Chinese biopharmaceutical company Shanghai Zhimeng Biopharma Inc ('Zhimeng') announced on Friday the start of the phase 2/3 clinical trial of the company's self-developed new-generation potassium channel opener CB03-154 for the treatment of amyotrophic lateral sclerosis (ALS).

CB03-154 has been granted orphan drug status in the United States in October 2023 for the treatment of ALS.

This phase 2/3 clinical trial, a multicentre, randomised, double-blind, placebo-controlled study with open-label extension, will enrol approximately 240 patients diagnosed with ALS in about 15 centres in China.

Focusing on patients within 24 months of the first symptom onset, the study's primary efficacy endpoint is the change from baseline at week 39 of the revised ALS Functional Rating Scale (ALSFRS-R) score.