- One of the most-watched Alzheimer's therapies in the clinic, Biogen Inc (NASDAQ:BIIB)-Eisai Limited's (OTC:ESALY) experimental lecanemab reduced clinical decline on the scale by 27% compared to the placebo at 18 months in early Alzheimer's.
- In July 2022, the FDA accepted the marketing application for lecanemab under the accelerated approval pathway and granted a Priority Review. The PDUFA date is Jan. 6, 2023.
- Also Read: This Analyst Believes Biogen's Lecanemab Data Not 'Slam Dunk' For Complete CMS Approval.
- Several stocks related to Alzheimer's programs are gaining. SVB Leerink said these positive results would reinvigorate the Alzheimer's space.
Eli Lilly And Co (NYSE:LLY) - Market cap: $295 billion.
- Positive readthrough is expected from its anti-amyloid beta donamemab in the first half of 2023.
- In an exploratory analysis, the first analysis found that patients who received donanemab showed a more significant change in amyloid plaque levels, which was "highly associated with less cognitive decline."
Roche Holding AG (OTC:RHHBY)-Market cap: $250 billion.
- Along with crenezumab, Roche is also evaluating gantenerumab in collaboration with MorphoSys AG (NASDAQ:MOR) in autosomal dominant Alzheimer's disease, as well as for preventing sporadic Alzheimer's and treating early Alzheimer's in late-stage trials.
- Gantenerumab received FDA Breakthrough Designation.
Novo Nordisk A/S (NYSE:NVO)- Market cap: $215 billion.
- Oral semaglutide is currently in Phase 3 studies for early Alzheimer's disease that are expected to complete in 2025.
Cassava Sciences Inc (NASDAQ:SAVA) - Market cap: $1.85 billion
- Simufilam, Cassava's Alzheimer's candidate, is a small molecule (oral) drug that restores the normal shape and function of altered filamin A protein in the brain.
- Mired by controversy on fabricated data for the candidate. Recently received Journal of Prevention of Alzheimer's Disease said no evidence to support data manipulation allegations.
Prothena Corporation Plc (NASDAQ:PRTA) - Market Cap: $1.5 billion.
- Initiated a Phase 1 study of PRX012, a next-generation anti-amyloid beta (Aβ) antibody for Alzheimer's disease. PRX012 received FDA Fast Track designation.
- A Phase 1 study of PRX005, a humanized monoclonal antibody for Alzheimer's disease, in collaboration with Bristol Myers Squibb Co (NYSE:BMY).
AC Immune SA (NASDAQ:ACIU) - Market Cap: $255 million.
- Crenezumab is an investigational treatment discovered by AC Immune and designed to neutralize a pathological species of the beta-amyloid protein called oligomers.
- In June, disappointing data from a Phase 2 study was announced in collaboration with Roche.
Acumen Pharmaceuticals Inc (NASDAQ:ABOS) - Market cap: $190 million.
- ACU193 is an antibody against amyloid-beta oligomers for early Alzheimer's disease for the company listed in 2021.
- Topline results from INTERCEPT-AD Phase 1 trial are expected in 1H 2023.
- Phase 2/3 clinical trial preparation activities are progressing.
Alzamend Neuro Inc (NASDAQ:ALZN) - Market cap: $106 million.
- Lead product AL001. Data showed that salicylate plasma concentrations were well-tolerated and consistently within safe limits. In May 2022, Phase 2 multiple-ascending dose study was initiated in Alzheimer's patients.
Annovis Bio Inc (NYSE:ANVS) - Market Cap: $105 million.
- Buntanetap is the lead compound. It is in clinical trials for Parkinson's and Alzheimer's.
- Buntanetap-treated AD patients showed a statistically significant cognitive improvement of 30% compared with baseline results. Buntanetap is the only drug to improve cognition in AD patients and motor function in PD patients.
Longeveron Inc (NASDAQ:LGVN) - Market Cap: $85 million.
- In January, it initiated a Phase 2a trial evaluating Lomecel-B as a treatment for Alzheimer's disease (AD).
- The study is at the 50% enrollment threshold (n=24 patients randomized) and remains on track to complete enrollment by the end of 2022.
Cognition Therapeutics Inc (NASDAQ:CGTX) - Market cap: $37 million
- Recently, it presented a proteomic analysis of clinical biomarker data from the SPARC study of CT1812 in mild-to-moderate Alzheimer's disease. The candidate demonstrated the effect of CT1812 on multiple Alzheimer's biomarkers.
- Initiated dosing in Phase 2 SHINE study of CT1812 for mild-to-moderate Alzheimer's disease.
