Alpha Cognition, a biopharmaceutical company, 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 (AD).
The company elected to conduct this additional study, which was designed to demonstrate pharmacokinetic (PK) equivalence between 5mg ALPHA-1062 delayed release tablets and 8 mg galantamine hydrobromide extended release (ER) capsules. These data, coupled with positive data released in June, establish bioequivalence to both formulations of galantamine hydrobromide and strengthen the NDA application for ALPHA-1062 in mild-to-moderate AD, planned for Q2 2023.
The study was a two-treatment, two-period, crossover study wherein 40 subjects were randomly assigned 1:1 to either treatment with ALPHA-1062 5mg twice daily, or galantamine hydrobromide 8mg ER capsules once daily, for 7 days. After a one-week washout period, subjects were then crossed over to the other treatment arm and dosed for 7 days.
Topline results confirmed that in healthy adult volunteers treated to steady state, ALPHA-1062 was bioequivalent to galantamine hydrobromide ER. 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 ER. As expected, Cmax results for ALPHA-1062 is bracketed between galantamine hydrobromide IR and ER (lower than IR, higher than ER) providing a robust and enhanced data set for the NDA filing. These data further describe the delayed release profile of ALPHA-1062 and strengthen the NDA data set by characterizing the therapeutic and acceptable exposures compared to both the immediate release and extended release products.