The Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) has cleared Zhimeng Biopharma’s self-developed novel next-generation KCNQ2/3 potassium channel opener, CB03-154, to initiate a Phase-II clinical trial in China for refractory epilepsy. This follows the CDE's approval in July of this year for Phase-II/III clinical studies in Amyotrophic Lateral Sclerosis (ALS).

The upcoming trial is a randomised, double-blind, placebo-controlled, multi-national, multi-centre 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 demonstrates 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 the 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.

Dr Huanming Chen, Chief Executive Officer (CEO), Zhimeng Biopharma, stated, "Zhimeng has consistently focused on research in liver diseases and central nervous system disorders. From target exploration to molecule optimisation, from pharmaceutical research to pre-clinical evaluation, we have always advanced our projects with a scientifically rigorous attitude, ultimately gaining continuous recognition from regulatory agencies. Thanks to the team's efforts and the support of all investors and research institutions. We are committed to deepen our work in areas of unmet clinical need, progressing clinical trials in full speed and providing patients with safer and more effective treatment options.”