Eli Lilly Shares Higher on Alzheimer’s Drug!

Eli Lilly TRAILBLAZER-ALZ 2 met primary endpoint, all secondary endpoint

Eli Lilly (LLY) announced results of the TRAILBLAZER-ALZ 2 Phase 3 study showing that donanemab significantly slowed cognitive and functional decline in people with early symptomatic Alzheimer’s disease.

Eli Lilly announces Alimta label expanded by FDA, Stockwinners

Donanemab met the primary endpoint of change from baseline until 18 months on the integrated Alzheimer’s Disease Rating Scale, or iADRS.

The primary endpoint of iADRS measures cognition and activities of daily living such as managing finances, driving, engaging in hobbies, and conversing about current events.

All secondary endpoints of cognitive and functional decline were also met and showed highly statistically significant clinical benefits with similar magnitude.

Based on these results, Lilly will proceed with global regulatory submissions as quickly as possible and anticipates making a submission to the FDA yet this quarter.

Lilly will work with the FDA and other global regulators to achieve the fastest path to traditional approvals.

TRAILBLAZER-ALZ 2, a randomized, double-blind, placebo-controlled study, evaluated the safety and efficacy of donanemab, an investigational amyloid plaque targeting therapy.

The study enrolled people with early symptomatic Alzheimer’s disease, or AD, which includes mild cognitive impairment, or MCI, and the mild dementia stage of disease, with the confirmed presence of AD neuropathology, and participants completed their course of treatment with donanemab once they reached a prespecified level of amyloid plaque clearance.

Biogen sharply higher on data, Stockwinners

Participants in TRAILBLAZER-ALZ 2 were stratified by their level of the brain protein tau, a predictive biomarker for Alzheimer’s disease progression. The primary analysis population for which the study was powered was comprised of people with an intermediate level of tau and clinical symptoms of Alzheimer’s disease.

In this population, the primary endpoint (iADRS) showed 35% slowing of decline, and an important key secondary endpoint showed 36% slowing of decline over 18 months.

Additional pre-specified secondary analyses showed: 47% of participants on donanemab showed no decline on CDR-SB, a key measure of disease severity at 1 year. 52% of participants completed their course of treatment by 1 year and 72% completed by 18 months as a result of achieving plaque clearance.

Participants on donanemab had 40% less decline in ability to perform activities of daily living at 18 months. Participants on donanemab experienced a 39% lower risk of progressing to the next stage of disease compared to placebo.

The study also enrolled a smaller number of people with high levels of tau at baseline, representing a later stage of disease progression.

Because these participants were predicted to progress more quickly and be less responsive to therapy, the target population for the study was the intermediate tau population. The high tau participants were combined with the intermediate tau population in an additional primary analysis of all participants enrolled. In this combined population, donanemab also demonstrated meaningful positive results across all clinical endpoints, with CDR-SB and iADRS showing 29% and 22% slowing of decline, respectively. The incidence of amyloid-related imaging abnormalities was consistent with the TRAILBLAZER-ALZ Phase 2 study.

Infusion-related reactions occurred in 8.7% of participants with most cases mild to moderate in severity. In addition to slowing cognitive and functional decline in TRAILBLAZER-ALZ 2, donanemab produced significant reductions in brain amyloid plaque levels as early as 6 months after initiating treatment, as observed using amyloid positron emission tomography brain scan, with many patients reaching amyloid levels considered negative for pathology1.

Alzheimer’s disease is a progressive brain disorder that affects memory, thinking, and behavior. According to the World Health Organization (WHO), around 50 million people worldwide have dementia, and the most common cause of dementia is Alzheimer’s disease.

In the United States, it is estimated that around 6 million people have Alzheimer’s disease. This number is expected to increase as the population ages.

The economic effect of Alzheimer’s disease is significant. According to the Alzheimer’s Association, in 2021, the total cost of caring for people with Alzheimer’s and other dementias in the United States is projected to reach $355 billion. This includes the cost of medical care, long-term care, and lost wages for family caregivers. By 2050, these costs are projected to increase to $1.1 trillion.

The economic impact is not just limited to the United States. Alzheimer’s disease has a global economic impact, with estimated costs of around $1 trillion in 2018. As the population ages, the economic impact is expected to increase.

LLY shares are up $25 to $429.15 or 6% on the day. Shares of Biogen (BIIB) which has a competing drug are down $5 to $310.03.

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FDA Approves Biogen’s Alzheimer’s Drug

FDA approves Biogen Alzheimer’s drug, says benefits outweigh risks

The FDA approved Biogen’s (BIIB) Aduhelm to treat patients with Alzheimer’s disease.

“This approval is significant in many ways. Aduhelm is the first novel therapy approved for Alzheimer’s disease since 2003.

Perhaps more significantly, Aduhelm is the first treatment directed at the underlying pathophysiology of Alzheimer’s disease, the presence of amyloid beta plaques in the brain.

The clinical trials for Aduhelm were the first to show that a reduction in these plaques – a hallmark finding in the brain of patients with Alzheimer’s – is expected to lead to a reduction in the clinical decline of this devastating form of dementia,” the FDA said in a statement.

Eli Lilly announces Alimta label expanded by FDA, Stockwinners
Eli Lilly is a partner with Biogen

It added, “We ultimately decided to use the Accelerated Approval pathway – a pathway intended to provide earlier access to potentially valuable therapies for patients with serious diseases where there is an unmet need, and where there is an expectation of clinical benefit despite some residual uncertainty regarding that benefit.

Brain of an Alzheimer patient

In determining that the application met the requirements for Accelerated Approval, the Agency concluded that the benefits of Aduhelm for patients with Alzheimer’s disease outweighed the risks of the therapy.”

The FDA said in its approval statement: “Additionally, FDA is requiring Biogen to conduct a post-approval clinical trial to verify the drug’s clinical benefit. If the drug does not work as intended, we can take steps to remove it from the market. But hopefully, we will see further evidence of benefit in the clinical trial and as greater numbers of people receive Aduhelm. As an agency, we will also continue to work to foster drug development for this catastrophic disease.”

STIFEL

Stifel analyst Paul Matteis reiterates his Buy rating on Biogen shares following the FDA granting accelerated approval of aducanumab, now to be called “Aduhelm,” for the treatment of Alzheimer’s disease.

Approval based on amyloid plaque as a “surrogate” is “definitely unexpected” and appears to be a way for FDA to work around the contentious advisory committee meeting, argues Matteis, who adds that the approval “is a big win.” How investors will risk-adjust revenues that are modeled after completion of a Phase 4 trial and how insurers will treat access for a drug approved based on a biomarker are “highly interesting” questions that will now “be debated at a materially higher stock valuation,” added Matteis. Biogen shares remain halted for trading at midday following news of the FDA approval.

JEFFRIES

Jefferies analyst Andrew Tsai said news of Biogen (BIIB) being granted FDA approval for aducanumab is likely to spark investor enthusiasm across all Alzheimer’s names and he believes the longer-term setup for Athira Pharma (ATHA) looks more attractive now. Given what he views as “the FDA tailwind,” he would buy on strength as he believes the FDA’s aducanumab decision “clearly has a positive readthrough” to Athira, whose Phase I data suggests ATHA-1017 could produce “a profound cognitive benefit” in Phase 2/3 studies expected to read out in 2022, Tsai tells investors.

In that context, he thinks a 25%-50% short-term move for Athira shares “seems reasonable” relative to the company’s current market cap.

Shares of Biogen (BIIB) remain halted while Eli Lilly (LLY), who has an Alzheimer’s disease drug in its pipeline, is up 4% to $210.78 following the news.

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