Maipl Therapeutics, Inc. and Endosure, Inc. announced a strategic alliance today aimed at accelerating the development of a novel non-hormonal therapy for endometriosis. The collaboration will leverage Endosure's innovative diagnostic technology to expedite clinical studies of Maipl's lead candidate MA-4604, a first-in-class antagonist of the Prostaglandin-F2α receptor (FP).
The partnership addresses two critical challenges in endometriosis drug development: timely diagnosis and objective measurement of treatment efficacy. By incorporating the ENDOSURE TEST into MA-4604's clinical development program, Maipl aims to streamline patient identification, enrollment, and pharmacodynamic assessment.
"Our alliance with Endosure allows us to leap-frog two of the greatest hurdles in endometriosis drug development—timely and accurate diagnosis and objective measurement of treatment effect," said Dr. Yong Yue, Chief Executive Officer of Maipl Therapeutics. "By incorporating the ENDOSURE TEST into the MA-4604 development program, we have the potential to recruit the right patients faster, monitor response in near-real time, and ultimately bring a much-needed, non-hormonal option to millions of women suffering from this debilitating disease."
The Endometriosis Challenge
Endometriosis affects approximately one in ten women of reproductive age—nearly 200 million worldwide—and imposes an annual economic burden of US $69.8 billion in the United States alone. This systemic, chronic disorder is characterized by ectopic endometrial tissue and severe pain.
A particularly troubling aspect of endometriosis management is the significant diagnostic delay, which averages eight to ten years. This prolonged period without proper diagnosis allows the disease to progress, often leading to infertility, organ damage, and diminished quality of life.
MA-4604: A Novel Approach to Endometriosis Treatment
MA-4604 represents a departure from traditional hormonal therapies for endometriosis. As a highly potent and selective antagonist of the Prostaglandin-F2α receptor, it targets a key driver of endometriosis-associated menstrual pain resulting from dysregulated smooth muscle contractions and inflammation.
Preclinical studies have yielded promising results, demonstrating robust reduction of uterine contractions, lesion burden, and pain response in validated animal models. Maipl expects to initiate Phase 1 clinical trials in the second quarter of 2026.
The ENDOSURE TEST: Transforming Diagnosis
The ENDOSURE TEST is positioned as a game-changer in endometriosis diagnosis. This non-invasive, EKG-like myoelectrical assay can be completed in approximately 30 minutes and offers impressive accuracy with >99% sensitivity and >95% specificity, regardless of the anatomical location of endometriotic lesions.
In clinical trials, the test has dual utility: it enables non-invasive patient identification and serves as a quantitative pharmacodynamic biomarker of post-treatment disease activity. This represents a significant advancement over the current gold standard of laparoscopic surgery for definitive diagnosis.
"The combination of a Tier-1 diagnostic with a truly innovative, non-hormonal therapeutic candidate could redefine the standard of care in endometriosis," said Carlos Babini, Chief Executive Officer of Endosure. "We are thrilled that our technology will help Maipl expedite patient recruitment as well as objectively measure the impact of MA-4604."
Strategic Implementation
The alliance will initially focus on incorporating the ENDOSURE TEST into MA-4604's clinical development program. This includes its use in the upcoming Phase 1b study in patients with endometriosis to demonstrate target engagement and assist in dose selection for Phase 2.
Compared to previous trials that required definitive diagnosis by laparoscopic surgery—a factor that significantly prolonged recruitment—the ENDOSURE TEST has the potential to substantially expedite enrollment in future clinical trials.
Market Implications
The ENDOSURE TEST is already commercially available in select markets, with plans for 510K approval submission in the United States in the near future. Meanwhile, MA-4604 is positioned to be the first FP receptor antagonist to enter human trials.
If successful, this collaboration could significantly impact the endometriosis treatment landscape, offering a non-hormonal alternative to the millions of women affected by this condition. The current standard of care primarily consists of hormonal therapies, which often come with significant side effects and limitations.
Maipl Therapeutics is a privately held biopharmaceutical company headquartered in Scarsdale, New York, focused on pioneering non-hormonal treatments for women's health disorders. Endosure, Inc. is dedicated to transforming the detection and management of endometriosis through innovative diagnostic solutions.
