Alpha Cognition has reported positive data from a bioequivalence study of a delayed release oral tablet formulation, ALPHA-1062, being developed to treat patients with mild to moderate Alzheimer’s disease (AD).
The two-treatment, two-period, crossover study enrolled a total of 40 participants.
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These subjects were randomised into a 1:1 ratio to receive either a 5mg twice-a-day dose of ALPHA-1062 or galantamine hydrobromide 8mg extended-release (ER) capsules once a day for a total of seven days.
Following a one-week washout period, participants were subsequently crossed over to the other group and received the treatment for seven days.
The study has been designed to establish the pharmacokinetic (PK) equivalence of 5mg ALPHA-1062 delayed-release tablets, with 8mg galantamine hydrobromide ER capsules.
According to the topline data, steady state, ALPHA-1062 was bioequivalent to galantamine hydrobromide ER in healthy adult subjects.
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By GlobalDataALPHA-1062 attained nearly 107% and 127% area-under-the-curve and peak exposures, respectively, against galantamine hydrobromide ER-generated levels in the initial assessment.
As anticipated, Cmax data for ALPHA-1062 is positioned between galantamine hydrobromide IR and ER, i.e., less than IR and greater than ER, providing a strong data set for the submission of a New Drug Application (NDA).
These findings, along with the previously reported positive results, establish bioequivalence of ALPHA-1062 to IR and ER formulations of galantamine hydrobromide and will be used to file an NDA for mild-to-moderate AD in the second quarter of next year.
A new chemical entity, ALPHA-1062 is in the development stage as a new generation acetylcholinesterase inhibitor, with reduced gastrointestinal side effects to treat AD.
Alpha Cognition chief medical officer Cedric O’Gorman said: “We have successfully demonstrated that ALPHA-1062 is bioequivalent to two different release formulations of galantamine hydrobromide, the immediate-release and the extended-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 disease.”
