News

UK regulators grant innovation passport to AD04 for Alzheimer’s

An innovation passport, the first step in the U.K.’s Innovative Licensing and Access Pathway (ILAP) — intended to accelerate the development and approval of new therapies that address an unmet medical need — has been awarded to AD04, ADvantage Therapeutics’ investigational immunotherapy for mild Alzheimer’s disease. The designation, granted…

BIIB080 shows Alzheimer’s-related tau protein reduction in study

Treatment with the experimental therapy BIIB080 led to long-term reductions in the levels of disease-associated tau protein in the brains of people with early Alzheimer’s disease. That’s according to new data from a Phase 1b trial (NCT03186989) presented by Biogen at the International Conference on Alzheimer’s and Parkinson’s…

FDA poised to decide on traditional approval of Leqembi in July

The U.S. Food and Drug Administration (FDA) has agreed to review a request to convert Leqembi’s (lecanemab) accelerated approval to a traditional approval for treating Alzheimer’s disease. The FDA has granted priority review to the supplemental biologics license application (sBLA) and the agency is expected to make a…

Most doctors in survey favor DISCERN to diagnose Alzheimer’s

DISCERN, a biomarker test reported to accurately diagnose Alzheimer’s disease at its earliest stages, routinely would be used by 90% of physicians who responded to a recent survey. With a positive test using a small skin sample, physicians were some six times more likely to diagnose Alzheimer’s and nearly three times…

INTERCEPT-AD trial of ACU193 for early Alzheimer’s ends enrollment

The Phase 1 INTERCEPT-AD trial testing the investigational antibody ACU193 in patients with early Alzheimer’s disease has now completed enrollment, according to its developer, Acumen Pharmaceuticals. Top-line results, including safety and proof-of-concept mechanism data, are expected ahead of schedule in the third quarter of this year. “Today’s…