- One of the most-watched Alzheimer’s therapies in the clinic, Biogen Inc BIIB–Eisai Limited’s 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 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 RHHBY-Market cap: $250 billion.
- Along with crenezumab, Roche is also evaluating gantenerumab in collaboration with MorphoSys AG 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 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 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 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 BMY.
AC Immune SA 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 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 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 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 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 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.
Image and article originally from www.benzinga.com. Read the original article here.