Chronic constipation is a common gastrointestinal condition affecting approximately 14 percent of the global population. The Centre for Chinese Herbal Medicine Drug Development (CDD) of Hong Kong Baptist University (HKBU) announced on July 25 a significant breakthrough in developing innovative traditional Chinese medicine for treating chronic constipation. The Investigational New Drug Application submitted to the U.S. Food and Drug Administration (FDA) in April 2023 has been approved, paving the way for the commencement of phase one clinical trials this year. This marks the first time a traditional Chinese medicine developed in Hong Kong has received approval for clinical trials in the U.S.
Professor Bian Zhaoxiang, Associate Vice-President (Chinese Medicine Development), Director of the Clinical Division of the School of Chinese Medicine, and Director of the CDD at HKBU, stated that based on previous pilot clinical studies and foundational research on the traditional Chinese herbal formulation, “MaZiRenWan,“ they have developed the new drug ”CDD-2101“ targeted for the international market. The primary ingredients of ”CDD-2101” consist of six Chinese herbs: hemp seed, rhubarb, officinal magnolia bark, bitter apricot seed, bran stir-fried immature orange fruit, and white peony root.
The phase one clinical trial is set to begin in the U.S. this year, recruiting 20 healthy volunteers to participate in a randomized, double-blind, and placebo-controlled study. The trial will evaluate the drug’s safety, tolerability, and pharmacokinetics. Participants will be administered a single dose of “CDD-2101” or a placebo, and their clinical responses will be monitored for 24 hours.
The first phase of the clinical trial is expected to be completed by 2024, followed by phases two and three trials further to assess the therapeutic efficacy and safety of “CDD-2101.” These subsequent phases are projected to take 3 to 5 years. Afterward, the clinical trial data and details of drug production will be submitted to the U.S. FDA for the registration of the new medicine.
Professor Alexander Wai, President and Vice-Chancellor of HKBU, said that HKBU received funding from the Innovation and Technology Commission’s InnoHK initiative to establish the CDD in 2020, leading to the establishment of the CDD. The center has been focused on innovative research in traditional Chinese medicine for gastrointestinal and immunological conditions, including chronic constipation and ulcerative colitis.
