Gesynta Pharma Reaches 50% Randomization Milestone in Phase 2 NOVA Trial of Non-Hormonal Endometriosis Drug Vipoglanstat
核心洞察
Gesynta Pharma (搜索) has randomized 50% of the target 190 patients in its Phase 2 NOVA trial evaluating vipoglanstat for endometriosis (搜索), with enrollment progressing ahead of schedule.
Vipoglanstat is a novel, oral, non-hormonal, non-opioid drug candidate targeting mPGES-1 to reduce pain and inflammation in endometriotic lesions.
The randomized, double-blind, placebo-controlled trial assesses two dose levels over four menstrual cycles, with top-line results expected in 2027.
Gesynta Pharma (搜索) AB, a Swedish clinical-stage pharmaceutical company, announced today that 50% of the target 190 patients have been randomized in its Phase 2 clinical proof-of-concept NOVA trial evaluating vipoglanstat, a novel non-hormonal, non-opioid drug candidate for the treatment of endometriosis (搜索). The milestone was reached well ahead of schedule, reflecting what the company describes as strong participation from clinical sites and significant interest among eligible participants.
"Reaching the halfway point in patient recruitment marks a major milestone for our Phase 2 clinical trial in endometriosis (搜索). 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," said Eva Johnsson, Chief Medical Officer and VP Clinical Development at Gesynta Pharma (搜索). "We are now eager to complete enrollment and proceed to the next phase of evaluation."
Mechanism of Action and Preclinical Rationale
Vipoglanstat is an orally active drug candidate designed to reduce pain and inflammation by targeting mPGES-1, a key enzyme responsible for producing the proinflammatory mediator prostaglandin E2 (PGE2) in endometriotic lesions. A preclinical proof-of-concept study in an advanced endometriosis (搜索) model demonstrated that vipoglanstat significantly reduced pain-related behaviors and endometriotic lesion burden. Previous clinical studies have confirmed the drug candidate's safety, tolerability, and favorable pharmacodynamic effects in humans, supporting further development as a non-hormonal, non-opioid treatment approach.
NOVA Trial Design
The NOVA trial (Non-hormonal Option – a Vipoglanstat Assessment) is a randomized, double-blind, placebo-controlled Phase 2 proof-of-concept study evaluating vipoglanstat in women with endometriosis (搜索) across Europe. Approximately 190 patients aged 18 to 45 will receive vipoglanstat or placebo over a period of four menstrual cycles. The trial assesses the efficacy and safety of two dose levels of vipoglanstat and is designed to provide important information for the design of a subsequent Phase 3 program.
The primary objective is to evaluate the efficacy of vipoglanstat on endometriosis (搜索)-related pain during non-menstrual days. Secondary objectives include assessing the effect on menstrual pain (dysmenorrhea), pain during sexual intercourse (dyspareunia), use of opioid rescue medication, and quality-of-life measures. Changes in endometriotic lesions assessed by MRI will also be explored.
Unmet Need in Endometriosis (搜索)
Endometriosis (搜索) is a painful chronic inflammatory disorder in which tissue similar to the uterus lining grows outside the uterus, mainly in the pelvic cavity, causing inflammation, fibrosis, and the formation of endometriotic lesions and adhesions. The condition commonly presents with severe period pain, pain between periods (non-menstrual pelvic pain), pain during sexual intercourse, gastrointestinal symptoms, and infertility. Despite affecting more than 10% of women of reproductive age, endometriosis remains a critically underserved area of women's health, significantly underdiagnosed and undertreated, with few new treatment options available. Current management is typically limited to analgesics, hormonal therapies, and surgery.
Strategic Significance
"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 program for vipoglanstat," said Patric Stenberg, CEO of Gesynta Pharma (搜索). "Given the immense medical need, our focus remains on delivering a treatment that is highly effective, safe, and well-tolerated."
Gesynta Pharma (搜索)'s research on targeting mPGES-1 originated at Karolinska Institutet in Sweden. Beyond vipoglanstat, the company's pipeline includes a second drug candidate, GS-073, which 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 internationally renowned specialist investors. Top-line results from the NOVA trial are anticipated in 2027.