Clinical-stage biopharmaceutical company Hope Medicine Inc announced on Tuesday that the first patient has been dosed in the Phase III clinical trial of HMI-115, its first-in-class monoclonal antibody with global rights, for the treatment of endometriosis.
The dosing took place at the leading study site in China, Peking Union Medical College Hospital.
The multicentre, randomised, double-blind, placebo-controlled study is designed to confirm the safety and efficacy of HMI-115 in treating moderate-to-severe pain associated with endometriosis, with a treatment period of 24 weeks. HMI-115 is currently the first and only non-hormonal therapy globally to have entered Phase III clinical development.
HMI-115 was previously granted Fast Track Designation by the US Food and Drug Administration (FDA) for the treatment of moderate-to-severe pain associated with endometriosis. Additionally, it was granted Breakthrough Therapy Designation (BTD) by the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA).
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