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

SHANGHAI, January 25, 2022 /PRNewswire/ — Hope Medicine Inc. (“HopeMed”), an innovative clinical-stage biopharmaceutical company, recently announced that the U.S. Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application. for a phase II study to evaluate HMI-115, a first-in-class monoclonal antibody in the treatment of androgenic alopecia. In 2021, HMI-115 has already received clearance from the US FDA for the IND application for a phase II clinical trial for the treatment of endometriosis.

In April 2019, HopeMed has entered into a worldwide exclusive licensing agreement with Bayer AG to develop and commercialize a human monoclonal antibody targeting the PRL receptor for the treatment of male and female pattern baldness, endometriosis and other chronic diseases with Dysregulated prolactin (PRL) signaling. This antibody has shown excellent characteristics in animal models, including NHP models and a human safety study. Its treatments for two main indications, endometriosis and androgenetic alopecia, have both been approved by the US FDA for phase II clinical trials. The phase II clinical trial of HMI-115 in endometriosis has already started enrolling patients in the United States by the end of 2021. Its phase II clinical trial for the treatment of androgenetic alopecia is a international multicenter, randomized, double-blind, placebo-controlled study, the realization of which is planned in United States, Australia and other countries.

dr. Henry DoodsCEO of HopeMed, said “I am very proud that the FDA has also cleared our second IND, which is an important milestone for our young company. This is an important step towards our mission to bring world-class products. class and highly differentiated endometriosis and alopecia are indications for which patients are eagerly awaiting new treatment options with improved efficacy and safety The success of having two IND approvals in such a short time is a encouragement for the whole team. We are very committed to strengthening and expanding our R&D activities to bring new innovative therapeutic options to patients around the world.”

On Hope Medicine

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

About Androgenic Alopecia

Androgenetic alopecia is the most common type of hair loss and affects up to 70% of men and 40% of women. Although hair loss in both men and women is generally thought 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 jointly generated data point to a still little recognized role of prolactin/prolactin receptor signaling in disease.

About endometriosis

Endometriosis is a chronic estrogen-dependent gynecological disease defined by the presence of endometrial-like tissue outside the uterus, which induces a chronic inflammatory reaction. The endometrium is a layer of mucous tissue that lines the uterine cavity and undergoes hormone-dependent changes during the menstrual cycle. Endometriosis is a common disease in women of childbearing age. The prevalence is estimated at 10% among women of reproductive age worldwide. Lower abdominal and pelvic pain, menstrual cramps (dysmenorrhea), painful intercourse (dyspareunia), and infertility are well-known symptoms of endometriosis. Asian women have been reported to have a higher prevalence of endometriosis than Caucasians and African Americans. A recent study found that the prevalence was higher among Filipino, Indian, Japanese, and Korean women (15.7%) compared to Caucasian women (5.8%). Endometriosis is generally 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. Generally, there are two types of interventions: treatment of pain and treatment of infertility associated with endometriosis.

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”, “conceive”, “perform”, “assess”, “expect”, “predict”, “target”, “goal” and any other similar word or phrase, where all references to the company are intended to be identified 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 obligation to publicly announce to update or revise any forward-looking statement.

SOURCEHope Medicine Inc.