Alpha Cognition's delayed-release Alzheimer's drug hits goal, teeing up approval filing

Alpha Cognition has taken another step toward a filing for approval of its delayed-release treatment for Alzheimer’s disease, publishing top-line results from a study that compared the prospect to an incumbent product.

The asset, ALPHA-1062, is a delayed-release prodrug formulation of galantamine, a reversible inhibitor of acetylcholinesterase that is used to treat the symptoms of Alzheimer’s. Because galantamine can cause gastrointestinal adverse events including nausea, vomiting and decreased appetite, Alpha Cognition sees a market for a prodrug formulation that remains inert as it passes through the stomach.

Work to show that ALPHA-1062 can fill the perceived gap in the market has advanced in recent months, with Alpha Cognition posting data from one study in June and following up with the results of another trial this week. 

“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. We have successfully demonstrated that ALPHA-1062 is bioequivalent to two different release formulations of galantamine hydrobromide, the immediate release and the extended release,” Cedric O’Gorman, M.D., chief medical officer of Alpha Cognition, said in a statement.

The most recent clinical trial to deliver data randomly assigned 40 subjects to receive ALPHA-1062 or an extended-release formulation of galantamine. After taking the assigned capsules once a day for seven days, participants stopped dosing and, after a washout period, started taking the other medicine.

Alpha Cognition found ALPHA-1062 to be bioequivalent to the galantamine formulation. The area under the curve and peak exposures for the investigational product were 107% and 127%, respectively, of the figures for galantamine. Armed with the data, the company plans to submit a new drug application in the second quarter of next year.