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Lilly (LLY) Down as Alzheimer's Drug Fails Investor Expectation
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Shares of Eli Lilly (LLY - Free Report) fell more than 9% on Mar 15 after it announced data on secondary endpoints of its phase II study — TRAILBLAZER-ALZ. Earlier in January, the company had announced that the study, which evaluated its antibody candidate, donanemab, in patients with early symptomatic Alzheimer's disease (“AD”), has met its primary endpoint. However, the latest data on certain secondary endpoints failed to meet the expectations of investors, which led to the decline in the stock.
Lilly’s shares have gained 12.1% so far this year against the industry’s decline of 0.6%.
Data from the study, announced in January, showed that treatment with donanemab slowed disease progression significantly by 32% compared to placebo, as measured on the integrated Alzheimer's Disease Rating Scale (iADRS), over a treatment period of 76 weeks. The measurement on iADRS, a novel and composite measure of cognition and daily function, was the primary endpoint of the study.
Updated data from the study announced last week showed consistent slowing of cognitive and functional decline as measured by Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) and Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog13) during the final analysis. These two scales are more widely used measurements for Alzheimer's disease patients and were included in the study’s secondary endpoints. Although treatment with donanemab consistently slowed the decline as measured on these two scales and achieved nominal statistical significance multiple times compared to placebo during the study, it failed to maintain the statistical significance during the final analysis after 76 weeks of treatment.
The company and the investors diverge on the analysis of the data, as Lilly is focusing on the iADRS while the investors chose the widely-accepted CDR-SB and ADAS-Cog13 scales for their understanding.
Moreover, investors are skeptical about the iADRS measurement due to Lilly’s past performance with its discontinued AD candidate, solanezumab. This candidate also performed better when measured in iADRS, but CDR-SB scores were not that encouraging. The candidate failed in the late-stage study.
Meanwhile, Lilly believes that donanemab holds potential as a therapy for treating AD patients as it consistently slowed cognitive and functional decline across all primary and secondary endpoints. The company also defended its usage of iADRS as the primary endpoint instead of the CDR-SB scale by stating that it believes iADRS to be a more consistent and sensitive measure to detect treatment differences than other Alzheimer's disease scales.
The company is also evaluating the candidate in a pivotal phase II study — TRAILBLAZER-ALZ 2. Following the TRAILBLAZER-ALZ study data readout, the company is changing the study designation to phase III and increasing the enrollment target to 1,000. It is also changing the primary endpoint of the study to iADRS from the current CDR-SB scale. The company shifted the CDR-SB scale to the secondary endpoints list.
Future, data readouts from the TRAILBLAZER-ALZ 2 study will provide more clarity on the potential of donanemab as an AD therapy. However, AD is one of the toughest diseases to be treated. While there is no cure for the disease yet, there are a few drugs approved by the FDA that can help control the symptoms of AD. One of the leading contenders in the AD segment is Biogen’s (BIIB - Free Report) controversial investigational treatment for Alzheimer’s disease — aducanumab — which is under review with the FDA. A decision is expected this month. We note that an FDA advisory committee has voted against approving aducanumab last year in November. Several other companies have terminated their AD programs after years of failure, including Merck (MRK - Free Report) and Pfizer (PFE - Free Report) .
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Lilly (LLY) Down as Alzheimer's Drug Fails Investor Expectation
Shares of Eli Lilly (LLY - Free Report) fell more than 9% on Mar 15 after it announced data on secondary endpoints of its phase II study — TRAILBLAZER-ALZ. Earlier in January, the company had announced that the study, which evaluated its antibody candidate, donanemab, in patients with early symptomatic Alzheimer's disease (“AD”), has met its primary endpoint. However, the latest data on certain secondary endpoints failed to meet the expectations of investors, which led to the decline in the stock.
Lilly’s shares have gained 12.1% so far this year against the industry’s decline of 0.6%.
Data from the study, announced in January, showed that treatment with donanemab slowed disease progression significantly by 32% compared to placebo, as measured on the integrated Alzheimer's Disease Rating Scale (iADRS), over a treatment period of 76 weeks. The measurement on iADRS, a novel and composite measure of cognition and daily function, was the primary endpoint of the study.
Updated data from the study announced last week showed consistent slowing of cognitive and functional decline as measured by Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) and Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog13) during the final analysis. These two scales are more widely used measurements for Alzheimer's disease patients and were included in the study’s secondary endpoints. Although treatment with donanemab consistently slowed the decline as measured on these two scales and achieved nominal statistical significance multiple times compared to placebo during the study, it failed to maintain the statistical significance during the final analysis after 76 weeks of treatment.
The company and the investors diverge on the analysis of the data, as Lilly is focusing on the iADRS while the investors chose the widely-accepted CDR-SB and ADAS-Cog13 scales for their understanding.
Moreover, investors are skeptical about the iADRS measurement due to Lilly’s past performance with its discontinued AD candidate, solanezumab. This candidate also performed better when measured in iADRS, but CDR-SB scores were not that encouraging. The candidate failed in the late-stage study.
Meanwhile, Lilly believes that donanemab holds potential as a therapy for treating AD patients as it consistently slowed cognitive and functional decline across all primary and secondary endpoints. The company also defended its usage of iADRS as the primary endpoint instead of the CDR-SB scale by stating that it believes iADRS to be a more consistent and sensitive measure to detect treatment differences than other Alzheimer's disease scales.
The company is also evaluating the candidate in a pivotal phase II study — TRAILBLAZER-ALZ 2. Following the TRAILBLAZER-ALZ study data readout, the company is changing the study designation to phase III and increasing the enrollment target to 1,000. It is also changing the primary endpoint of the study to iADRS from the current CDR-SB scale. The company shifted the CDR-SB scale to the secondary endpoints list.
Future, data readouts from the TRAILBLAZER-ALZ 2 study will provide more clarity on the potential of donanemab as an AD therapy. However, AD is one of the toughest diseases to be treated. While there is no cure for the disease yet, there are a few drugs approved by the FDA that can help control the symptoms of AD. One of the leading contenders in the AD segment is Biogen’s (BIIB - Free Report) controversial investigational treatment for Alzheimer’s disease — aducanumab — which is under review with the FDA. A decision is expected this month. We note that an FDA advisory committee has voted against approving aducanumab last year in November. Several other companies have terminated their AD programs after years of failure, including Merck (MRK - Free Report) and Pfizer (PFE - Free Report) .
Eli Lilly and Company Price
Eli Lilly and Company price | Eli Lilly and Company Quote
Zacks Rank
Lilly currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Zacks Top 10 Stocks for 2021
In addition to the stocks discussed above, would you like to know about our 10 best buy-and-hold tickers for the entirety of 2021?
Last year's 2020Zacks Top 10 Stocks portfolio returned gains as high as +386.8%. Now a brand-new portfolio has been handpicked from over 4,000 companies covered by the Zacks Rank. Don’t miss your chance to get in on these long-term buys.
AccessZacks Top 10 Stocks for 2021 today >>