Alpha Cognition Inc. (formerly Neurodyn Cognition) and CRO Linical have announced Linical will provide consulting services related to potential development of Alpha Cognition’s Alpha-1062 acetyl choline esterase inhibitor (AChEI) for the treatment of Alzheimer’s disease. Linical’s services are expected to encompass a range of areas, including regulatory guidance, clinical trial support, and post-marketing programs.
Both oral and intranasal formulations of Alpha-1062 are in development with the goal of regulatory approval in the US by early 2023, followed by Japanese approval. Based on FDA and PDMA guidance, pivotal clinical trials may be initiated in both the US and Japan by the end of this year, the companies said. Alpha Cognition suggests that the drug may also be useful for other conditions, including Huntington’s disease and schizophrenia.
According to Alpha Cognition, Phase 1 and 1b trials of intranasal Alpha-1062 previously demonstrated that doses of the formulation resulted in 90% fewer gastro-intestinal adverse events than similar dose levels of Razadyne, an oral AChEI already approved for the treatment of Alzheimer’s.
Linical Accelovance America CEO Vita Lanoce commented, “Alpha Cognition’s program marks an exciting milestone in the field of Alzheimer’s research. Alpha-1062 is poised to fill the need for a more effective drug with less side effects in Alzheimer’s patients. We look forward to working with Alpha Cognition on their complete development program in the US and Japan, and we see the potential of this therapy in applications beyond Alzheimer’s disease.”
Alpha Cognition CEO Ken Cawkell said, “We selected Linical to be our drug development partner for this program because of their strong footprint in Japan and the US, as well as their robust clinical trials program. I was impressed with the organization’s capabilities in CNS clinical research and their attentiveness to our needs.”
Read the Linical and Alpha Cognition press release.
