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AffaMed Therapeutics, a clinical-stage innovative biomedical company dedicated to meeting the global needs for the treatment of ophthalmology, neurological and psychiatric diseases, today announced that the National Medical Products Administration (NMPA) has approved the global IIb clinical trial application (CTA) led by it.
To evaluate the safety and effectiveness of AM006 for the treatment of patients with early Parkinson's disease (PD)
.
AM006 is a new type of non-ergot dopamine receptor agonist (DA), which can be clinically developed to improve PD symptoms by stimulating striatal dopamine receptors
PD is a common clinical degenerative disease of the nervous system, which mainly manifests as motor symptoms such as resting tremor, bradykinesia, muscle rigidity and postural balance disorders, as well as non-motor symptoms such as emotional and cognitive dysfunction
.
The exact cause of PD is currently unknown.
Dr.
Dayao Zhao, CEO of AffaMed, said: “In China and around the world, patients with Parkinson’s disease have a huge demand for treatment
.
We are very pleased to advance AM006’s NMPA clinical trial within 7 months after signing the product license agreement.
AM006 is an innovative drug with great potential to treat PD
.
The results of previous studies suggest that the drug may reduce the risk of certain adverse reactions (such as valvular heart disease, drowsiness, sudden sleep and impulse control disorders) that have been reported by existing DA
Globally, AM006 is in the IIb clinical trial phase, and the clinical application for this project has been approved in Singapore and China in April and May 2021, respectively