Alector Announces Results from AL002 INVOKE-2 Phase 2 Trial in Individuals with Early Alzheimer’s Disease and Provides Business Update
Alector announced disappointing results from its INVOKE-2 Phase 2 trial of AL002 for early Alzheimer's disease. The drug failed to meet its primary endpoint of slowing disease progression and showed no significant effects on secondary endpoints or biomarkers. While AL002 achieved target engagement, it did not demonstrate treatment benefits and showed ARIA-related safety concerns. Following these results, Alector is discontinuing the long-term extension study and reducing its workforce by 17%. The company will focus on other programs, including the INFRONT-3 Phase 3 trial of latozinemab and PROGRESS-AD Phase 2 trial of AL101/GSK4527226. With $457.2 million in cash reserves, Alector expects runway through 2026.
Alector ha annunciato risultati deludenti dal suo studio di fase 2 INVOKE-2 su AL002 per l'Alzheimer in fase iniziale. Il farmaco non è riuscito a raggiungere il suo obiettivo primario di rallentare la progressione della malattia e non ha mostrato effetti significativi sugli endpoint secondari o sui biomarcatori. Anche se AL002 ha raggiunto l'impegno target, non ha dimostrato benefici nel trattamento e ha mostrato preoccupazioni per la sicurezza correlate all'ARIA. A seguito di questi risultati, Alector sta interrompendo lo studio di estensione a lungo termine e riducendo la sua forza lavoro del 17%. L'azienda si concentrerà su altri programmi, inclusi lo studio di fase 3 INFRONT-3 su latozinemab e lo studio di fase 2 PROGRESS-AD su AL101/GSK4527226. Con 457,2 milioni di dollari in riserve di liquidità, Alector prevede di avere risorse fino al 2026.
Alector anunció resultados decepcionantes de su ensayo de fase 2 INVOKE-2 de AL002 para la enfermedad de Alzheimer en etapas tempranas. El fármaco no cumplió con su objetivo primario de ralentizar la progresión de la enfermedad y no mostró efectos significativos en los puntos finales secundarios o en los biomarcadores. Aunque AL002 logró la participación objetivo, no demostró beneficios en el tratamiento y mostró preocupaciones de seguridad relacionadas con ARIA. Tras estos resultados, Alector está descontinuando el estudio de extensión a largo plazo y reduciendo su fuerza laboral en un 17%. La compañía se centrará en otros programas, incluidos el ensayo de fase 3 INFRONT-3 de latozinemab y el ensayo de fase 2 PROGRESS-AD de AL101/GSK4527226. Con 457,2 millones de dólares en reservas de efectivo, Alector espera tener recursos hasta 2026.
Alector는 조기 알츠하이머병을 위한 AL002의 INVOKE-2 2상 시험에서 실망스러운 결과를 발표했습니다. 이 약물은 질병 진행 속도를 늦추는 주요 목표를 달성하지 못했고, 2차 목표나 바이오마커에 대한 의미 있는 효과도 나타내지 않았습니다. AL002가 목표 약물과의 연결에는 성공했지만, 치료 효과를 입증하지 못했으며 ARIA 관련 안전성 우려도 나타났습니다. 이러한 결과를 바탕으로 Alector는 장기 연장 연구를 중단하고 인력을 17% 줄일 예정입니다. 회사는 latozinemab의 INFRONT-3 3상 시험 및 AL101/GSK4527226의 PROGRESS-AD 2상 시험을 포함하여 다른 프로그램에 집중할 것입니다. 4억 5천7백 20만 달러의 현금 보유액으로 Alector는 2026년까지의 자원을 기대하고 있습니다.
Alector a annoncé des résultats décevants de son essai de phase 2 INVOKE-2 sur AL002 pour la maladie d'Alzheimer précoce. Le médicament n'a pas réussi à atteindre son objectif principal de ralentir la progression de la maladie et n'a montré aucun effet significatif sur les critères secondaires ou les biomarqueurs. Bien qu'AL002 ait atteint l'engagement cible, il n'a pas démontré de bénéfices thérapeutiques et a soulevé des préoccupations en matière de sécurité liées à l'ARIA. Suite à ces résultats, Alector interrompra l'étude d'extension à long terme et réduira son effectif de 17%. L'entreprise se concentrera sur d'autres programmes, y compris l'essai de phase 3 INFRONT-3 sur le latozinemab et l'essai de phase 2 PROGRESS-AD sur l'AL101/GSK4527226. Avec 457,2 millions de dollars de réserves de liquidités, Alector s'attend à avoir des ressources jusqu'en 2026.
Alector hat enttäuschende Ergebnisse aus seiner INVOKE-2-Phase-2-Studie zu AL002 für frühe Alzheimer-Krankheit bekannt gegeben. Das Medikament hat das Hauptziel, das Fortschreiten der Krankheit zu verlangsamen, nicht erreicht und zeigte keine signifikanten Effekte auf sekundäre Endpunkte oder Biomarker. Obwohl AL002 das Zielengagement erreichte, wurden keine Behandlungsvorteile nachgewiesen und es traten Sicherheitsbedenken im Zusammenhang mit ARIA auf. Nach diesen Ergebnissen wird Alector die Langzeitverlängerungsstudie einstellen und die Belegschaft um 17% reduzieren. Das Unternehmen wird sich auf andere Programme konzentrieren, einschließlich der INFRONT-3-Phase-3-Studie zu latozinemab und der PROGRESS-AD-Phase-2-Studie zu AL101/GSK4527226. Mit 457,2 Millionen Dollar an Barreserven erwartet Alector bis 2026 finanziell stabil zu bleiben.
- Strong cash position of $457.2 million providing runway through 2026
- PROGRESS-AD Phase 2 trial has reached over one-third enrollment target
- Ongoing development of proprietary blood-brain barrier technology platform (ABC)
- AL002 failed to meet primary endpoint in Phase 2 INVOKE-2 trial
- No positive treatment effects observed on secondary endpoints
- Safety concerns with ARIA-related imaging abnormalities
- 17% workforce reduction announced
- Long-term extension study discontinued
Insights
The failure of AL002 in the INVOKE-2 Phase 2 trial represents a significant setback for Alector's Alzheimer's program. The drug showed no meaningful clinical benefits across primary and secondary endpoints, including the critical CDR-SB measure and amyloid reduction. The presence of ARIA side effects without therapeutic benefit is particularly concerning.
However, the company's pipeline diversity and strong cash position of
The market impact is likely to be significant given that AL002 was a key program, but the company's financial runway through 2026 and diverse pipeline help mitigate long-term risks.
SOUTH SAN FRANCISCO, Calif., Nov. 25, 2024 (GLOBE NEWSWIRE) -- Alector, Inc. (Nasdaq: ALEC), a clinical-stage biotechnology company pioneering novel, genetically validated therapies for the treatment of neurodegenerative diseases, today announced results from the INVOKE-2 Phase 2 clinical trial evaluating the safety and efficacy of AL002 in slowing disease progression in individuals with early Alzheimer’s disease (AD). Treatment with AL002 resulted in sustained target engagement and pharmacodynamic responses indicative of microglial activation. However, AL002 failed to meet the primary endpoint of slowing of Alzheimer’s clinical progression as measured by the Clinical Dementia Rating Sum of Boxes (CDR®-SB), and there were no treatment effects that favored AL002 on secondary clinical and functional endpoints. Similarly, there were no significant effects on Alzheimer’s fluid biomarkers favoring AL002, and amyloid PET imaging demonstrated no treatment-related reduction of brain amyloid levels. As previously reported, MRI changes resembling amyloid-related imaging abnormalities (ARIA) and infusion-related reactions were observed in INVOKE-2. The instances of ARIA were primarily seen in participants treated with AL002.
“We, at Alector, recognize the importance of advancing therapeutics to treat Alzheimer’s disease and remain committed in our mission to develop safe and effective treatments for the millions of people worldwide impacted by neurodegenerative diseases,” said Gary Romano, M.D., Ph.D., Chief Medical Officer at Alector. “With a robust dataset from the INVOKE-2 trial, we plan to further explore TREM2 biology. We extend our deepest gratitude to the dedicated investigators, patients and caregivers who made this important trial possible. We plan to share the results of the trial with the scientific community in the near future in the hopes of contributing to the understanding of AD pathophysiology and advancing effective therapeutics for this terrible disease.”
Based upon the results, Alector is stopping the long-term extension study.
Alector remains committed to advancing its mechanistically broad and genetically validated drug candidates for the treatment of neurodegenerative diseases. At the core of this effort are the company’s progranulin-elevating programs, latozinemab and AL101/GSK4527226, developed in collaboration with GSK. Topline data from the pivotal INFRONT-3 Phase 3 clinical trial of latozinemab in frontotemporal dementia with a progranulin gene mutation is expected in late 2025 or early 2026. PROGRESS-AD, a global Phase 2 clinical trial evaluating AL101/GSK4527226 in early AD, has reached more than one-third of its target enrollment of 282 participants. Alector is also advancing its preclinical candidates aimed at a broad and diverse range of protein and enzyme targets.
In addition to advancing its pipeline, the company is continuing to develop its proprietary and versatile blood-brain barrier technology platform, Alector Brain Carrier (ABC). ABC aims to enhance the delivery of therapeutic antibodies, proteins and enzymes, achieve deeper penetration and efficacy at lower doses, and ultimately improve patient outcomes while reducing costs.
To align resources with these strategic priorities, Alector is reducing its workforce by approximately
As of September 30, 2024, Alector has
About INVOKE-2
INVOKE-2 (Clinicaltrials.gov identifier NCT04592874), was a randomized, double-blind, placebo-controlled, dose-ranging, multi-center Phase 2 clinical trial evaluating the safety and efficacy of AL002 in slowing disease progression in individuals with early Alzheimer’s disease (AD). The trial, conducted at multiple sites across 11 countries, utilized a common close design with up to 96 weeks of randomized treatment, and all participants remained on their assigned regimen until the last participant completed 48 weeks of treatment. This design provided the opportunity to capture more observations for the primary analysis, with data collected at 48, 72, and 96 weeks. Patients were randomized to three dose regimens of AL002, 15mg/kg IV/q4w, 40mg/kg IV/q4w, 60mg/kg IV/q4w, or placebo.
About Alector
Alector is a clinical-stage biotechnology company that has pioneered immuno-neurology. The company has discovered and is developing a portfolio of mechanistically broad and genetically validated product candidates, including antibodies, protein and enzyme replacement therapies, for neurodegenerative diseases. Supported by biomarkers, Alector’s product candidates seek to treat a range of indications, including frontotemporal dementia, Alzheimer’s disease, and Parkinson's disease. Alector is also developing Alector Brain Carrier (ABC), a proprietary blood-brain barrier platform, which is being selectively applied to its next-generation product candidates and research pipeline. ABC aims to enhance the delivery of therapeutics, achieve deeper penetration and efficacy at lower doses, and ultimately improve patient outcomes while reducing costs. Alector is headquartered in South San Francisco, California. For more information, please visit www.alector.com.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements in this press release include, but are not limited to, statements regarding our business plans, workforce reduction, business strategy, product candidates, planned and ongoing preclinical studies and clinical trials, expected milestones, and expectations of our collaborations. Such statements are subject to numerous risks and uncertainties, including but not limited to risks and uncertainties as set forth in Alector’s Quarterly Report on Form 10-Q filed on November 6, 2024, with the Securities and Exchange Commission (“SEC”), as well as the other documents Alector files from time to time with the SEC. These documents contain and identify important factors that could cause the actual results for Alector to differ materially from those contained in Alector’s forward-looking statements. Any forward-looking statements contained in this press release speak only as of the date hereof, and Alector specifically disclaims any obligation to update any forward-looking statement, except as required by law.
Alector Contacts:
Alector
Katie Hogan
202-549-0557
katie.hogan@alector.com
1AB (media)
Dan Budwick
973-271-6085
dan@1abmedia.com
Argot Partners (investors)
Laura Perry
212-600-1902
alector@argotpartners.com
FAQ
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