Hope Medicine Inc. has announced positive results from an interim analysis of its global Phase 2 study evaluating HMI-115, a novel monoclonal antibody, in women with moderate to severe endometriosis-associated pain. The study, a randomized, multicenter, double-blind, placebo-controlled trial, demonstrated statistically significant improvements in endometriosis pain with HMI-115, marking a potential breakthrough in the treatment of this debilitating condition.
The Phase 2 study included 142 female patients across the US, Poland, and China. Interim analysis of the first 102 patients showed that HMI-115 significantly reduced both dysmenorrhea and non-menstrual pelvic pain. Specifically, the mean dysmenorrhea pain score decreased by 42% in the 240 mg q2w group compared to baseline, while the mean non-menstrual pelvic pain score was reduced by 50%. These reductions were statistically significant versus placebo.
HMI-115: A Novel Approach to Endometriosis Treatment
HMI-115 is a first-in-class treatment that blocks the prolactin receptor. This mechanism of action differs from existing treatments like GnRH blockers, which disrupt the normal menstrual cycle and can cause menopausal symptoms and bone loss. Notably, HMI-115 has received Breakthrough Therapy Designation from China's National Medical Products Administration (NMPA).
Preserving Hormonal Balance
A key advantage of HMI-115 is its ability to provide pain relief without altering sex-steroid hormones. The study reported that most patients on HMI-115 experienced normal menstrual periods, with no typical peri-menopausal symptoms. Furthermore, there were no significant changes in bone mineral density or key sex hormone levels, including estradiol, LH, FSH, and progesterone.
Expert Commentary
"Endometriosis is a common and debilitating disease among women," said Dr. Hugh Taylor, Anita O'Keeffe Young Professor of Obstetrics, Gynecology, and Reproductive Sciences 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."
Dr. Jeffrey Jensen, Leon Speroff Professor of Obstetrics and Gynecology at Oregon Health & Science University, added, "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."
Next Steps
Hope Medicine plans to hold End-of-Phase 2 meetings with the FDA, NMPA, and other regulatory authorities to discuss the path forward for HMI-115. The company aims to initiate global Phase 3 trials to expedite the availability of this potential new treatment for women with endometriosis.
Endometriosis: A Widespread Condition
Endometriosis affects approximately 190 million women worldwide, representing a substantial global market estimated at $200 billion. The condition, characterized by the presence of endometrial cells outside the uterus, leads to chronic inflammation and symptoms such as pelvic pain, dysmenorrhea, and infertility. Current treatments often have significant side effects, highlighting the need for novel therapies like HMI-115.
