China’s Shanghai Ark Biopharmaceutical Co., Ltd. has announced the completion of a Phase III study evaluating the efficacy, safety, and tolerability of its AK0901 in Chinese children aged 6-12 with Attention Deficit Hyperactivity Disorder (ADHD). The trial successfully achieved both primary and key secondary endpoints, demonstrating statistical significance at all visiting time points compared to placebo.
Drug Profile and Mechanism
AK0901, licensed from Swiss firm Commave Therapeutics, SA, is a novel methylphenidate-based drug combining immediate-release dexmethylphenidate (d-MPH) and the prodrug serdexmethylphenidate (SDX). It works by inhibiting the reuptake of dopamine and norepinephrine in the synaptic cleft, thereby enhancing neurotransmitter efficiency to alleviate ADHD symptoms. This combination makes AK0901 the first and only drug of its kind.
Clinical Trial Success
The Phase III trial’s success marks a significant milestone for Shanghai Ark Biopharmaceutical. The positive results position AK0901 as a promising treatment option for ADHD, a chronic neurodevelopmental disorder characterized by attention deficits and/or hyperactivity-impulsivity that often persists into adulthood.
Market Potential and Future Steps
Approved in the US in March 2021, AK0901 represents the first new-generation methylphenidate drug in nearly two decades. Shanghai Ark Biopharmaceutical secured development and marketing rights through a USD 105.5 million licensing deal with Commave in December 2021. The company is likely to use these positive Phase III results to support future regulatory submissions and market expansion in China.-Fineline Info & Tech
Leave a Reply