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.

A weight loss jab may improve fertility outcomes in women with PMOS, early findings from an ongoing clinical trial suggest.

The proof-of-concept analysis found that injectable semaglutide may offer reproductive benefits while also addressing obesity and metabolic dysfunction.

It is the first report to examine how injectable semaglutide may improve reproductive outcomes in women with PMOS while also addressing obesity and metabolic dysfunction.

The work forms part of the ongoing RESTORE clinical trial.

Melanie Cree, professor at CU Anschutz and first author of the report, said: “Women with PMOS frequently face a frustrating choice between treatments that target reproductive symptoms and those that address metabolic health.

“Our early findings suggest injectable semaglutide may have the potential to improve both, offering a more comprehensive approach to care.

“This medication is incredibly promising when someone responds with 10 per cent weight loss.”

The trial is examining whether semaglutide can restore ovulation and improve reproductive health in adolescents and adults with polyendocrine metabolic ovarian syndrome, known as PMOS.

PMOS, formerly known as polycystic ovary syndrome or PCOS, is a hormone and metabolic condition linked to irregular periods, raised testosterone levels, infertility risk, obesity and increased cardiometabolic disease.

Cardiometabolic disease refers to conditions linked to the heart and metabolism, such as heart disease, high blood pressure and type 2 diabetes.

Existing treatments, including metformin and hormonal contraceptives, often do not fully address reproductive and metabolic complications at the same time.

The analysis focused on participants aged 12 to 35 who lost at least 10 per cent of their body weight during treatment.

Researchers said reproductive improvements appeared earlier than expected, prompting them to report preliminary findings while the wider study continues.

Cree is also a paediatric endocrinologist at Children’s Hospital Colorado.

Endocrinologists are doctors who specialise in hormones and hormone-related conditions.

Cree said: “What makes this work particularly important is that it focuses specifically on women with PMOS receiving injectable semaglutide.

“Although GLP-1 medications have transformed obesity treatment, there remains a significant need for rigorous data examining how these therapies affect fertility and reproductive function in this population.”

The RESTORE study is evaluating semaglutide treatment in girls and women with PMOS and obesity.

Its broader aim is to determine whether weight loss and metabolic improvements can restore ovulation and improve reproductive outcomes.

Ovulation is the release of an egg from the ovary, a key part of the menstrual cycle and fertility.

The authors said the findings are from an early proof-of-concept analysis and that larger, longer-term studies will be needed to confirm whether the reproductive benefits last.

The findings suggest injectable semaglutide may become a treatment option for women with PMOS seeking improvements in both metabolic and reproductive health, if future studies confirm the results.

Peers have called for law reform after two House of Lords debates on fertility treatment, surrogacy, embryo research and declining birthrates.

The first debate was put forward by crossbench peer Baroness Ruth Deech, who previously chaired the UK’s fertility regulator, the Human Fertilisation and Embryology Authority.

She discussed proposals from the HFEA to reform the Human Fertilisation and Embryology Act, along with proposals from the Scottish Law Commission and the Law Commission of England and Wales to reform the Surrogacy Arrangements Act.

She called for parliamentary scrutiny of possible changes to regulatory powers, consent rules, donor information and future scientific developments.

Baroness Deech said: “Parliament should plan by setting up a Select Committee to examine the HFEA’s proposals to expand regulatory powers, simplify consent rules, modernise donor information provisions and create a flexible framework for future scientific developments.”

Former fertility professionals were among those contributing to the debate.

Professor Lord Robert Winston, a Labour peer who founded the IVF service at Hammersmith Hospital in London, said: “Infertility is not a disease; it is actually a symptom of something wrong.”

Professor Baroness Geeta Nargund, a Labour peer, current HFEA member and former medical director of CREATE Fertility, disagreed.

She said: “Infertility is a disease, as stated by the World Health Organisation.”

Liberal Democrat peer Baroness Caroline Pidgeon highlighted regional differences in access to NHS-funded fertility treatment.

She cited figures from the Progress Educational Trust’s NHS Fertility Funding Tracker showing that only two of England’s 42 integrated care boards comply with the recently updated fertility guideline published by the National Institute for Health and Care Excellence.

Integrated care boards are local NHS organisations responsible for planning and funding healthcare services in their areas.

Baroness Pidgeon said many boards were offering only a partial IVF cycle rather than a full cycle as defined by NICE.

A full IVF cycle generally includes ovarian stimulation, egg collection and the transfer of all suitable fresh and frozen embryos created during treatment.

Crossbench peer Professor Baroness Clare Gerada, a former president of the Royal College of General Practitioners, said: “The proportion of NHS-funded IVF cycles has fallen to just under 30 per cent, the lowest level since 2008.”

She added that, in relation to IVF, “the NHS system has collapsed”.

Liberal Democrat peer Lord Monroe Palmer said it was “very ironic that it is difficult for many patients to access publicly funded fertility treatment in the very country where IVF was originally pioneered”.

Conservative peer Edward Howard, Earl of Effingham, also raised concerns about the NICE fertility guideline.

He said: “Access remains highly variable across England, because ICBs are not required to implement that guidance.”

He described the situation as “a clear gap between guidance and enforceable entitlement”.

Baroness Deech called for “automatic record sharing between clinics and the NHS central records system”.

Baroness Nargund supported this and linked the ambition to the Single Patient Record in the government’s Ten-Year Health Plan for England and the Health Bill currently before Parliament.

Baroness Pidgeon said such ambitions were at odds with the exceptional degree of medical secrecy that currently applies to IVF.

She also pointed to “a clear desire for the HFEA to be able to permit patients to give generic consent for the use of their embryos in research”.

Patients cannot currently give broad consent for unspecified future research involving their embryos.

Responding for the government, Labour peer Baroness Judith Blake said “immediate legislative reform” was not possible because “the legislative programme for this Parliamentary session is very full”.

Baroness Deech replied: “It might well take some years, but the Government really needs to set up that Select Committee and do the legislative scrutiny right now.”

A second debate on related issues followed immediately afterwards.

Baroness Nargund asked the government “what assessment they have made of the UK’s declining birthrates in an ageing population”.

She also said: “We still have a postcode lottery for IVF provision, with nearly 70 per cent of ICBs funding only one cycle of treatment.”

Responding for the government, Labour peer Lord Philip Wilson said: “The Government are committed to improving fair and equitable access to fertility services, recognising the significant emotional and health impacts of infertility.”