USA: new law promises $100 million for ALS research

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

Av Lucie van Leeuwen.Publicerad 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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Recruiting
Fas i

PRO-101 trial

Gesponsorde Trial
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Recruiting
Fas 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.
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Recruiting
Fas ii

AP101-02

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.
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Recruiting
Fas iii

ATLAS-studie

Företagsinitierad prövning
Biogen genomför en klinisk studie för att bedöma effektiviteten och säkerheten hos ett prövningsläkemedel för vuxna som inte har några kliniska tecken eller symtom på amyotrofisk lateralskleros (ALS) (som definitivt tyder på att ALS-sjukdomen har debuterat) men som bär på en viss variant av genen superoxiddismutas 1 (SOD1).
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Completed
Fas iii

PHOENIX studie

Företagsinitierad prövning
Amylyx Pharmaceuticals Inc utför en fas 3-studie för att fastställa säkerheten och effektiviteten av deras förening 'AMX0035' för behandling av SLA.
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Completed
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ADORE Studie

Företagsinitierad prövning
Ferrer håller på att utföra en fas 3-studie för att bedöma säkerheten och den potentiella effektiviteten av ett prövningsläkemedel för personer med Amyotrofisk lateralskleros (SLA).
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MAGNET-prövning

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MAGNET-prövningen är en innovativ klinisk plattformsprövning som undersöker flera läkemedel mot ALS samtidigt.
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