Will Biogen’s aducanumab become the first drug approved to slow progression of Alzheimer’s disease? Biogen’s licensing application for the biologic ran into headwinds at a U.S. Food and Drug Administration advisory committee meeting held November 6. It was led by the agency’s Billy Dunn, who directs development of new neurology treatments (Nov 2020 news). The agency’s internal biostatistical and neurologic reviews presented starkly opposing views of the efficacy data—the former critical, the latter glowing. This disconnect consternated both the committee and the many scientists listening to the public proceedings from around the country.

Cognoptix, a leading diagnostics company dedicated to early detection of Alzheimer's disease (AD), announced today the formation of its new Scientific Advisory Board (SAB) with appointment of five world-class scientists and clinical researchers in AD. The SAB includes Jeffrey L. Cummings, MD, ScD; Lee E. Goldstein, MD, PhD; Philip Scheltens, MD, PhD; Martin R. Farlow, MD; and Carl H. Sadowsky, MD. Drs. Cummings and Goldstein will serve as SAB Clinical and Science Chairs, respectively.

A new Chinese therapy for Alzheimer’s is embarking on a much-anticipated U.S. study -- the latest bid to revive hopes in the multibillion-dollar search for an effective medicine against the incurable disease.

EIP Pharma, Inc. (www.eippharma.com), a CNS-focused therapeutics company, today announced that the Phase 2 AscenD-LB study in patients with mild-to-moderate dementia with Lewy bodies (DLB) met its primary endpoint of demonstrating an improvement in cognition as assessed by the Neuropsychological Test Battery (NTB). In the double-blind placebo-controlled study, patients receiving neflamapimod three times daily (TID) demonstrated significant improvement on the NTB compared to those who received either placebo or neflamapimod twice daily (BID); p=0.015, effect size (Cohen's d)=0.52. In addition, statistically significant improvements (p<0.05) or trends (p<0.1) were evident on multiple secondary clinical endpoints. The full results have been accepted as a late-breaking abstract and will be shared on November 7, 2020 during an oral presentation at the 13th Clinical Trials in Alzheimer's Disease (CTAD) meeting.

Today's Daily Dose brings you news about Gilead's acquisition of Immunomedics, Marinus' CDKL5 deficiency disorder trial results, Seattle Genetics' oncology collaborations with Merck, 89bio's NASH trial data, and Cassava Sciences' Alzheimer's trial results.

Today's Daily Dose brings you news about Gilead's acquisition of Immunomedics, Marinus' CDKL5 deficiency disorder trial results, Seattle Genetics' oncology collaborations with Merck, 89bio's NASH trial data, and Cassava Sciences' Alzheimer's trial results.

The Alzheimer's Foundation of America (AFA) will be holding a free, virtual continuing medical education (CME) program for physicians on Thursday, September 10th from 12 pm to 2:30 pm (ET). Physicians can register by clicking here.

Alzheimer's disease has been an unsolved puzzle for scientists since the first patient was found over 100 years ago. Different theories like cholinergic hypothesis, amyloid cascade hypothesis, and tau protein hypothesis have made progress in research but failed to bring new therapies to patients. In recent years scientists started to focus on the brain-gut axis, with its breakthrough in the fields of Parkinson's disease, depression and autism. Data linking the microbiome to Alzheimer's disease and GV-971 targeting the brain-gut axis launched by Shanghai Green Valley Pharmaceuticals were presented at the 34th Alzheimer's Association International Conference (AAIC).