway point in patient recruitment marks a major milestone for our Phase 2 clinical trial in endometriosis. Achieved well ahead of schedule, the rapid progress reflects strong participation from clinical sites and great interest among eligible participants. This momentum highlights the urgent need for better treatments.

“We are now eager to complete enrolment and proceed to the next phase of evaluation.”

Patric Stenberg, chief executive of Gesynta Pharma, said:

“The NOVA trial is a significant advancement in a field with few ongoing clinical trials, and a key step toward establishing a strong foundation for a future Phase 3 programme for vipoglanstat.

“Given the immense medical need, our focus remains on delivering a treatment that is highly effective, safe, and well-tolerated.”

Vipoglanstat is an orally active drug candidate designed to reduce pain and inflammation by targeting mPGES-1, an enzyme that produces prostaglandin E2, a substance linked to inflammation in endometriotic lesions.

A preclinical proof-of-concept study in an advanced endometriosis model found that vipoglanstat significantly reduced pain-related behaviours and endometriotic lesion burden.

Gesynta said previous clinical studies have supported the drug candidate’s safety, tolerability and pharmacodynamic effects in humans. Pharmacodynamic effects refer to how a drug acts in the body.

NOVA stands for the Non-hormonal Option, a Vipoglanstat Assessment trial.

Endometriosis commonly presents with severe period pain, known as dysmenorrhoea, pain between periods, pain during sexual intercourse, gastrointestinal symptoms and infertility.

Current management is typically limited to painkillers, hormonal therapies and surgery.

Despite its prevalence, Gesynta said endometriosis remains a critically underserved area of women’s health.

The company said the disease is significantly underdiagnosed and undertreated, with few new treatment options available to patients.

Approximately 190 patients aged 18 to 45 will receive vipoglanstat or placebo over four menstrual cycles.

The primary objective is to evaluate the effect of vipoglanstat on endometriosis-related pain during non-menstrual days.

Secondary objectives include assessing the effect on menstrual pain, known as dysmenorrhoea, pain during sexual intercourse, known as dyspareunia, use of opioid rescue medication and quality-of-life measures.

Changes in endometriotic lesions, areas of tissue linked to the condition, will also be explored using MRI scans.

Gesynta Pharma said its research on targeting mPGES-1 began at Karolinska Institutet in Sweden.

The company said a second drug candidate, GS-073, is ready to enter clinical phase 1 for the treatment of chronic inflammatory pain.

Gesynta Pharma’s shareholders include Hadean Ventures, Industrifonden, Innovestor Life Science, Linc, HealthCap, XGen Venture and other specialist investors.

Entrepreneur

Onto Health acquires diagnostics software company Levy Health

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Onto Health has acquired Levy Health, a fertility software company providing precision diagnostics and patient intake for reproductive medicine.

The acquisition, fuelled by Onto Health’s US$20m Series A fundraise in April, supports its plan to build scalable, tech-enabled infrastructure for reproductive medicine.

Onto founder Roohi Jeelani, MD, called it the first of several moves in the company’s expansion strategy in a LinkedIn post, adding that there was “more coming soon”.

She said: “This isn’t just an acquisition, it’s proof of how we’re building Onto: physician-led, tech-enabled, and built to scale without losing the personal touch fertility patients deserve.”

Headquartered in Chicago, Onto Health combines evidence-based fertility care with artificial intelligence-driven diagnostics, clinical automation and longevity science.

AI-driven diagnostics use software to analyse patient information and support clinical decision-making, rather than replace clinicians.

Levy Health, founded in Berlin with US offices in San Francisco, helps medical providers identify endocrine disorders more quickly and helps clinics streamline fertility workups.

Endocrine disorders affect the body’s hormone system, which can influence ovulation, menstrual cycles and fertility.

Co-founder Caroline Mitterdorfer said joining Onto would expand Levy Health’s fertility care tools to more clinics and patients, helping physicians focus on patient care.

Onto opened its first clinic in Chicago in February, with plans for three more in the greater Chicago area.

The company said in April that it would use its new funding, led by Artis and Humania, to support additional operations in the US and expand into the Gulf Cooperation Council.

The Gulf Cooperation Council includes six Arab states bordering the Persian Gulf.

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Insight

Softening ovaries could extend fertility as women age, study suggests

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Softening ageing ovaries could help women remain fertile for longer, early animal research suggests.

Fertility declines with age for several reasons, including poorer egg quality, fewer ovarian follicles and the gradual stiffening of ovarian tissue.

Existing fertility treatments, including hormone therapy and in vitro fertilisation, mainly address hormonal imbalances or help eggs mature or become fertilised.

Scientists are now examining whether changing the physical structure of the ovaries could provide another route for future fertility treatments.

Stuart A. Cook, of the Cardiovascular and Metabolic Disorders Programme at Duke-National University of Singapore Medical School, published an accompanying commentary on the research.

Researchers led by Shixuan Wang at Huazhong University of Science and Technology in Wuhan, China, collected healthy ovarian tissue from younger, middle-aged and older women.

They also examined samples from patients with polycystic ovary syndrome, known as PCOS, premature ovarian insufficiency, or POI, and endometriosis.

PCOS is a hormonal condition that can disrupt ovulation. POI occurs when the ovaries stop working normally before the age of 40, while endometriosis causes tissue similar to the womb lining to grow elsewhere in the body.

Tests of protein levels and gene activity found higher levels of the inflammatory protein interleukin-11, or IL-11, in ageing and diseased ovaries.

In laboratory experiments, the researchers exposed ovarian fibroblasts to IL-11. Fibroblasts are cells that produce connective tissue.

The protein caused the cells to produce excess collagen, a structural material that can build up during scarring and make tissue stiffer.

The researchers then genetically modified mice so they could not respond to IL-11. The animals developed less ovarian stiffening and maintained better ovarian function as they aged.

Similar results were seen in mouse models of PCOS and POI caused by chemotherapy.

In the final part of the experiment, older mice and rats were injected with a nanoparticle treatment containing small interfering RNA, or siRNA, designed to switch off IL-11.

The treatment made the animals’ ovaries less stiff and improved fertility.

Pregnancy rates among older mice rose from 25 per cent to 50 per cent, while average litter sizes also increased.

More rats treated with the therapy became pregnant and produced larger litters.

The approach remains highly speculative and will require considerably more research before its safety or effectiveness in women can be established.

However, the researchers said blocking the inflammatory pathway could eventually form the basis of new fertility treatments.

They said: “We propose that anti-IL-11 therapy represents a promising translational strategy for delaying ovarian ageing.”

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Entrepreneur

Applications open for the third W Accelerate with Merck KGaA and M Ventures

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W Group has opened applications for W Accelerate with Merck KGaA and M Ventures, inviting reproductive and maternal health startups, scaleups and spinouts to pitch for direct access to global pharma partnership and strategic investment.

Selected companies will pitch on 5th October, competing for the chance to accelerate their growth through commercial partnerships, investment, or both.

This is the third time Merck KGaA, a global leader in reproductive health, has partnered with W Group on the programme, which exists to close the innovation and investment gap in women’s health by connecting the sector’s most promising startups directly with the corporates and investors positioned to scale them.

What Merck KGaA and M Ventures are looking for

This year’s call is focused on breakthrough solutions in female infertility, fertility preservation, adenomyosis, endometriosis, polyendocrine metabolic ovarian syndrome (PMOS), ovarian insufficiency, preeclampsia and pregnancy comorbidities.

New for this round, applicants choose between three pathways depending on what they need from the programme:

  • The Partnership Lane, for companies seeking commercial collaborations and strategic relationships
  • The Investment Lane, for founders looking to connect with investors and secure funding to scale
  • The Dual Lane, for innovators pursuing both partnership and investment opportunities

How the Accelerate event works

Selected companies get a 1:1 pitch practice session ahead of time, then a private 30-minute session with Merck KGaA and M Ventures leadership on the day itself, small-group sessions with regulatory and investment strategy experts, an “Ask Merck Anything” roundtable, and a VIP networking reception.

Key dates

  • Open call launches: 8th July
  • Open call closes: 2nd September
  • Notification of successful companies: 11th September
  • Pitch day: 5th October

Applications are open now at wplatform.typeform.com/to/KGzviBQM.

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