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.

 

Goals
  • Guided by input from people with lived experience of ALS and the ALS advocacy community, AMP ALS aims to expedite the development of effective new treatments for people living with ALS, or at risk for developing ALS. The goals are to:

     

     

  • 1) Establish a central ALS Knowledge Platform for data sharing and analysis through a cloud-based infrastructure

  • 2) Develop validated biomarkers for early diagnosis and treatment assessment

  • 3) Improve clinical outcome assessments

  • 4) Discover new therapeutic targets and risk factors

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
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DESIGN PHASE: PRIVATE SECTOR PARTNERS
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“It will take all of us working together to make ALS a livable disease and ultimately find a cure. That is why we are pleased to join with other non-profits, as well as public and private organizations, to support AMP ALS. By building on our collective expertise and insight, this partnership will continue to advance the discovery and development of new treatments and biomarkers, accelerating our fight against this devastating disease.”

-Kuldip Dave, PhD Senior Vice President, Research of ALS Association
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“Over the past decade, Biogen has been committed to understanding and addressing the underlying pathophysiology of ALS. We are honored to join the Foundation for the National Institutes of Health and other partners to accelerate these efforts. As co-chair of AMP ALS, I have seen firsthand the value of the collective expertise and shared determination of all involved in this initiative. While we have a number of rich datasets that have been generated over the years, they are decentralized and, in some cases, incomplete. Through the work of AMP ALS, I am confident we will identify new targets and tools to support diagnosis, prognostication, and assessment of treatment response more efficiently – expediting ALS drug development as a whole.”

-Stephanie Fradette, PharmD Head of Neuromuscular Development Unit of Biogen
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