AffaMed Therapeutics (“AffaMed”), a global clinical stage biopharmaceutical company dedicated to addressing critical unmet medical needs in ophthalmic, neurological and psychiatric disorders, today announced that it has successfully completed the first patient dosing in Mainland China as part of the global Phase IIb multi-center clinical trial of AM006 for early Parkinson's disease ("early PD"). As a Phase IIb clinical study conducted simultaneously in in Greater China and Southeast Asia, the trial aims to investigate the efficacy and safety of the dopamine agonist AM006 in patients with early PD.
Dr. Dayao Zhao, CEO of AffaMed commented, "By within a short timeframe securing approval to initiate the Phase IIb clinical trial for AM006 and successfully completing first patient dosing in Mainland China, this important milestone in the company's first multi-regional clinical trial (MRCT) serves to demonstrate the strength and efficiency of our development team. We look forward to AM006 continuing the encouraging therapeutic potential shown in its prior studies, and becoming a new treatment option for early-stage Parkinson's disease patients in China and globally soon."
Previously, AM006 demonstrated favorable safety and pharmacodynamic results in Phase I and Phase IIa clinical studies for the treatment of early PD in Japan. The results of these studies showed that AM006 has a good safety and pharmacokinetic profile in healthy subjects and patients with early PD at a dose up-titration, and its incidence of adverse events such as sleep disturbance and somnolence was significantly lower than that of pramipexole extended-release tablets.
Based on pharmacokinetic data from 176 subjects in the AM006 Phase I and Phase IIa clinical trials in Japan, AffaMed is conducting a randomized, placebo-controlled, double-blind, dose-titration study simultaneously in Greater China (Mainland China, Taiwan, Hong Kong, and Macau), and Southeast Asia (Singapore, Malaysia, Thailand, Indonesia, Vietnam, and the Philippines). Approximately 160 patients with early PD will be enrolled in the study and randomized to receive AM006 or placebo dosing after passing a screening period.
AM006 is in global Phase IIb stage of clinical development, with CTA’s approved in Singapore in April 2021, and Mainland China and Taiwan in May 2021.