Chinese biopharmaceutical company Shanghai Zhimeng Biopharma Inc announced on Thursday that its self-developed novel next-generation KCNQ2/3 potassium channel opener, CB03-154, has recently received clinical trial approval from the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) to initiate a Phase 2 clinical trial in China for refractory epilepsy.

This follows the CDE's approval in July for Phase 2/3 clinical studies in amyotrophic lateral sclerosis (ALS). The upcoming trial is a randomised, double-blind, placebo-controlled, multinational, multicentre study designed to evaluate the clinical efficacy, safety, and tolerability of CB03-154 as an adjunctive therapy in adult patients (18-70 years old) with focal epilepsy.

CB03-154 is a novel next-generation KCNQ2/3 potassium channel opener developed by Zhimeng Biopharma. It is claimed to demonstrate good chemical and metabolic stability, in vitro and in vivo anti-epileptic activity/efficacy, pharmacokinetic properties, and safety. It also possesses more specific ion channel selectivity, potentially overcoming the safety issues associated with first-generation drugs. Currently, clinical studies for CB03-154 in epilepsy are also underway in Australia.

Research suggests that KCNQ2/3 potassium channel openers could be effective not only for epilepsy but also for major depressive disorder (MDD), ALS, and neuropathic pain. Previously, CB03-154 tablets had also been granted Orphan Drug Designation (ODD) by the US FDA for development in the treatment of ALS patients.