Hope Medicine, a Shanghai-based clinical-stage biopharmaceutical company, has dosed the first patient in its Phase III clinical trial of HMI-115 – a first-in-class monoclonal antibody targeting the prolactin receptor for the treatment of moderate-to-severe endometriosis pain.
That distinction matters. Current endometriosis treatments are almost entirely hormonal – GnRH agonists, progestins, aromatase inhibitors – and come with significant trade-offs including bone density loss, menopausal symptoms, and the inability to conceive while on treatment. A non-hormonal approach that effectively treats endo pain without those side effects would represent a fundamental shift in the treatment paradigm.
The Phase II data, published in The Lancet Obstetrics, Gynaecology, & Women’s Health, showed that HMI-115 achieved statistically significant improvement in moderate-to-severe endometriosis pain with no significant impact on key female hormones and no menopausal side effects. Those results earned the drug FDA Fast Track Designation in the U.S. and Breakthrough Therapy Designation from China’s NMPA – dual regulatory recognition that underscores the clinical promise.
HMI-115 was originally licensed from Bayer AG in 2019 under a worldwide exclusive agreement targeting the prolactin receptor, giving the science established pharmaceutical pedigree. Hope Medicine holds global rights.
The Phase III trial is a multicenter, randomized, double-blind, placebo-controlled study with a 24-week treatment period, launched at Peking Union Medical College Hospital as the leading site. It is designed to confirm the safety and efficacy findings from Phase II and support marketing authorization.
“The launch of the Phase III trial signifies that the global development of HMI-115 for endometriosis has entered its final stage,” said CEO Chen Xi. “Women’s health is a key focus area for Hope Medicine, and we will drive this trial with the best speed and quality to bring this innovative treatment to patients as soon as possible.”
