Amid an influx of new drugs targeting one of the believed root causes of Alzheimer’s disease, a new symptomatic med has hit the scene, courtesy of Vancouver’s Alpha Cognition.
On Monday, the FDA gave a thumbs up to Alpha Cognition’s galantamine prodrug benzgalantamine to treat mild-to-moderate Alzheimer’s disease.
The med, which is taken orally twice a day and will be sold under the brand name Zunveyl, comes at a starting dose of 5 mg. Patients will eventually move up to a 10 mg maintenance dose and can increase their dose to a maximum of 15 mg, according to the company.
As a prodrug of the well-established Alzheimer’s med galantamine, Zunveyl remains inert as it passes through the stomach, helping to prevent unpleasant side effects associated with the original drug such as nausea, vomiting and decreased appetite. Some 55% of Alzheimer’s disease patients discontinue their medication after one year, due in large part to gastrointestinal side effects and insomnia, according to Alpha Cognition.
Zunveyl is believed to help tackle Alzheimer’s disease symptoms on two fronts. First, the drug helps prevent the breakdown of acetylcholine, the neurotransmitter involved in memory, motivation and attention functions, Alpha Cognition explained in a release.
Secondly, the drug helps stimulate the release of acetylcholine from presynaptic neurons, the company said.
“We have always believed in the efficacy of galantamine but have been limited in its use due to tolerability issues,” Elaine Peskind, M.D., Friends of Alzheimer’s Research Professor of Psychiatry at the University of Washington School of Medicine, said in a statement. “To now have an agent with the efficacy of galantamine, but that also offers the hope of better tolerability, will provide physicians a great option to treat patients.”
Zunveyl snagged its approval thanks in part to data showing its bioequivalence and tolerability versus galantamine in both immediate- and extended-release formulations.
Alpha Cognition specifically ran three bioavailability studies in healthy adults comparing galantamine immediate- and extended-release tablets to Zunveyl. The trials found that the company’s drug did not cause insomnia and led to less than 2% of patients developing GI side effects.
In terms of launch plans, Alpha Cognition says it aims to make Zunveyl available in pharmacies across the U.S. starting in the first quarter of 2025. Zunveyl will mark Alpha Cognition’s first commercial product.
The oral med’s approval comes during something of a renaissance in the world of Alzheimer’s treatment.
Starting with the ill-fated approval of Eisai and Biogen’s Aduhelm in 2021, several new drugs, including the partners’ Alzheimer’s successor Leqembi and, most recently, Eli Lilly’s Kisunla, have emerged to fight back against the debilitating neurodegenerative disease.
Unlike Zunveyl, which targets the symptoms of Alzheimer’s disease, Leqembi and Kisunla attempt to slow the progression of the disease by purging beta-amyloid proteins from the brain. Beta amyloids can build up over time, and they are believed to clog and slow the network of cells responsible for memory and thinking.