For millions of women living with endometriosis, persistent pain can disrupt daily life, affect fertility and limit treatment choices. Existing hormonal therapies may provide relief but can cause significant side effects, highlighting the need for alternatives. Gesynta Pharma is developing vipoglanstat, a non-hormonal treatment designed to target inflammation and pain. Following early completion of enrolment in its Phase 2 NOVA trial, Biopharma Boardroom speaks with Patric Stenberg, CEO of Gesynta Pharma, about the unmet needs of patients, the drug's clinical potential and plans for Phase 3 development, with topline results expected in Q2 2027.

Q. Gesynta Pharma has completed enrollment in the Phase 2 NOVA trial more than three months ahead of schedule, exceeding its original recruitment target. What do you believe drove this strong patient interest, and what does this milestone mean for the development of vipoglanstat? 

We believe the strong recruitment rate reflects the significant interest in new approaches to treating endometriosis – particularly effective, non-hormonal options. Completing enrollment more than three months ahead of schedule and exceeding our original recruitment target highlights the enthusiasm patients and investigators share for advancing new therapies in this underserved area. For vipoglanstat, this is an important development milestone that allows the NOVA trial to progress as planned toward Phase 2 data.

Q. Endometriosis remains a challenging condition to manage, with many women experiencing persistent pain despite available treatments. What are the biggest gaps in current treatment options, and how could vipoglanstat help address these unmet needs? 

Despite affecting more than one in ten women of reproductive age globally, endometriosis remains a significantly underserved area of women's health. Current second-line hormonal treatment options have important limitations, as they can cause menopause-like side effects, compromise fertility, and are unsuitable for long-term use. Importantly, these treatments broadly suppress hormonal activity rather than directly targeting the inflammatory processes driving pain and lesion growth. In contrast, vipoglanstat is being developed as a non-hormonal option directly targeting these processes and has the potential to provide a much-needed alternative for women who do not respond adequately to, cannot tolerate, or do not wish to use hormonal treatments, addressing the urgent need for safe and effective long-term disease management.

Q. Vipoglanstat takes a non-hormonal, non-opioid approach by targeting the mPGES-1 enzyme. How does this mechanism differ from existing endometriosis therapies, and what potential advantages could it offer in terms of long-term treatment, side effects and fertility?

Vipoglanstat takes a fundamentally different approach to existing endometriosis therapies by selectively inhibiting mPGES-1, a key enzyme responsible for producing prostaglandin E2 (PGE₂), a major driver of inflammation, pain, and lesion growth in endometriosis. Rather than suppressing hormonal activity, as existing hormonal therapies do, vipoglanstat is designed to act on an inflammatory pathway involved in the disease. By selectively targeting mPGES-1, vipoglanstat has the potential to overcome the key limitations of current options and provide a novel, targeted treatment option for patients.

Q. Preclinical studies have shown reductions in both pain-related behaviors and endometriotic lesions. How important is the possibility of addressing both symptoms and the underlying disease, and what evidence would be needed to demonstrate this benefit in patients? 

In NOVA, our primary focus is demonstrating a meaningful reduction in moderate-to-severe endometriosis pain. We are also assessing outcomes such as use of opioid rescue medication, and quality of life measures, while exploratory MRI imaging will evaluate changes in lesion burden. Together, these data will help us understand the broader clinical potential of vipoglanstat and inform its future development.

Q. The NOVA trial is evaluating two dose levels of vipoglanstat in 213 women. What are the most important clinical outcomes you will be looking for, and how will the results help determine the optimal dose and design of a future Phase 3 program?

NOVA is both a proof-of-concept and dose-finding study, so we will be looking at the efficacy and safety profiles across both dose levels. Clinically, we want to see a meaningful reduction in moderate-to-severe endometriosis pain, alongside a tangible impact on patients’ daily lives. The trial includes a broad range of pain-related endpoints designed to capture the potential impact of vipoglanstat on aspects of pain important to patients, as well as assessments of the use of opioid rescue medication and quality-of-life outcomes. It also features an exploratory MRI endpoint evaluating changes in lesion burden. Together, these findings will provide important information on the relative profiles of the two doses and help guide dose selection and the overall design of a subsequent Phase 3 programme.

Q. With topline Phase 2 results expected in the second quarter of 2027, what are Gesynta Pharma's key priorities over the coming months, and how are you preparing for the next stage of clinical development and potential commercialization?

Our immediate priority is the successful completion of NOVA and delivery of topline results in Q2 2027. At the same time, we are advancing Phase 3 preparations to ensure a seamless transition into the next stage of development. Beyond the Phase 2 readout, our priority is to capture value from this critical milestone by securing the optimal partnering or financing transaction to drive vipoglanstat through Phase 3 and toward commercialization.