Our mission is to accelerate therapeutic and biomarker development for ALS.
The Accelerating Medicines Partnership® in Amyotrophic Lateral Sclerosis (AMP® ALS) Program brings together the resources and expertise of the NIH and other stakeholders from academia, life science companies, foundations, patient-focused groups, and research nonprofits to tackle the tremendous challenges of diagnosing, understanding, and treating ALS, a progressive and ultimately fatal neurological disease.
AMP ALS will build the largest data source for ALS research and expedite the identification of biomarkers and clinical outcome assessments that would allow earlier diagnosis and accelerated drug development.
AMP ALS is a component of the public-private partnership called for in H.R.3537-Accelerating Access to Critical Therapies for ALS Act (ACT for ALS), signed into law by President Biden in December 2021. Multiple clinical sites across the country have joined the NIH-funded Access for All in ALS (ALL ALS) Consortium, which will recruit people with ALS and those at risk for the disease to collect clinical data and biosamples.
A Relentless Disease
ALS is characterized by the degeneration of both upper and lower motor neurons, leading to progressive muscle weakness and paralysis. In approximately 30% of cases, non-motor neurons in the frontal and temporal regions of the brain are also affected, causing impairments in various cognitive domains. The disease is uniformly fatal. The average survival is only two to five years after diagnosis, although some individuals succumb even faster, while others survive for more than a decade.
To date, treatment options for ALS remain severely limited, have modest benefits, and do not halt or reverse the progression of ALS. Thus, there is an urgent unmet need to develop more effective treatments for ALS.
A Collaborative Effort
The AMP ALS research team will collect and centralize both current and future ALS datasets in a cloud-based, openly accessible knowledge portal. Access to this comprehensive resource—which will include data from digital health technology—will enable researchers to focus on identifying and validating biomarkers and therapeutic targets specific to ALS. Researchers will also address the need for new or modified clinical outcome assessments, including patient-reported outcomes.
Biomarkers are crucial for earlier diagnosis of ALS, potentially before symptoms appear, allowing for possible interventions and improved quality of life. In addition, validated biomarkers will help monitor disease progression and patients’ response to treatment, improve clinical trial design, and potentially lead to more effective, personalized drug treatments.
Partners
PUBLIC SECTOR PARTNERS
National Institute of Neurological Disorders and Stroke, NIH
United States Food and Drug Administration
EXECUTION PHASE: PRIVATE-SECTOR PARTNERS
DESIGN PHASE: PRIVATE SECTOR PARTNERS
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