CENTAUR Trial

The CENTAUR trial, a phase 2 clinical trial of AMX0035 for ALS, enrolled its first patient in July of 2017 and reached its primary clinical endpoint in late 2019, when patients were given the option of moving to an open-label extension to study long-term use of the drug.

News about the study includes:

• Amylyx Submits New Drug Application for AMX0035
  11/2/2021: An update from Amylyx about the application process
• Amylyx Pharmaceuticals to Submit New Drug Application for AMX0035
  9/15/2021: Amylyx announces plans to submit AMX0035 for FDA approval
• An Update on the CENTAUR Trial
  5/17/2021: Dr. Sabrina Paganoni and Dr. Merit Cudkowicz from the Sean M. Healey & AMG Center for ALS at Mass General Hospital discuss the trial in a webinar hosted by NEALS
• 2021 Clinical Research Forum: The CENTAUR Trial for ALS
  3/24/2021: Sabrina Paganoni, MD, PhD explains the exciting results from the CENTAUR trial for ALS, a finalist in the Top 10 Clinical Research Awards from the Clinical Research Forum
• AMX0035 Lowers Risk for Adverse Events, Death in Patients with ALS
  3/22/2021: Healio covers ongoing results from the CENTAUR trial and its extension study, which are providing a growing pool of evidence that the experimental ALS treatment may be safe and effective. Dr. Paganoni's presentation of the data at the annual MDA conference was also covered in ALS News Today
• Amylyx Planning to Ask Health Canada to Approve AMX0035 to Treat ALS
  3/11/2021: Sabrina Paganoni, MD, PhD, who led a clinical trial of the experimental ALS drug AMX0035, is quoted in this article about possible approval by Canadian regulators
• A New ALS Drug is Extending Patients' Lives by Months.
  3/2/2021: USA Today covers efforts to fast-track approval for the experimental ALS drug AMX0035 and ongoing research at the Healey Center for ALS

Initial Trial Results Publication

On September 2, 2020 the New England Journal of Medicine published the results of the unique trial, showing significant slowing of ALS disease progression. This is the first time an ALS therapy has shown effectiveness in accomplishing more than a reduction of symptoms, opening the door to preventing nerve cell death and offering hope to individuals with ALS and their families.

Hear from the Director of the Sean M. Healey and AMG Center for ALS Merit Cudkowicz, MD, MSc and CENTAUR Trial Lead Investigator Sabrina Paganoni, MD, PhD, as they share details of the trial results and next steps in the treatment process.

Read full announcement

Webinar

Mass General researchers shared information about the trial in a webinar hosted the Northeast ALS Consortium (NEALS) on Sept. 4, 2020. A recording is available at NEALS.org.