Hope Medicine Reports Positive Phase 2 Results for Non-Hormonal Endometriosis Treatment HMI-115
核心洞察
Hope Medicine (搜索) completed a Phase 2 trial of HMI-115, a monoclonal antibody targeting the prolactin receptor (搜索), showing statistically significant pain reduction in 108 women with endometriosis (搜索).
The 240 mg dose group experienced a 42% reduction in dysmenorrhea (搜索) pain scores and 52% reduction in non-menstrual pelvic pain (搜索) compared to baseline without causing typical perimenopausal symptoms.
The treatment maintained normal menstrual patterns and sex hormone levels while showing no treatment-related serious adverse events over the 12-week study period.
Hope Medicine (搜索) has announced positive results from a Phase 2 clinical trial of HMI-115, a first-in-class monoclonal antibody targeting the prolactin receptor (搜索) for endometriosis (搜索) treatment. The Beijing-based biopharmaceutical company reported the findings on October 7, 2025, marking a potential breakthrough in non-hormonal therapy for a condition affecting approximately 190 million women worldwide.
Trial Design and Patient Population
The randomized, double-blind, placebo-controlled study enrolled 108 women with surgically diagnosed endometriosis (搜索) across multiple countries including the United States, Poland, and China. The 12-week treatment period evaluated the safety and efficacy of HMI-115 in addressing endometriosis-associated pain, a primary symptom affecting approximately 10% of women of childbearing age.
Significant Pain Reduction Without Hormonal Side Effects
Patients receiving the 240 mg dose administered every two weeks demonstrated statistically significant improvements in pain management. The least-square-mean dysmenorrhea (搜索) pain score was reduced by 42% compared to baseline, while non-menstrual pelvic pain (搜索) scores showed a 52% reduction. These results represent meaningful clinical improvements for patients suffering from chronic pelvic pain, dysmenorrhea, and painful intercourse associated with endometriosis (搜索).
Notably, HMI-115 did not produce typical perimenopausal symptoms commonly associated with current hormonal treatments. The study showed no significant changes in menstrual patterns, bone mineral density, or sex hormone levels including estradiol, LH, FSH, and progesterone. Most patients maintained normal menstrual periods throughout the treatment period.
Safety Profile and Clinical Significance
The treatment demonstrated a favorable safety profile with no treatment-related serious adverse events reported during the study period. This safety data is particularly significant given the chronic nature of endometriosis (搜索) and the need for long-term treatment options.
Dr. Lan Zhu, director of gynecology at Peking Union Medical College Hospital and leading investigator of the study, emphasized the clinical implications: "HMI-115 relieved endometriosis (搜索) pain in women without disturbing their sex hormones. It can potentially shift the treatment paradigm. We will be able to treat women without menopausal side effects or even infertility."
Market Opportunity and Regulatory Path Forward
Endometriosis (搜索) represents a substantial unmet medical need with an estimated market value of approximately $180 billion. The condition causes significant symptoms including pelvic pain (搜索), dysmenorrhea (搜索), painful intercourse, and infertility, often requiring surgical intervention for definitive diagnosis.
Nathan Chen, CEO of Hope Medicine (搜索), confirmed that the company is actively communicating with key regulatory agencies, including the FDA and China's National Medical Products Administration (NMPA), to finalize Phase 3 protocols. The company plans to initiate global Phase 3 studies following regulatory guidance.
Company Background and Development Pipeline
Hope Medicine (搜索) is a clinical-stage biopharmaceutical company with operations in Beijing, Shanghai, and Nanjing, China. The company was founded based on research from Professor Rui-Ping Xiao's laboratory at the Institute of Molecular Medicine of Peking University (搜索), focusing on innovative therapeutic approaches for women's health conditions.
The successful Phase 2 results position HMI-115 as a potential first-in-class treatment that could address the significant limitations of current hormonal therapies, offering hope for millions of women seeking effective endometriosis (搜索) treatment without compromising fertility or causing menopausal side effects.