Alector Completes Enrollment for Phase II Trial of Investigational Alzheimer’s Disease Therapy
The Phase II study, PROGRESS-AD, will evaluate the safety and efficacy of human monoclonal antibody AL101/GSK4527226 over 76 weeks.
Alector has announced the completion of enrollment for its Phase II clinical trial, PROGRESS-AD, evaluating the safety and efficacy of investigational human monoclonal antibody AL101/GSK4527226 in slowing disease progression in patients with early Alzheimer’s disease (AD).1
The 76-week study is a randomized, double-blind, placebo-controlled trial conducted by GSK globally across multiple sites. Participants will be randomized to receive either AL101 or placebo intravenously with the therapy being evaluated at two different dosing levels. The primary endpoint is disease progression as measured by the Clinical Dementia Rating Sum of Boxes, which is a validated instrument that tracks the progression of cognitive impairments across multiple categories.
In a press release, Arnon Rosenthal, PhD, chief executive officer of Alector, said: “In partnership with GSK, we are pleased to announce the completion of enrollment ahead of schedule in the PROGRESS-AD Phase II clinical trial of AL101, marking an important milestone in our pursuit of developing first-in-class therapies for Alzheimer’s disease. This achievement brings us one step closer to assessing the potential of AL101 in slowing disease progression and to furthering our understanding of AL101’s effects on individuals living with this devastating condition. We remain committed to advancing our progranulin-elevating candidate and evaluating its impact in the ongoing trial.”
The investigational AL101/GSK4527226 is designed to block and downregulate the sortilin receptor to elevate progranulin (PGRN), which is a protein responsible for regulating lysosomal function, neuronal survival, and inflammation. It is genetically linked to a number neurodegenerative disorders.
In July 2021, Alector and GSK entered into a global collaboration to develop two clinical stage first-in-class monoclonal antibodies for neurodegenerative diseases including AL101/GSK4527226.2
In a press release from the time, Hal Barron, then chief scientific officer and president R&D, GSK, said: “Our focus on human genetics and the science of the immune system gives us unique insights into the potential of targets such as progranulin to help patients with a number of neurodegenerative diseases. Working with Alector’s world class scientists will allow us to investigate the potential of these immuno-neurology therapies to help patients with frontotemporal dementia, a devastating disease without any currently approved treatments, as well as explore the ability to help patients with other neurodegenerative diseases, such as ALS, Parkinson’s, and Alzheimer’s.”
Rosenthal added: “This transformative collaboration brings together Alector’s leading immuno-neurology expertise with GSK’s commitment to immunology and human genetics, proven drug development capabilities and global footprint, to help expand and accelerate the development of our progranulin franchise into large indications, while bolstering the build out of our own late-stage development and commercial capabilities. Importantly, this collaboration is designed to fully support AL001 and AL101’s development and to enable Alector to continue building a fully integrated company as we strive to address the high unmet medical need in patients suffering from neurodegenerative diseases. We are confident that GSK’s extensive experience launching ground-breaking medicines at the intersection of immunology and human genetics, will ensure that AL001 and AL101 are developed to their full potential.”
Alector shared results from the first-in-human Phase I study of AL101 in November 2022. In the trial, AL101 was generally well tolerated and demonstrated elevated PGRN levels in the cerebrospinal fluid. The randomized, double-blind, placebo-controlled study enrolled 88 healthy volunteers.3
References
1. Alector Announces Completion of Enrollment in the PROGRESS-AD Phase 2 Clinical Trial of AL101/GSK4527226 in Individuals with Early Alzheimer’s Disease. Alector. News release. April 17, 2025. Accessed April 18, 2025. https://investors.alector.com/news-releases/news-release-details/alector-announces-completion-enrollment-progress-ad-phase-2
2. Alector and GSK announce global collaboration in immuno-neurology for two clinical stage first-in-class monoclonal antibodies for neurodegenerative diseases. Alector. News release. July 2, 2021. Accessed April 18, 2025. https://investors.alector.com/news-releases/news-release-details/alector-and-gsk-announce-global-collaboration-immuno-neurology
3. Alector Presents Results from First-in-Human Phase 1 Study of AL101 for the Treatment of Neurodegenerative Diseases. Alector. News release. November 29, 2022. Accessed April 18, 2025. https://investors.alector.com/news-releases/news-release-details/alector-presents-results-first-human-phase-1-study-al101
Improving Relationships and Diversifying the Site Selection Process
April 17th 2025In this episode of the Applied Clinical Trials Podcast, Liz Beatty, co-founder and chief strategy officer, Inato, discusses a number of topics around site engagement including community-based sites, the role of technology in improving site/sponsor relationships, how increased operational costs are impacting the industry, and more.
Behind the Buzz: Why Clinical Research Leaders Flock to SCOPE Summit
February 7th 2025In this episode, we meet with Micah Lieberman, Executive Conference Director for SCOPE Summit (Summit for Clinical Ops Executives) at Cambridge Innovation Institute. We will dive deep into the critical role of collaboration within the clinical research ecosystem. How do we bring together diverse stakeholders—sponsors, CROs, clinical trial tech innovators, suppliers, patients, sites, advocacy organizations, investors, and non-profits—to share best practices in trial design, program planning, innovation, and clinical operations? We’ll explore why it’s vital for thought leaders to step beyond their own organizations and learn from others, exchanging ideas that drive advancements in clinical research. Additionally, we’ll discuss the pivotal role of scientific conferences like SCOPE Summit in fostering these essential connections and collaborations, helping shape the future of clinical trials. Join us as we uncover how collective wisdom and cross-industry partnerships are transforming the landscape of clinical research.
FDA-Approved Gene Therapy Beqvez Shows Sustained Efficacy, Safety in Long-Term Hemophilia B Trial
April 17th 2025Beqvez (fidanacogene elaparvovec), an FDA-approved one-time gene therapy for hemophilia B, demonstrated sustained factor IX expression, low bleeding rates, and a favorable safety profile over long-term follow-up.
