Biotech
Friday, December 8th, 2023 4:41 pm EDT
Key Points
FDA Acceptance of ALPHA-1062 New Drug Application (NDA):
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- The United States Food and Drug Administration (FDA) has completed the review and accepted Alpha Cognition Inc.’s NDA for ALPHA-1062, a delayed release oral tablet formulation developed for mild-to-moderate Alzheimer’s disease.
- The NDA has been assigned a Prescription Drug User Fee Act (PDUFA) goal date, set for July 27th, 2024, indicating a significant milestone in the regulatory process.
Basis of NDA Submission and Clinical Studies:
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- The NDA submission is supported by findings from four studies conducted by Alpha Cognition, demonstrating bioequivalence of ALPHA-1062 to galantamine and galantamine ER.
- Adverse events associated with ALPHA-1062 across all studies were reported to be less than 2%, and notably, no cases of insomnia were observed. These results contribute to the safety profile of the drug.
Alpha Cognition’s Commitment to Neurodegenerative Diseases:
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- Alpha Cognition Inc. is a clinical-stage biopharmaceutical company dedicated to developing treatments for neurodegenerative diseases, including Alzheimer’s disease and Cognitive Impairment with mild Traumatic Brain Injury (mTBI), where currently no approved treatment options exist.
- ALPHA-1062, the company’s proprietary new chemical entity, acts as an acetylcholinesterase inhibitor with an expected minimal gastrointestinal side effect profile. It targets nicotinic receptors, particularly the alpha-7 subtype, known to positively impact cognition. ALPHA-1062 is also being explored for combination therapy and as an intranasal formulation for different cognitive conditions.
The United States Food and Drug Administration (FDA) has completed its filing review and has accepted Alpha Cognition Inc.’s new drug application (NDA) for ALPHA-1062, a proprietary, patented, delayed release oral tablet formulation in development for the treatment of mild-to-moderate Alzheimer’s disease. The NDA has been granted a Prescription Drug User Fee Act (PDUFA) goal date of July 27th, 2024.
The NDA submission is based on results from four studies the Company conducted demonstrating bioequivalence for ALPHA-1062 to galantamine and galantamine ER. Adverse events documented across all studies for ALPHA-1062 were less than 2% and no insomnia was observed.
“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,” said Michael McFadden, Chief Executive Officer of Alpha Cognition. “We look forward to continuing our collaboration with the FDA throughout the review process.”
About Alpha Cognition Inc.
Alpha Cognition Inc. is a clinical stage, biopharmaceutical company dedicated to developing treatments for patients suffering from neurodegenerative diseases, such as Alzheimer’s disease and Cognitive Impairment with mild Traumatic Brain Injury (“mTBI”), for which there are currently no approved treatment options.
ALPHA-1062, is a patented new chemical entity being developed as a new generation acetylcholinesterase inhibitor for the treatment of Alzheimer’s disease, with expected minimal gastrointestinal side effects. ALPHA-1062’s active metabolite is differentiated from donepezil and rivastigmine in that it binds neuronal nicotinic receptors, most notably the alpha-7 subtype, which is known to have a positive effect on cognition. ALPHA-1062 is also being developed in combination with memantine to treat moderate to severe Alzheimer’s dementia, and as an intranasal formulation for Cognitive Impairment with mTBI.
