Biogen ( BIIB Quick Quote BIIB - Free Report) and partner Eisai recently announced that their big global phase III confirmatory study, Clarity AD, on investigational anti-amyloid beta protofibril antibody candidate lecanemab (BAN2401) for treating early Alzheimer’s Disease (AD), met the primary endpoint. Shares of BIIB surged 39.85% in response to the news.
Lecanemab met the primary endpoint of CDR-SB: Clinical Dementia Rating-Sum of Boxes (the numeric scale used to quantify the various severity of symptoms of dementia). All key secondary endpoints were also achieved with highly statistically significant results. The study's success is a landmark and has boosted investor sentiment.
Eisai plans to file for traditional approval of lecanemab in the United States and submit regulatory applications in Europe and Japan by the end of the first quarter of 2023.
Eli Lilly ( LLY Quick Quote LLY - Free Report) and clinical stage biotech Prothena ( PRTA Quick Quote PRTA - Free Report) , which have promising AD candidates in their pipeline, also witnessed a price surge following the positive data as investors became optimistic about the success of their candidates.
Lilly was up 7.5% on Biogen’s data. It is evaluating donanemab, an investigational antibody that targets a modified form of beta-amyloid called N3pG for treating AD. The candidate is under priority review in the United States for AD under the accelerated approval pathway. Given the success of Biogen/Eisai’s AD candidate, the chances of Lilly’s AD drug approval have become high.
Prothena shares skyrocketed 87% on the same. The company is evaluating PRX012, an investigational high-potency monoclonal antibody targeting a key epitope at the N-terminus of amyloid beta (Aβ) for treating AD.
Prothena is also evaluating PRX005 in collaboration with Bristol Myers. PRX005 — a potential treatment for AD — is an investigational antibody that targets tau, a protein implicated in diseases including AD, frontotemporal dementia, progressive supranuclear palsy, chronic traumatic encephalopathy and other tauopathies.
The company is also developing a dual Aβ-Tau vaccine — a potential prevention and treatment for AD — to target key epitopes within Aβ and tau proteins to promote amyloid clearance and block pathogenic tau interaction. An investigational new drug (IND) application for the vaccine is anticipated in 2023.
Swiss pharma giant
Roche ( RHHBY Quick Quote RHHBY - Free Report) shares were up 6.9% on Sep 28 as it, too, is evaluating gantenerumab, an anti-amyloid beta antibody for AD. Roche has an extensive program for AD, including technology designed to more effectively detect and diagnose AD and monitor disease progression and multiple treatment approaches. Data from two phase III studies on gantenerumab for early AD are anticipated in November 2022.
AD is a progressive, fatal disease of the brain characterized by a decline in memory, language and other thinking skills, as well as changes in mood and behavior.
We remind investors that the FDA’s approval of Biogen’s and Eisai’s controversial AD drug, Aduhelm, in June 2021 put the spotlight on companies having promising AD candidates in their pipeline last year as well. The euphoria regarding Aduhelm, however, died down as the drug witnessed a slow launch due to reimbursement issues as its efficacy was under the scanner.
Nevertheless, despite the complexities associated with developing a treatment for AD and past failures, the space will continue to attract attention from pharma and biotech companies, given the significant unmet need.
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