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Subcutaneous injection of HMI-115 delivers statistically significant pain relief in premenopausal women with endometriosis, marking a potential breakthrough in non-hormonal therapy.
Endometriosis remains a chronic, painful condition that disrupts reproductive-age women’s quality of life, with limited effective non-hormonal treatments. Dysregulated prolactin signaling is increasingly implicated in disease pathology, suggesting new therapeutic avenues. The trial led by Lan Zhu et al. aimed to assess whether HMI-115, a prolactin receptor-blocking monoclonal antibody, could safely and effectively tackle moderate-to-severe endometriosis-associated pain.
The multicenter, double-blind, randomized phase 2 study enrolled premenopausal women aged 18–49 with surgically confirmed endometriosis. Volunteers were randomly assigned to receive HMI-115 at doses of 60 mg, 120 mg, or 240 mg, or placebo, administered subcutaneously every two weeks for 12 weeks. Pain outcomes were measured using numerical rating scales (NRS) for dysmenorrhea and non-menstrual pelvic pain, while safety evaluations included adverse events, clinical labs, electrocardiograms, vital signs, and bone density.
Blinding was maintained across participants, investigators, and site staff. The results showed that dysmenorrhea NRS scores declined in a dose-dependent manner at week 12 , with only the 240 mg dose reaching statistical significance versus placebo (Table 1).
Treatment-emergent adverse events increased with dose and were primarily mild to moderate, including injection-site reactions, dizziness, nausea, nasopharyngitis, and headaches.
One serious adverse event occurred in the 240 mg group but was unrelated to treatment; no fatalities were reported. No deaths were reported. HMI-115 demonstrated a dose-dependent, statistically significant reduction in endometriosis-associated dysmenorrhea at the highest dose while maintaining an acceptable safety profile, supporting progression to larger-scale, longer-term phase 3 trials.
The Lancet Obstetrics, Gynaecology, & Women’s Health Home
Safety and efficacy of subcutaneous injection with HMI-115 versus placebo in endometriosis-associated pain in premenopausal women: a multicentre, double-blind, randomised, proof-of-concept phase 2 trial
Lan Zhu et al.
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