Hope Medicine Reports Positive Global Phase 2 Results for Endometriosis Treatment and Earns Breakthrough Therapy Status

SHANGHAI, Oct. 23, 2024 – Hope Medicine Inc. (HopeMed), a clinical-stage innovative biopharmaceutical company, has reported promising results from an interim analysis of its global Phase 2 study. The study, titled "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," evaluates the effectiveness of HMI-115, a monoclonal antibody that blocks the prolactin receptor, in treating endometriosis. This first-in-class treatment for endometriosis has also received Breakthrough Therapy Designation from China’s National Medical Products Administration (NMPA).

The Phase 2 study included 142 female patients from the United States, Poland, and China, all diagnosed with endometriosis. Interim analysis of this study revealed that HMI-115 significantly alleviates endometriosis-associated pain and is well-tolerated without any serious adverse events related to the treatment. Among the first 102 patients analyzed, there was a notable reduction in pain scores. Specifically, the mean dysmenorrhea pain score dropped by 42% in the 240 mg q2w group, and the mean non-menstrual pelvic pain score was reduced by 50%. These findings were statistically significant when compared to the placebo group. Additionally, the majority of patients reported normal menstrual periods without experiencing typical peri-menopausal symptoms. There were no significant changes in bone mineral density or in key sex hormone levels, including estradiol, LH, FSH, and progesterone.

Dr. Hugh Taylor, a prominent professor at Yale School of Medicine, emphasized the impact of endometriosis as a common and debilitating disease among women. He highlighted that for decades, patients and healthcare providers have been seeking treatments that relieve pain without altering sex-steroid hormones. HMI-115 appears to meet this unmet medical need, offering potential relief for many women.

Dr. Jeffrey Jensen from Oregon Health & Science University expressed excitement over the study’s findings. He noted that unlike existing treatments such as GnRH blockers, HMI-115 does not disrupt the menstrual cycle and maintains normal physiological levels of sex hormones, thereby preventing menopausal symptoms and bone loss. This unique approach, which is not contraceptive, could be particularly beneficial to women with endometriosis who wish to conceive. Dr. Jensen was impressed by the significant impact seen in both menstrual and non-menstrual pain.

Professor Rui-Ping Xiao, the founder of Hope Medicine, remarked on the significance of this study. It is the first to demonstrate that blocking the prolactin receptor can effectively treat endometriosis pain. Professor Xiao stated that for the past four decades, there has been a call for new targets that provide pain relief while avoiding sex hormone disruption, and HMI-115 answers this call.

Nathan Chen, CEO of Hope Medicine, expressed optimism about the trial’s success. In the forthcoming months, Hope Medicine plans to hold meetings with the FDA, NMPA, and other key regulatory authorities to determine the next steps for HMI-115’s development. The company aims to commence global Phase 3 trials promptly to make HMI-115 available to patients as soon as possible, reaffirming their commitment to improving women's health worldwide.

Endometriosis affects approximately 190 million women globally, representing a market size of around $200 billion. This condition impacts about 10% of women of childbearing age and is characterized by the implantation of endometrial cells outside the endometrium, leading to chronic inflammation. Common symptoms include lower abdominal and pelvic pain, dysmenorrhea, painful intercourse, and infertility. Endometriosis significantly impacts patients' quality of life, affecting their sexual, psychological, and social well-being.

Hope Medicine Inc. is a clinical-stage biopharmaceutical company with a focus on developing innovative medicines for significant unmet medical needs. With research laboratories and offices in Beijing, Shanghai, and Nanjing, China, the company is built on the expertise of Professor Rui-Ping Xiao from Peking University’s Institute of Molecular Medicine. HopeMed’s mission is to improve the quality of life through scientific research and the development of first-in-class treatments for major diseases.