Baptist University Advanced a Botanical Drug to Phase I
Hong Kong Baptist University is set to conduct the first phase of clinical trials for a novel Chinese medicine targeting chronic constipation in the United States. This development comes after the US Food and Drug Administration (FDA) granted approval in April for the trial. The medicine, known as CDD-2101, represents a significant milestone as the first botanical drug developed in Hong Kong to undergo clinical trials in the US.
CDD-2101 is a product of the Centre for Chinese Herbal Medicine Drug Development at Baptist University, inspired by the traditional Chinese medicine formulation known as "MaZiRenWan," a widely used remedy for constipation. Its ingredients include hemp seed, rhubarb, officinal magnolia bark, bitter apricot seed, bran stir-fired immature orange fruit, and white peony root.
To meet the stringent quality control requirements of the US FDA for botanical drug development, the Baptist University's center has implemented enhanced quality control measures. Dr. Bian Zhaoxiang, the center's director and Baptist University's associate vice-president for Chinese medicine development, noted that there is a significant global demand for improved constipation treatments, and MZRW has demonstrated its effectiveness and safety.
Statistics reveal that up to 60 percent of the American population reports experiencing constipation over the past year, with approximately 14 percent suffering from chronic constipation lasting at least three months. Current treatments typically involve lifestyle and dietary adjustments, with laxatives prescribed if initial methods prove ineffective. However, many patients remain dissatisfied due to limited efficacy or adverse reactions.
Dr. Bian emphasized the positive results of clinical studies conducted in Hong Kong since 2006, confirming the safety and efficacy of MZRW, with no serious adverse events reported. The goal is to address the international market by combining traditional wisdom with modern technologies.
The journey of CDD-2101 began with a pre-investigational new drug meeting request submitted to the FDA in December 2021, ultimately leading to FDA authorization to conduct phase one clinical trials in April of the current year. The phase one trial is expected to commence later in the year and will involve twenty healthy American volunteers receiving one dose of CDD-2101 or a placebo, with 24-hour monitoring to assess safety, tolerability, and pharmacokinetics.
Subsequent phases will focus on patients with chronic constipation to gather safety and preliminary efficacy data (phase two) and test the medicine on a larger population to demonstrate its benefits and monitor adverse reactions (phase three). The entire process is estimated to span four to five years.
Dr. Bian expressed hopes that CDD-2101 will contribute valuable insights to the development of traditional Chinese medicine. The Centre for Chinese Herbal Medicine Drug Development was established in 2020 and received funding from the Innovation and Technology Commission's InnoHK initiative. Dr. Bian also expressed optimism about attracting investment from larger biomedical companies to support the project during phases two and three of the trials, further facilitating the development process.