The US Food and Drug Administration (FDA) has accepted Alpha Cognition’s new drug application (NDA) for ALPHA-1062 to treat mild-to-moderate Alzheimer’s disease.

The regulatory agency will provide a decision on the approval of the treatment on 27 July 2024 under the Prescription Drug User Fee Act.

Alpha Cognition filed the NDA for ALPHA-1062 with the FDA in September 2023.

The filing is based on findings from four clinical trials that showed ALPHA-1062 to be bioequivalent to galantamine and galantamine ER.  

Adverse events associated with ALPHA-1062 in these studies were reported to be under 2%. Insomnia was not noted among them.

Alpha Cognition CEO Michael McFadden stated: “The FDA’s acceptance of our NDA for ALPHA-1062 brings us another significant step closer to delivering a much-needed treatment to patients suffering from Alzheimer’s disease.

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“We look forward to continuing our collaboration with the FDA throughout the review process.”

The clinical-stage biopharmaceutical company focuses on the development of therapies for treating neurodegenerative diseases such as Alzheimer’s and cognitive impairment with mild traumatic brain injury (mTBI).

A delayed-release oral tablet formulation, ALPHA-1062 is in development as a new-generation inhibitor of acetylcholinesterase.

The active metabolite of this new entity is differentiated from donepezil and rivastigmine as it attaches to the neuronal nicotinic receptors, especially to the alpha-7 subtype, which has a positive impact on cognition.

ALPHA-1062 is a pro-drug of galantamine and cuts down gastrointestinal-based adverse effects by remaining inert while passing through the stomach. 

Therapies currently approved for Alzheimer’s have substantial adverse events including nausea, diarrhoea and insomnia. 

Some patients therefore find them unpleasant and impractical to use over longer periods. This has led to an unmet need for effective and tolerable treatments for Alzheimer’s disease.

ALPHA-1062 is also being developed for use along with memantine for moderate to severe Alzheimer’s dementia and as an intranasal dose to treat cognitive impairment linked to mTBI.