HONG
KONG, Sept. 4, 2024 /PRNewswire/ -- The Centre
for Chinese Herbal Medicine Drug Development (CDD) at Hong
Kong Baptist University (HKBU) has
achieved a significant milestone in developing a novel Chinese
herbal formulation for ulcerative colitis remission
maintenance. Following a submission of Investigational New Drug
application for CDD-2103 to the National Medical Products
Administration (NMPA) in mid-June this year, CDD has received
in late August its authorisation for clinical trial.
CDD plans to commence a Phase II clinical trial for this
new drug in the Mainland next year to
verify its effectiveness and safety as a treatment for
remission maintenance for ulcerative colitis.
Developed based on traditional Chinese
medicine formulation
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 include diarrhea,
rectal bleeding and abdominal cramps, resulting in a reduced
quality of life for patients. Ulcerative colitis can be
broadly divided into active and remission stages. Currently the
main treatment objectives 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 relieve ulcerative
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 a clinical study conducted in Hong
Kong by 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
granule in 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
improving the tolerogenic immune microenvironment, which is
achieved by mediating the differentiation of regulatory T
cells and reducing the number of inflammatory macrophages in
the colon, as well as strengthening the tight junction
proteins in the mucosal barriers. The research findings have
been published in a number of scientific
journals including Journal of Advanced Research,
Phytomedicine and 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 is optimistic
that it can improve patients' quality of life. CDD-2103 is a
novel Chinese herbal formulation developed based on the
modified ancient formulations combined with modern
technology. Obtaining clinical trial approval from
NMPA for this new drug is one of the important milestones of
the Centre, which is also a recognition of the efforts of
the research team in the development of novel Chinese
herbal drugs."
Phase II trial focuses on safety and effectiveness
CDD will launch a randomised, double-blind, and
placebo-controlled clinical trial in the Mainland in 2025 to
evaluate the drug's safety and
effectiveness in ulcerative colitis patients in
remission.
Dr Tan Hor Yue, Assistant
Professor of CDD stated: "It is anticipated that the larger scales
of clinical trials will be completed in the next five years in
order to confirm CDD-2103's therapeutic effect and safety
in treating ulcerative colitis. After collecting sufficient
data regarding the drug's safety and efficacy, the Centre will
submit an application for NMPA's new drug approval, with the
objective of obtaining authorisation for the sales of
CDD-2103 in the market".
CDD, located in the Hong Kong Science Park, is funded by
the Innovation and Technology Commission's InnoHK initiative.
It is the only centre focusing on the research and development
of Chinese herbal medicines at 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.
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SOURCE Hong Kong Baptist
University