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Lilly's (LLY) Alzheimer Drug Fails Late-Stage Prevention Study

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Eli Lilly (LLY - Free Report) announced that the phase III A4 study evaluating its candidate, solanezumab, in people with preclinical Alzheimer's disease (AD)failed to achieve its primary and secondary endpoints. Preclinical AD refers to those patients who have not shown any AD symptoms but have an amyloid plaque.

Data from the A4 study, which evaluated solanezumab in preclinical AD patients, showed that treatment with the drug did not slow cognitive decline or reduce the risk of progression to symptomatic AD. The treatment, designed to target soluble amyloid beta proteins, did not result in the clearance of amyloid plaque. Amyloid is a key driver of cognitive decline in AD indication.With the A4 study failing to meet the primary and secondary endpoints, Lilly has stopped the clinical development of solanezumab for Alzheimer’s prevention.

Based on the above data, management concluded that unlike solanezumab, a more aggressive form of treatment is needed, which removes deposited amyloid plaques even at the very early stage of AD indication.

Solanezumab has failed in previous studies. In one such case, in 2016, solanezumab failed to slow disease progression in a late-stage study in patients with mild dementia due to AD.

In the year so far, shares of Eli Lilly declined 14.6% compared with the industry’s 8.8% fall.

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Apart from solanezumab, Lilly is evaluating other AD candidates like donanemab and remternetug in ongoing late-stage clinical studies.

Earlier this January, Lilly announced that the FDA had issued a complete response letter (“CRL”) to its regulatory filing seeking accelerated approval for donanemab. Per the FDA, the CRL was issued as the study supporting the regulatory filing had limited information on patients who received at least 12 months of continued treatment on donanemab. The CRL specifically requested Lilly to provide data from at least 100 patients with at least 12 months of exposure to donanemab.

Based on the responses received in the CRL, Lilly is working closely with the FDA to evaluate the fastest pathway to resolve the FDA’s queries. Management expects to report topline data from the phase II TRAILBLAZER-ALZ study later this year and file for standard approval by mid-2023.

The AD target market is highly competitive as several other pharma companies like Biogen (BIIB - Free Report) and Roche (RHHBY - Free Report) have their drugs targeting the AD indication.

In January, the FDA approved Biogen/Eisai’s Leqembi (lecanemab) under the accelerated approval pathway for treating early AD. The approval was based on data from a mid-stage study which showed that treatment with the Biogen drug reduced the accumulation of amyloid beta (Aβ) plaque in the brain. Biogen/Eisai priced Leqembi at a wholesale acquisition cost (WAC) of $26,500 per year. Earlier this month, Biogen announced that the FDA had accepted a regulatory filing seeking traditional approval for the drug in the same indication.

Last November, Roche announced the failure of the GRADUATE I and II studies, evaluating its monoclonal antibody gantenerumab in early AD. Both studies failed to meet their primary endpoint of slowing clinical decline. Patients treated with Roche’s gantenerumab showed a slowdown of clinical decline in GRADUATE I and GRADUATE II, which was not statistically significant. Per Roche, the level of beta-amyloid removal was lower than expected.

In a separate press release, Eli Lilly also announced that the FDA had accepted a regulatory filing seeking label expansion for its blockbuster drug Jardiance for lowering blood sugar (along with diet and exercise) in children aged 10 years and older with type II diabetes. The drug is already approved for use in the same indication in adults aged 18 years and older.

 

Zacks Rank & Stocks to Consider

Eli Lilly currently carries a Zacks Rank #4 (Sell).

A better-ranked stock in the overall healthcare sector is Novo Nordisk (NVO - Free Report) , which sports a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.

In the past 30 days, estimates for Novo Nordisk’ 2023 earnings per share have risen from $4.20 to $4.43. During the same period, the earnings for 2024 have risen from $4.90 to $5.19. Shares of Novo Nordisk have risen 4.5% in the year-to-date period.

Earnings of Novo Nordisk beat estimates in three of the last four quarters while missing the mark on one occasion, witnessing an earnings surprise of 3.00%, on average. In the last reported quarter, Novo Nordisk’ earnings beat estimates by 2.47%.

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