USA: new law promises $100 million for ALS research

A new law has been passed in the United States to give…

Words Lucie van Leeuwen.Published January 13, 2022
USA: new law promises $100 million for ALS research

A new law has been passed in the United States to give more people with ALS access to experimental treatments. The government is also pledging $100 million a year for research into new treatments over the next five years.

Only a small proportion of people with ALS participate in clinical trials. This happens for various reasons. For example, many studies still use restrictive entry criteria, denying many people with ALS access to clinical trials. For other people, participation might  be physically too challenging. One of TRICALS’ goals is therefore to make trials accessible for everyone living with ALS. The new American law, called Accelerating Access to Clinical Therapies (ACT) for ALS, will make money available to give more people access to experimental treatments.

The passing of the ACT for ALS bill would not have been possible without the commitment and determination of thousands of ALS advocates. They have worked together and campaigned tirelessly to get the ACT for ALS on the political agenda. With success: on December 23rd, President Biden signed the bill into law.

ACT for ALS

ACT for ALS contains four components:

  • Grants for research on therapies for ALS
    Funding will be available so that people with ALS, who for reasons cannot participate in the clinical trial, may still get access to investigational ALS treatments. This applies to drugs being tested in phase 3 clinical trials.
  • Public-Private Research Partnerships
    The aim is to encourage collaborations between the government and private companies, universities and other research institutes. These collaborations should accelerate research into ALS and other neurodegenerative diseases.
  • FDA Grant Program
    An FDA (U.S. Food and Drug Administration) funding program for research into ALS and related conditions. The funding is mainly intended for projects aiming to learn how these conditions progress, discover new drug targets and improving clinical trial design.
  • Publication of action plan
    The FDA must publish an action plan within six months, outlining how they will accelerate drug development and increase access to investigational therapies.

More information about the ACT for ALS law can be found on the website of I AM ALS.


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Current Clinical Trials
Recruiting
Phase i

VRG50635 study

Industry trial
Verge Genomics is conducting a phase 1b trial to evaluate the safety, tolerability, and potential efficacy of VRG50635 for people with Amyotrophic Lateral Sclerosis (ALS).
Read more
Active
Phase ii

DAZALS trial

Industry trial
In this study, an investigational oral drug named dazucorilant (also called CORT113176) is being studied in people living with ALS (also known as MND) to understand its safety (side effects) and to determine if dazucorilant can slow down the worsening of the disease. The effects of dazucorilant will be compared to the effects of a placebo. This study is sponsored by Corcept Therapeutics.
Read more
Active
Phase ii

CARDINALS

Industry trial
The CARDINALS clinical research study is evaluating a study drug (Utreloxastat) to see if it can help slow ALS symptoms. Researchers will also test the safety and tolerability of the study drug and how the body responds to it. The study drug is a liquid that is swallowed 2 times a day.
Read more
Recruiting
Phase ii

AP101-02

Industry trial
In this study we investigate the safety, tolerability, pharmacodynamics markers and pharmacokinetics (how a drug is absorbed and excreted) of AP-101 in patients with familial and sporadic amyotrophic lateral sclerosis (ALS). Currently, we are only looking for patients with familial ALS (caused by a SOD1 gene mutation) to participate in the study. This study is sponsored by AL-S Pharma.
Read more
Recruiting
Phase iii

ATLAS trial

Industry trial
Biogen is conducting a clinical trial to evaluate the efficacy and safety and of an investigational drug for adults who do not have any clinical signs or symptoms of Amyotrophic Lateral Sclerosis (ALS) (that definitely indicate the onset of ALS) but do carry a certain superoxide dismutase 1 (SOD1) gene variant.
Read more
Recruiting
Phase iii

FUSION trial

Industry trial
In this study we investigate the safety and efficacy of the study drug ‘ION363’ for the treatment of ALS caused by mutations in the FUS gene. About 1% to 5% of ALS cases are caused by FUS mutations.
Read more
Completed
Phase iii

PHOENIX trial

Industry trial
Amylyx Pharmaceuticals Inc is conducting a phase 3 trial to determine the safety and efficacy of their compound 'AMX0035' for the treatment of ALS.
Read more
Completed
Phase iii

ADORE trial

Industry trial
Ferrer is conducting a phase 3 trial to evaluate the safety and potential efficacy of an investigational drug for people with Amyotrophic Lateral Sclerosis (ALS).
Read more
Completed
Phase iii

TUDCA-ALS

Investigator initiated trial
This trial will evaluate the efficacy of tauroursodeoxycholic acid (TUDCA) as add-on treatment for people with ALS.
Read more

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