Alpha Cognition announces positive results from study of AD therapeutic
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Alpha Cognition Inc. has announced positive results from a bioequivalence study with Alpha-1062, a proprietary, delayed release oral tablet formulation in development for the treatment of mild to moderate Alzheimer’s disease.
According to a release issued by Alpha, topline results confirmed that in healthy adult volunteers treated to steady state, Alpha-1062 was bioequivalent to galantamine hydrobromide extended-release capsules. In the pre-specified primary analysis, Alpha-1062 achieved area-under-the-curve and peak exposures of approximately 107% and 127%, respectively, compared to those generated by galantamine hydrobromide extended-release capsules.
The study was a two-treatment, two-period, crossover study with 40 participants randomly assigned on a 1:1 basis to either 5 mg of Alpha-1062 twice daily, or 8 mg of galantamine hydrobromide 8 mg extended-release capsules once daily, for 7 days. After a 1-week washout period, subjects were then crossed over to the other treatment arm and dosed for 7 days.
“We are delighted with these additional positive registrational bioequivalence results from our second study of our lead asset, Alpha-1062, which further strengthens our NDA filing,” Cedric O’Gorman, MD, chief medical officer of Alpha Cognition, said in the release. “ALPHA-1062, a prodrug of galantamine, was designed to limit gastrointestinal side effects and, if approved, could provide a meaningful advancement for patients with Alzheimer’s.”
The company elected to conduct this additional study, which was designed to demonstrate pharmacokinetic equivalence between 5 mg Alpha-1062 delayed release tablets and 8 mg galantamine hydrobromide extended-release capsules, per the release.
These data, coupled with the positive pivotal data released in June, established bioequivalence to both formulations of galantamine hydrobromide and strengthened the new drug application for Alpha-1062 in mild to moderate AD, planned for the second quarter of 2023, according to the release.