HONG KONG,Sept. 4,2024 -- The Centre for Chinese Herbal Medicine Drug Development (CDD) atHong Kong Baptist University (HKBU) has achieved a significant milestone in developing a novel Chinese herbal formulation for ulcerative colitisremission maintenance. Following a submission of Investigational New Drug application for CDD-2103 tothe National Medical Products Administration (NMPA) in mid-Junethis year,CDD has received in late August its authorisationfor clinical trial.

(From right) Ms Emily Au,Assistant Director (Research and Development); Dr Tan Hor Yue,Assistant Professor; and Mr Duan Zhigang,Senior Regulatory Affairs Manager of CDD at HKBU,introduce the development of the novel Chinese herbal formulation for ulcerative colitis remission maintenance.

CDD plans to commencea Phase II clinical trial for this newdrug in the Mainland next year to verifyitseffectiveness and safety as a treatment for remission maintenance for ulcerative colitis.

Developedbased on traditional Chinese medicineformulation

Ulcerative colitis,a form of inflammatory bowel disease,is becoming increasingly prevalent. It has a rising morbidity particularly in China and other Asian countries. Its main symptoms includediarrhea,rectal bleeding and abdominal cramps,resulting in a reduced quality of life for patients. Ulcerative colitiscan be broadly divided into active and remission stages. Currently the main treatmentobjectives of the disease are to relieve symptoms,sustain the remission period,and reduce recurrence. Existing treatment options for ulcerative colitis cannot completely maintain remission,nor prevent its recurrence.

In search of more effective ways to relieveulcerative colitis,the research team developed a Chinese herbal formulation CDD-2103,with nine Chinese herbal medicines including Codonopsis Radix (dang shen) and Curcumae Longae Rhizoma (jiang huang),based on years of clinical experience. CDD-2103 is formulated for to maintain remission in ulcerative colitis patients who exhibit symptoms of spleen deficiency and internal accumulation of damp heat.

According to aclinical study conducted in Hong Kongby the research team,patients who used CDD-2103 in a decoction format demonstrated good tolerability with no adverse effects reported. The research team has developed the CDD-2103 granulein accordance with NMPA's stringent quality control standards,and completed a series of basic experimental studies including preclinical pharmaceutical,pharmacology and non-clinical safety evaluations. Results of the preclinical studies showed that CDD-2103 suppressed the progression of colitis by improvingthe tolerogenic immune microenvironment,which is achieved by mediatingthe differentiation ofregulatory T cellsand reducing the number of inflammatory macrophages in the colon,as well as strengthening thetight junction proteins in the mucosal barriers.The research findings have been published in a number ofscientific journalsincludingJournal of Advanced Research,Phytomedicineand Journal of Ethnopharmacology.

Professor Bian Zhaoxiang,Associate Vice-President (Clinical Chinese Medicine) and Director of CDD at HKBU,said: "We are delighted that CDD-2103 has obtained approval to carry out a Phase II clinical trial in the Mainland. The Centre isoptimistic that it canimprove patients' quality of life. CDD-2103 is a novel Chinese herbal formulation developed based onthe modified ancient formulations combined with modern technology.Obtaining clinical trial approval from NMPAfor this new drug is one of the important milestones of the Centre,which isalso a recognition ofthe efforts of the researchteam in the development of novel Chinese herbaldrugs."

Phase II trial focuses on safety and effectiveness

CDD willlaunch a randomised,double-blind,and placebo-controlled clinical trial in the Mainland in 2025 to evaluate the drug's safety and effectivenessinulcerative colitispatients in remission.

Dr Tan Hor Yue,Assistant Professor of CDD stated: "It is anticipated that the larger scales of clinical trials will be completed inthe next five years in order to confirm CDD-2103'stherapeutic effectand safety intreating ulcerative colitis. After collecting sufficient data regarding the drug's safety and efficacy,the Centre will submit an applicationfor NMPA's new drug approval,with the objective of obtainingauthorisation for the salesof CDD-2103 in the market".

CDD,located in the Hong Kong Science Park,isfunded by the Innovation and Technology Commission's InnoHK initiative. Itis the only centre focusing on the research and development of Chineseherbalmedicinesat a local university. Since its establishment in 2020,CDD has been focusing on innovative Chinese medicine research for gastrointestinal and immune-related diseases such as chronic constipation and ulcerative colitis.