In one-year update, Alzheon goes big talk, but shows off little clinical data
As Biogen pulls its global Aduhelm applications left and right, Alzheon — another smaller Massachusetts-based biotech — claims (again) it has “industry-leading” data on its Alzheimer’s drug. In a field littered with drug failures, any clinical benefit would be a major breakthrough. But on that front, Alzheon came up empty-handed.
In a one-year update on its Phase II trial, Alzheon said that in 75 patients who took its oral drug ALZ-801 twice a day, it observed a 41% reduction from baseline in levels of phosphorylated tau, or p-tau, a brain protein which builds up in Alzheimer’s disease. Alzheon also said that its drug reduced the ratio of p-tau and a component of amyloid plaques, Aβ42, by 37%.
Alzheon’s Phase II trial enrolled 84 patients with early Alzheimer’s who have either one or two copies of a specific genotype — APOE4 — which is a genetic risk factor for Alzheimer’s.
But notably, Alzheon provided no clinical data in its one-year update. It only said that memory test scores were “maintained above baseline at 1-year timepoint,” but failed to provide any specific numbers or statistics. Alzheon did not respond to request for comment at the time of publication.
In its six-month study update in February, Alzheon likewise did not give exact numbers on memory test data, saying only that there was an improvement from baseline at 26 weeks with a p-value of 0.002.
Alzheon’s drug, like others before it, is built on the amyloid hypothesis — the idea that Alzheimer’s can be treated by removing the brain protein plaques that are a signature of the disease.
But that hypothesis has continuously floundered in clinical tests. Aduhelm’s controversial approval lies in two supposedly identically-designed Phase III studies that had conflicting clinical results.
In April, Alzheon raised $50 million as part of its Series D. The big test for Alzheon is its NIH-funded Phase III study on ALZ-801 — a 300-patient study in which success rides on real clinical improvement.