FDA Funding Announcement Delivers on ACT for ALS Promise

Washington, D.C. (October 18, 2022) – The U.S. Food and Drug Administration awarded $3.7 million to three ALS research projects as part of the implementation of the Accelerating Access to Critical Therapies for Amyotrophic Lateral Sclerosis Act (ACT for ALS)

The ALS funding is part of FDA’s 19 grant awards and two contracts announced on October 17 totaling $38 million to support rare disease research over the next four years. 

“We fought tirelessly to secure passage and funding for the ACT for ALS to accelerate efforts to develop new, effective treatments and cures as well as reduce the harms and burdens of ALS. This new funding helps to move us closer to our organizational goal of making ALS a livable disease, and closer to finding ways to cure for ALS,” said Calaneet Balas, President and CEO of The ALS Association.  

“However, the FDA’s funding falls far short of the unmet need for ALS research, expanded access and services to people with ALS. We strongly encourage the FDA, NIH, DOD, and other federal agencies to provide more funding and flexibility to speed treatments and cures for ALS,” she added.  

The FDA awarded $1.6 million to support a natural history study being led by Dr. David Walk out of the University of Minnesota, $1.8 million to RTI International to investigate the potential for at-home use of the ALS Functional Ratings Scale, and $330,000 to RTI International to document patient preferences related to use of brain-computer interfaces.  

In addition to these three new research projects made possible by the ACT for ALS, which was signed into law in December 2021, NIH recently awarded $18 million to an expanded access program for the investigational drug candidate Trehalose. This new program, operated by   Massachusetts General Hospital, provides access to Trehalose for people living with ALS who are not eligible for the ongoing Trehalose clinical trial that is part of the HEALEY ALS Platform Trial.  

The ALS Association will continue to urge Congress to dramatically increase appropriations for ALS research, expanded access and services to people with ALS. 

About ALS 

Amyotrophic lateral sclerosis (ALS) is a progressive neurodegenerative disease that affects nerve cells in the brain and spinal cord. Over the course of the disease, people lose the ability to move, to speak, and eventually, to breathe. On average, it takes about a year before a final ALS diagnosis is made. The disease is always fatal, usually within five years of diagnosis. There is no cure.  

About The ALS Association  

The ALS Association is the largest philanthropic funder of ALS research in the world. The Association funds global research collaborations, assists people with ALS and their families through its nationwide network of care and certified clinical care centers, and advocates for better public policies for people with ALS. The ALS Association is working to make ALS a livable disease while urgently searching for new treatments and a cure. For more information about The ALS Association, visit our website at www.als.org 

For more information, contact:
Brian Frederick
The ALS Association
(202) 464-8612