Hope Medicine Inc. announces positive results from a global Phase 2 study of a first-in-class endometriosis treatment and breakthrough therapy designation

SHANGHAI, Oct. 24, 2024 /PRNewswire/ -- Hope Medicine Inc. ('HopeMed'), a clinical-stage innovative biopharmaceutical company, announced positive results from an interim analysis of a global Phase 2 study, " A Randomized, Multicenter, Double-Blind, Placebo -Controlled Phase 2 Study to Evaluate the Safety and Efficacy of HMI-115 in Women with Moderate to Severe Endometriosis Associated Pain Over a 12-Week Treatment Period". HMI-115 is a monoclonal antibody that blocks the prolactin receptor. It is a first-in-class treatment for endometriosis. Notably, HMI-115 has been granted Breakthrough Therapy Designation by the National Medical Products Administration ("NMPA") in China.

This Phase 2 study included 142 female patients with endometriosis in US, Poland and China. HMI-115 has demonstrated statistically significant improvement in endometriosis associated pain. HMI-115 was well-tolerated with no treatment-related serious adverse events. Specifically, in the first 102 patients included in the interim analysis, at the end of the study treatment, the mean dysmenorrhea pain score was reduced by 42% in the 240 mg q2w group, compared to the baseline. The mean non-menstrual pelvic pain score was reduced by 50%. These reductions were statistically significant compared to placebo. Most of the patients reported normal menstrual periods. No typical peri-menopausal symptoms were reported. There were no significant changes in bone mineral density and sex hormone levels including estradiol, LH, FSH and progesterone.

"Endometriosis is a common and debilitating disease among women," said Dr. Hugh Taylor, Anita O'Keeffe Young Professor of Obstetrics, Gynecology, and Reproductive Sciences and Professor of Molecular, Cellular, and Developmental Biology, at Yale School of Medicine, "for decades, patients and physicians have been seeking an endometriosis treatment that provides pain relief and does not alter sex-steroid hormones. HMI-115 has the potential to fulfill this unmet medical need."

"The findings from this proof-of-concept study are exciting," said Dr. Jeffrey Jensen, Leon Speroff Professor of Obstetrics and Gynecology, at the School of Medicine, Oregon Health & Science University, "in contrast to existing treatments like GnRH blockers, HMI-115 does not disrupt the normal menstrual cycle and maintains physiologic levels of sex hormones to prevent menopausal symptoms and bone loss. Unlike hormonal therapies, the approach is not contraceptive and could offer particular benefit to women with endometriosis seeking pregnancy. I was very impressed to see a significant impact on both menstrual and non-menstrual pain."

"HMI-115 is first-in-class," said Professor Rui-Ping Xiao, founder of Hope Medicine, "this study is the first ever to show that prolactin receptor blockade can treat patients suffering from endometriosis. For the last 40 years people have been calling for a new target that provides pain relief while bypassing sex hormones, we are answering that call."

"We are very encouraged by the success of this proof-of-concept trial," said Nathan Chen, CEO of Hope Medicine," in the coming months, we plan to hold End-of-Phase 2 meetings with FDA, NMPA, and other key regulatory authorities to determine next steps for the development of HMI-115. We plan to move quickly towards global Phase 3 trials, so that patients can begin to benefit from HMI-115 as soon as possible. We are dedicated to improving women's health worldwide."