HKBU plans trial for ulcerative colitis remission drug in 2025

It will be randomised, double-blind, and placebo-controlled.

The Centre for Chinese Herbal Medicine Drug Development (CDD) at Hong Kong Baptist University plans to launch a Phase II clinical trial for its new drug, CDD-2103, in mainland China next year.

Designed for patients with ulcerative colitis showing symptoms of spleen deficiency and internal damp-heat accumulation, the Chinese formulation seeks to maintain remission, an area where existing treatments fall short.

The team's clinical study showed that patients who used the drug in a decoction format tolerated it well, with no reported adverse effects.

The trial, aimed at verifying the drug's safety and effectiveness in maintaining remission, will be randomised, double-blind, and placebo-controlled.

The CDD expects to complete larger-scale trials within the next five years. Once sufficient data is collected, the centre will apply for new drug approval from the National Medical Products Administration to bring the drug to market.