Hope Medicine Announces US FDA Clearance for Phase II Clinical Trial of A First-in-class Monoclonal Antibody, HMI-115, in Androgen Alopecia

SHANGHAI, Jan. 25, 2022 /PRNewswire/ -- Hope Medicine Inc. ('HopeMed'), a clinical stage innovative biopharmaceutical company, has recently announced that U.S. Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application for phase II study to evaluate HMI-115, a first-in-class monoclonal antibody drug in treating androgen alopecia. In 2021, HMI-115 already received the US FDA Clearance of IND Application for Phase II clinical trial for the treatment of endometriosis.

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 company. 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."

About Hope Medicine

Hope Medicine Inc. is a science-driven clinical-stage biopharmaceutical company with research bases and offices in Beijing, Shanghai and Nanjing, China. The establishment of the company is based on the in-depth understanding of the research field of translational medicine and decades of research results of Professor Rui-Ping Xiao's laboratory at the College of Future Technology of Peking University. Based on excellent scientific research and with the goal of improving the quality of life, HopeMed is committed to the research, development, and commercialization of first-in-class medicines for common and major diseases that threaten human health. The company finalized round B financing in May 2021 following a world-wide exclusive license agreement with Bayer AG on the development and commercialization of HMI-115.  HopeMed also established a diversified research portfolio based on the Professor Xiao's breakthrough research at the Institute of Molecular Medicine (IMM) at Peking University via a joint research lab, with a strong translational focus, for a continuous innovative early discovery pipeline.

About Androgenic Alopecia

Androgenetic Alopecia is the most common type of hair loss and affects up to 70% of men and 40% of women. While male and female pattern hair loss is commonly believed to be due to a combination of genetics and the male hormone dihydrotestosterone, the detailed mechanism remains unclear. Data published by a Bayer team as well as data generated jointly point to a yet hardly recognized role of prolactin/prolactin-receptors signaling in the disorder.

About Endometriosis

Endometriosis is a chronic estrogen-dependent gynecological disease defined by the presence of endometrium-like tissue outside the uterus, which induces a chronic inflammatory reaction. The endometrium is a layer of mucous tissue, which lines the uterus cavity and undergoes hormone-dependent changes during the menstrual cycle. Endometriosis is a common disease among women of reproductive age. The prevalence is estimated to be up to 10% in women of childbearing age worldwide. Lower abdominal and pelvic pain, cramping menstrual pains (dysmenorrhea), painful sexual intercourse (dyspareunia) and infertility are well recognized symptoms of endometriosis. It has been reported that Asian women have a higher endometriosis prevalence in comparison to Caucasians and African Americans. A recent study found the prevalence to be higher among Filipino, Indian, Japanese and Korean women (15.7%) when comparing to Caucasian women (5.8%).  Endometriosis is typically associated with a lower quality of life and significant physical, sexual, psychological and social impact. The cause of endometriosis is not entirely clear, and there is no cure for endometriosis. Typically, there are two types of interventions: treatment of pain and treatment of endometriosis-associated infertility.

Forward-Looking Statements

This press release contains forward-looking statements that are primarily based on the current outlook, expectations, estimates and projections of the company's management team. In the use of "anticipate," "believe," "may," "design," "effect," "assess," "expect," "predict," "target," "purpose" and any other similar words and expressions, where all references to the company, are intended to identify as forward-looking statements. Forward-looking statements are subject to risks and uncertainties, many of which are difficult to predict and often beyond the company's control, which could cause actual results to differ from the forward-looking statements. The company undertakes no public announcement obligation to update or revise any forward-looking statement.

SOURCE Hope Medicine Inc.