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ALEC Stock Tanks as Alzheimer's Drug Fails in Mid-Stage Study
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Shares of Alector, Inc. (ALEC - Free Report) were down 35.1% on Nov. 26 after the company announced data from a mid-stage study that evaluated its pipeline candidate, AL002, for treating individuals with early Alzheimer’s disease (AD).
The phase II INVOKE-2 study evaluated the safety and efficacy of AL002 in slowing disease progression in individuals with early AD. The study's primary endpoint was to check disease progression, as measured by the Clinical Dementia Rating Sum of Boxes (“CDR-SB”) scale. The CDR-SB is a numerical scale that measures the severity of the AD indication.
In the study, treatment with AL002 failed to meet the primary endpoint of slowing Alzheimer’s clinical progression as measured by the CDR-SB. Also, no treatment effects favored AL002 on secondary clinical and functional endpoints in the INVOKE-2 study.
The stock hit its 52-week low on the pipeline setback. Year to date, shares of Alector have plunged 67.8% compared with the industry’s 7.8% decline.
Image Source: Zacks Investment Research
More on ALEC's INVOKE-2 Study
Data from the INVOKE-2 study demonstrated no significant effects on Alzheimer’s fluid biomarkers favoring AL002, as well as amyloid PET imaging showed no treatment-related reduction of brain amyloid levels.
Per the company, some positive signs were observed as treatment with AL002 resulted in sustained target engagement and pharmacodynamic responses indicative of microglial activation.
Based on the above study results, Alector has decided to discontinue the open-label extension study on the drug.
The company plans to share the data at a scientific conference in the future.
A humanized monoclonal antibody, AL002 targets triggering receptor expressed on myeloid cells 2 (“TREM2”) to improve cell survival and microglia activity.
ALEC's Plans for the Future
In light of the recent setback, Alector is focusing on developing other candidates for the treatment of neurodegenerative diseases. The company is developing latozinemab (AL001) and AL101/GSK4527226) in collaboration with GSK plc (GSK - Free Report) .
The phase III INFRONT-3 study is evaluating ALEC/GSK’s latozinemab for treating frontotemporal dementia with a progranulin gene mutation (FTD-GRN). Top-line data from the same is expected in late 2025 or early 2026.
Meanwhile, the phase II PROGRESS-AD is evaluating AL101/GSK4527226 for treating early AD. ALEC and GSK are making steady progress with this study, as more than one-third of the target enrollment has been reached.
To better align resources for its pipeline development and other strategic priorities, Alector has decided to reduce its current workforce by almost 17%.
As of Sept 30, 2024, the company’s cash, cash equivalents and investments were $457.2 million. Per management, this cash balance is likely to fund operations and provide runway through 2026.
Marketed Drugs in the AD Space
Currently, there are two drugs approved by the FDA in the AD space — Leqembi and Kisunla. Both these drugs are approved to treat early symptomatic AD, which includes mild cognitive impairment or mild dementia stage of the disease.
Leqembi, which was approved last year, is marketed by Japan-based Eisai in partnership with the Biogen (BIIB - Free Report) market. Kisunla was developed by Eli Lilly (LLY - Free Report) and received the FDA’s approval in July.
Eli Lilly and Biogen/Eisai drugs are based on similar mechanisms, reducing the accumulation of amyloid beta (Aβ) plaque in the brain. Aβ is a protein that is said to be the primary cause of the cognitive decline associated with Alzheimer’s disease.
Image: Bigstock
ALEC Stock Tanks as Alzheimer's Drug Fails in Mid-Stage Study
Shares of Alector, Inc. (ALEC - Free Report) were down 35.1% on Nov. 26 after the company announced data from a mid-stage study that evaluated its pipeline candidate, AL002, for treating individuals with early Alzheimer’s disease (AD).
The phase II INVOKE-2 study evaluated the safety and efficacy of AL002 in slowing disease progression in individuals with early AD. The study's primary endpoint was to check disease progression, as measured by the Clinical Dementia Rating Sum of Boxes (“CDR-SB”) scale. The CDR-SB is a numerical scale that measures the severity of the AD indication.
In the study, treatment with AL002 failed to meet the primary endpoint of slowing Alzheimer’s clinical progression as measured by the CDR-SB. Also, no treatment effects favored AL002 on secondary clinical and functional endpoints in the INVOKE-2 study.
The stock hit its 52-week low on the pipeline setback. Year to date, shares of Alector have plunged 67.8% compared with the industry’s 7.8% decline.
Image Source: Zacks Investment Research
More on ALEC's INVOKE-2 Study
Data from the INVOKE-2 study demonstrated no significant effects on Alzheimer’s fluid biomarkers favoring AL002, as well as amyloid PET imaging showed no treatment-related reduction of brain amyloid levels.
Per the company, some positive signs were observed as treatment with AL002 resulted in sustained target engagement and pharmacodynamic responses indicative of microglial activation.
Based on the above study results, Alector has decided to discontinue the open-label extension study on the drug.
The company plans to share the data at a scientific conference in the future.
A humanized monoclonal antibody, AL002 targets triggering receptor expressed on myeloid cells 2 (“TREM2”) to improve cell survival and microglia activity.
ALEC's Plans for the Future
In light of the recent setback, Alector is focusing on developing other candidates for the treatment of neurodegenerative diseases. The company is developing latozinemab (AL001) and AL101/GSK4527226) in collaboration with GSK plc (GSK - Free Report) .
The phase III INFRONT-3 study is evaluating ALEC/GSK’s latozinemab for treating frontotemporal dementia with a progranulin gene mutation (FTD-GRN). Top-line data from the same is expected in late 2025 or early 2026.
Meanwhile, the phase II PROGRESS-AD is evaluating AL101/GSK4527226 for treating early AD. ALEC and GSK are making steady progress with this study, as more than one-third of the target enrollment has been reached.
To better align resources for its pipeline development and other strategic priorities, Alector has decided to reduce its current workforce by almost 17%.
As of Sept 30, 2024, the company’s cash, cash equivalents and investments were $457.2 million. Per management, this cash balance is likely to fund operations and provide runway through 2026.
Marketed Drugs in the AD Space
Currently, there are two drugs approved by the FDA in the AD space — Leqembi and Kisunla. Both these drugs are approved to treat early symptomatic AD, which includes mild cognitive impairment or mild dementia stage of the disease.
Leqembi, which was approved last year, is marketed by Japan-based Eisai in partnership with the Biogen (BIIB - Free Report) market. Kisunla was developed by Eli Lilly (LLY - Free Report) and received the FDA’s approval in July.
Eli Lilly and Biogen/Eisai drugs are based on similar mechanisms, reducing the accumulation of amyloid beta (Aβ) plaque in the brain. Aβ is a protein that is said to be the primary cause of the cognitive decline associated with Alzheimer’s disease.
Alector, Inc. Price
Alector, Inc. price | Alector, Inc. Quote
ALEC's Zacks Rank
Alector currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.