Biogen BIIB along with partner Eisai announced that their large phase III confirmatory study, Clarity AD, on anti-amyloid beta protofibril antibody candidate lecanemab (BAN2401) to treat early Alzheimer’s disease (early AD), has met the primary endpoint
The Clarity AD study is evaluating lecanemab for the treatment of mild cognitive impairment (MCI) due to AD and mild AD (collectively known as early AD) with the confirmed presence of amyloid pathology in the brain.
Biogen claims that the study demonstrated a highly statistically significant reduction in clinical decline associated with the disease. The study’s primary endpoint was Clinical Dementia Rating-Sum of Boxes or CDR-SB, which is a numerical scale that measures the severity of symptoms of dementia. The study met the primary endpoint by showing that treatment with lecanemab in the early stages of the disease reduced the rate of clinical decline on the CDR-SB scale by 27% compared to placebo.
The study also met all key secondary endpoints, demonstrating highly statistically significant results. The incidence of amyloid-related imaging abnormalities (ARIA), a brain swelling side effect associated with anti-amyloid antibodies, was within management expectations.
Biogen’s stock was up 44.3% in pre-market trading on Wednesday in response to the positive data announcement. Biogen’s stock has declined 17.6% this year so far compared with a decrease of 28.9% for the industry.
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Biogen/Eisai have already filed their biologics license application (“BLA”), seeking accelerated approval for lecanemab with the FDA. The BLA was supported by data from a phase II study (Study 201). The FDA has accepted the BLA and granted priority review to the same. The FDA’s decision is expected on Jan 6, 2023.
Back then, Biogen had said that once data from the phase III confirmatory study, Clarity AD, is released, Eisai will seek full FDA approval for lecanemab based on data from the same, which will serve as a confirmatory study. Eisai plans to file for traditional approval of lecanemab in the United States and submit regulatory applications in the EU and Japan by the end of the first quarter of 2023.
Eisai plans to present the Clarity AD study results at the Clinical Trials on Alzheimer’s Congress to be held in November.
Biogen has developed lecanemab in collaboration with Eisai, with the latter leading the clinical development and regulatory submissions. The companies also developed another anti-amyloid antibody, Aduhelm, which was approved by the FDA in June 2021 but failed to generate meaningful sales.
Aduhelm’s FDA approval in June 2021 faced a lot of criticism about its mixed efficacy results, the FDA selection of the accelerated approval path and the regulatory process in general. The FDA approved Aduhelm despite an FDA advisory committee voting against its approval due to mixed outcomes data from ENGAGE and EMERGE phase III studies. All these issues affected demand, patient access and reimbursement for Aduhelm, which resulted in the slow launch.
In April 2022, The Centers for Medicare & Medicaid Services (“CMS”) released its final National Coverage Determination (“NCD”) decision for the class of anti-amyloid antibodies approved by the FDA, like Aduhelm. Per the final NCD decision, Medicare said it will cover FDA-approved drugs like Aduhelm only for patients enrolled in CMS-approved studies. The final NCD decision basically denied all Medicare beneficiaries access to Aduhelm, which reduced demand for Aduhelm to a minimal level. As a result of the NCD decision, Biogen decided to substantially wind down commercial operations for Aduhelm, retaining only minimal resources to manage patients’ access programs.
Aduhelm’s failure raised doubt over the mechanism of anti-amyloid beta antibodies. These antibodies target clearing the abnormal accumulation of Aβ protein in the brain. The accumulation of these sticky proteins is considered to be one of the main causes of Alzheimer’s disease. Biogen/Eisai believe the latest lecanemab Clarity AD study results prove the amyloid hypothesis.
Some other large-cap pharma giants like Roche RHHBY and Eli Lilly LLY are also developing their candidates targeting the AD indication. The Alzheimer’s candidates of these companies — also anti-amyloid beta antibodies — are in late-stage development or review and are expected to be launched in a few months.
Eli Lilly’s donanemab is also under priority review in the United States under the accelerated approval pathway for treating early AD. Lilly’s BLA seeking accelerated approval for donanemab was based on data from a mid-stage study — TRAILBLAZER-ALZ. Data from the study showed that donanemab slowed disease progression significantly by 32% compared to placebo in patients with early symptomatic AD.
Roche’s pipeline candidate for AD, gantenerumab, is an anti-amyloid beta antibody developed for subcutaneous administration. The candidate is currently being evaluated in the pivotal phase III GRADUATE 1 and 2 studies. Roche anticipates top-line data from both these studies in 2022. Last October, Roche announced that the FDA granted Breakthrough Therapy Designation to gantenerumab in AD.
Zacks Rank & Stocks to Consider
Biogen has a Zacks Rank #3 (Hold) currently. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
A better-ranked large drugmaker is Sanofi SNY, which has a Zacks Rank of 2 (Buy).
Earnings estimates for Sanofi have gone up from $4.06 per share to $4.14 per share for 2022 and from $4.23 to $4.29 per share for 2023 over the past 60 days. Sanofi’s stock has declined 25.8% this year so far.
Sanofi’s earnings beat estimates in all the last four quarters, delivering a surprise of 9.37%, on average.
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