On Thursday, Roche RHHBY and partner AC Immune ACIU announced data from an Alzheimer’s disease study on pipeline candidate, crenezumab, which showed that the treatment did not demonstrate a statistically significant clinical benefit. In the study, crenezumab failed to slow or prevent Alzheimer’s disease (AD) in cognitively unimpaired people who carry a specific genetic mutation, which causes the early onset of Alzheimer’s disease.
The study’s co-primary endpoints were assessing the rate of change in cognitive abilities or episodic memory function, measured by the API ADAD composite cognitive score and the Free and Cued Selective Reminding Test (FCSRT) Cueing Index. However, the study did not show a statistically significant clinical benefit in either of its co-primary endpoints. The study enrolled 252 members of a large extended family with Autosomal dominant AD in Colombia. Crenezumab was originally discovered by AC Immune.
AC Immune’s stock was down 17.8% on Thursday in response to the news. Roche/AC Immune’s Alzheimer candidate’s failure hurt the share price of Eli Lilly LLY and Biogen BIIB. Biogen was down 2.9% while Lilly declined 1.7%. These companies’ Alzheimer’s candidates — anti-amyloid beta antibodies — are in late-stage development and are expected to be launched in a few months.
Lilly has developed donanemab, an anti-amyloid beta antibody for AD. Lilly is continuing a rolling submission with the FDA, seeking approval for donanemab for early AD under the accelerated approval pathway based on data from TRAILBLAZER-ALZ. Lilly intends to complete the initial regulatory submission in this quarter and expects a potential regulatory decision in early 2023.
It expects a data readout from the TRAILBLAZER-ALZ 2 confirmatory phase III study on donanemab in 2023. If the data from this study is positive, it will become easier to meet the high level of evidence criteria set forth by The Centers for Medicare & Medicaid Services (“CMS”) in the final National Coverage Determination (NCD) decision released in April for the class of anti-amyloid antibodies approved by the FDA like Biogen’s 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 denies all Medicare beneficiaries access to Aduhelm, which will reduce future demand for the drug 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. The final NCD decision may also limit coverage for Lilly’s donanemab and Biogen/Eisai’s another Alzheimer’s candidate lecanemab, which may be approved by the FDA in the future.
Lecanemab, an anti-amyloid beta (Aβ) protofibril antibody, is being developed by Biogen in partnership with Japan’s Eisai. Eisai completed the rolling biologics license application (BLA) submission for lecanemab under the accelerated approval pathway in the United States in May. However, data from the phase III confirmatory study, Clarity AD, conducted with 1,795 patients, is expected to be released in fall 2022.
Data from the Clarity AD study can be later submitted to the FDA to verify the clinical benefit of lecanemab. Depending on data from the Clarity AD study, Eisai will seek full approval of lecanemab from the FDA in fiscal 2022.
Roche has another Alzheimer’s disease candidate in its pipeline, gantenerumab, also an anti-amyloid beta antibody. It is being evaluated for autosomal dominant Alzheimer’s disease, as well as for the prevention of sporadic Alzheimer’s and treatment of early Alzheimer’s in late-stage clinical studies. Results from the phase III GRADUATE studies of gantenerumab in early Alzheimer’s are expected in the fourth quarter of 2022.
It is expected that anti-amyloid beta antibodies have the potential to show some efficacy in early symptomatic Alzheimer’s patients. However, the failure of crenezumab to show a benefit in early-onset Alzheimer’s disease, a patient population in which anti-amyloid beta antibodies are expected to show some benefit, is yet another blow to pharmaceutical companies’ efforts to bring an effective treatment for this challenging disease.
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