New Clinical Trial of Investigational New Drug for Treatment of Alopecia

In April 2019, HopeMed entered a world-wide exclusive license agreement with Bayer AG on the development and commercialization of a human monoclonal antibody targeting the PRL receptor for the treatment of male and female pattern hair loss, endometriosis, and other chronic diseases with dysregulated prolactin (PRL) signaling. This antibody has shown excellent characteristics in animal models including NHP models and human safety study. Its treatments for two main indications, endometriosis and androgenetic alopecia, both have been approved by the US FDA for Phase II clinical trials. The phase II clinical trial of HMI-115 in endometriosis already initiated patient enrollment in the U.S. by the end of 2021. Its Phase II clinical trial for the treatment of androgenetic alopecia is an international multi-center, randomized, double-blind, placebo-controlled study, which is planned to be carried out in the United States, Australia and other countries.

Dr. Henri Doods, the CEO of HopeMed, said “I am very proud that the FDA also approved our second IND which is an important milestone for our young . It is an important step towards our mission to bring First-in-Class and highly differentiated products to patients. Both endometriosis and alopecia are indications where patients are eagerly waiting for new treatment options with improved efficacy and safety. The success of having two IND approvals in such a short period of time is an encouragement for the whole team. We are highly committed to further strengthen and expand our R&D activities to bring novel innovative therapeutic options to patients globally.”

 

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