Bioavailability and Bioequivalence Study Results
Alpha Cognition, Inc. (OTC:ACOGF) provided topline results from its bioavailability and bioequivalence (BABE) study in a June 22nd press release which was followed by a conference call providing additional detail along with a presentation summarizing key data. Results showed that Alpha-1062 (galantamine benzoate) presented a favorable side effect profile and was within the parameters for bioavailability and bioequivalence required by the FDA to grant approval via the 505(b)(2) regulatory pathway. Next steps are to prepare for the safety and tolerability study that will measure overall adverse events and specific side effects. The trial, designated RESOLVE, will be designed as a three arm study comparing two arms of Alpha-1062 with placebo and enrolling 300 patients. Based on the data that is being developed, a New Drug Application (NDA) is expected to be filed for Alpha-1062 in Alzheimer’s Disease (AD) by 2Q:23.
The two objectives of the BABE trial were to measure whether or not the bioequivalence of Alpha-1062 compared with the reference product fell within the limits required for Area Under the Curve (AUC) and maximum plasma concentration (CMAX). During the June 22nd conference call, Chief Medical Officer Cedric O’Gorman, M.D. provided a summary of the data generated from the studies which we include below. The bioequivalence limits given compare Alpha-1062 with galantamine hydrobromide immediate release formulation.
The data provided in the release support continued development of Alpha-1062. The safety profile of the drug was excellent with no serious adverse events (SAEs) in the active arm. The control arm evaluating galantamine hydrobromide IR was associated with two SAEs including diarrhea and vomiting, which were in-line with expectations based on the label for the reference drug. The main objective of Alpha-1062 with its prodrug formulation and enteric coating is to avoid many of the side effects common to approved formulations of galantamine which frequently cause patients to stop taking the drug, thereby failing to obtain its benefits. If Alpha Cognition’s formulation of the drug can address these shortcomings, it is likely that the benefits that we elucidate in our initiation will be more broadly available for Alzheimer’s patients.
Alpha-1062 Pivotal Bioavailability/Bioequivalence Study Background
Alpha Cognition launched its pivotal bioavailability and bioequivalence studies in 2Q:22, each of which enrolled 36 healthy adult subjects. Both studies were of an open label, balanced, randomized, single dose, two-period, two-way crossover design. The study design called for a single dose of Alpha-1062 delayed release under both fed and fasted conditions. The hurdle for bioequivalence calls for a 90% confidence interval for pharmacokinetic parameters and area under the curve (AUC) and CMAX to fall between 80% and 125% of the standard.
Alpha Cognition Milestones
➢ Introduction of Alpha-0702 & -0802 – June 2022
➢ Alpha-1062 pivotal trial results in AD – 2Q:22
➢ FDA meeting to discuss ongoing development of Alpha-1062 – mid-2022
➢ Alpha-1062 patient tolerability study start in AD – 3Q:22
➢ Additional data sets for GEMs – 3Q:22
➢ Alpha-0602 pre-clinical study (2nd mammal) start – 3Q:22
➢ IND submission for Alpha-1062 in mild TBI – 4Q:22
➢ NDA submission for Alpha-1062 in AD – 2Q:23
➢ Alpha-0602 2nd mammal pre-clinical study top-line results – 2Q:23
➢ Alpha-1062 patient tolerability study topline results in AD – 2H:23
➢ Alpha-1062 potential label change – 4Q:23
➢ Initiation of Alpha-1062 combination (BABE) study – 4Q:23
➢ Alpha-1062 potential FDA approval for mild to moderate AD – 1Q:24
➢ Commercial launch of Alpha-1062 in mild to moderate AD – 1Q:24
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1. Source: June 2022 Alpha Cognition Corporate Presentation.
2. Source: June 2022 Alpha Cognition Corporate Presentation.
3. Source: June 2022 Alpha Cognition Corporate Presentation.