GSK, Alector to Develop Antibodies for Neurodegenerative Diseases

GSK and Alector recently entered into a strategic global collaboration to develop and commercialize two clinical-stage, potential first-in-class monoclonal antibodies for neurodegenerative diseases.

The antibodies, AL001 and AL101, are designed to elevate progranulin levels. Progranulin is a key regulator of immune activity in the brain with genetic links to various neurodegenerative disorders. 

“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,” Hal Barron, chief scientific officer and president of research and development at GSK said in the announcement. 

“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,” Barron continued. 

The collaboration will combine Alector’s leading immunology-neurology expertise with GSK’s research and development focus on the science of the immune system, human genetics, late-stage development, and global footprint. 

Trial enrollment is underway for a pivotal Phase 3 clinical trial for AL001 in individuals at risk for or with frontotemporal dementia due to a progranulin gene mutation (FTD-GRN). FTD-GRN is a rapidly progressing and severe form of dementia found primarily in individuals under 65 years of age, a GSK spokesperson explained. 

There are currently no approved treatments for frontotemporal dementia.  

AL001 is also in a Phase 2 study in symptomatic FTD patients with a mutation in the C9orf72 gene and will enter Phase 2 development for ALS in the second half of 2021. 

Additionally, the antibody is in a Phase 1a clinical trial designed to treat patients suffering from more prevalent neurodegenerative diseases, including Parkinson’s disease and Alzheimer’s disease.

Under the terms of the agreement, GSK and Alector will share development responsibilities for all late-stage clinical studies for AL001 and AL101 and be jointly responsible for commercialization in the US. 

Alector will receive $700 million in upfront payments and will be eligible to receive up to an additional $1.5 billion in clinical development, regulatory, and commercial launch-related milestone payments.

Additionally, the company will lead the global clinical development of AL001 and AL101 through Phase 2 proof-of-concept. 

“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,” said Arnon Rosenthal, PhD, chief executive officer of Alector.