Clinical-stage biopharmaceutical company Hope Medicine Inc. (HopeMed) announced on Wednesday positive results from an interim evaluation of a global Phase two study, 'A Randomised, Multicentre, Double-Blind, Placebo -Controlled Phase two 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, a monoclonal antibody, blocks the prolactin receptor and is a first-in-class treatment for endometriosis and received Breakthrough Therapy Designation from 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. The company says that 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 percent in the 240 mg q2w group, compared to the baseline. The mean non-menstrual pelvic pain score decreased by 50 percent.
Dr Jeffrey Jensen, Leon Speroff professor of Obstetrics and Gynecology, at the School of Medicine, Oregon Health & Science University, said, 'The findings from this proof-of-concept study are exciting 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.'
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