Clinical Trial: Amylyx Pharmaceuticals is Now Enrolling in Phase II CENTAUR Clinical Trial

Amylyx Pharmaceuticals, championed by The ALS Association, is currently enrolling up to 132 individuals nationwide for a Phase II CENTAUR (Combination of Phenylbutyrate and Tauroursodeoxycholic Acid) clinical trial to assess the efficacy and safety of AMX0035 for the treatment of ALS. The Neurology Clinical Research Institute (NCRI) at Massachusetts General Hospital and the Northeast ALS Consortium (NEALS) will oversee the trial, and 25 NEALS member medical centers across the United States will participate. The ALS Association, along with ALS Finding a Cure® supported this important trial with a $2.96 million grant.

CENTAUR is a 24-week, randomized, double-blind, placebo-controlled Phase II clinical trial. The trial’s primary objectives are to evaluate the safety and tolerability of AMX0035 and assess the drug’s impact on disease progression as measured by the revised Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS-R) over the 24-week study period. The trial will also evaluate the impact of AMX0035 on isometric strength as measured by ATLIS (Acute Test of Limb Isometric Strength), respiratory function and exploratory biomarkers. This is the first multi-center trial to use ATLIS, which was developed by Dr. Patricia Andres of Massachusetts General Hospital. There will also be an open label extension to the trial so that all enrolled patients will have the option of continuing treatment once the 24-week treatment period concludes.

Amylyx CEO and co-founder, Joshua Cohen (LEFT) commented, “We are tremendously grateful for the support we have received from the ALS community.” Justin Klee (RIGHT), President and co-founder added, “The study reflects the outstanding progress the Amylyx team and our collaborators made to build a strong clinical program aimed at ultimately improving the lives of patients with this devastating disease.”

The Amylyx therapeutic candidate, AMX0035, is an oral combination of sodium phenylbutyrate (PB) and tauroursodeoxycholic acid (TUDCA) that works synergistically to reduce neuronal death and inflammation. Both PB and TUDCA have been individually tested in previous ALS clinical trials; both compounds demonstrated safety, tolerability and preliminary signs of efficacy.

More information on the CENTAUR trial can be found at www.clinicaltrials.gov, NCT03127514 or on the NEALS clinical trials site.

Please contact (855)-437-4823 or email alstrials@neals.org if you are interested in participating. Contact information for trial sites will be made available on clinicaltrials.gov.

Read press release here.

Read more about The Association funded clinical trial study here.

Trial sites:

ALS Center at the Swedish Neuroscience Institute
Seattle, Washington 98122
United States

Barrow Neurological Institute
Phoenix, Arizona 85013
United States

Carol and Frank Morsini Center for Advanced Health Care – University of South Florida
Tampa, Florida 33612
United States

Emory University Hospital
Atlanta, Georgia 30322
United States

Forbes Norris MDA/ALS Research Center – California Pacific Medical Center 
San Francisco, California 94114
United States

Hennepin County Medical Center
Minneapolis, Minnesota 55415
United States

Johns Hopkins Hospital
Baltimore, Maryland 21287
United States

Massachusetts General Hospital
Boston, Massachusetts 02114
United States

Mount Sinai Beth Israel
New York, New York 10003
United States

Neurology Associates P.C.
Lincoln, Nebraska 68506
United States

Ochsner Neuroscience Institute 
New Orleans, Louisiana 70121
United States

Oregon Health & Science University
Portland, Oregon 97239
United States

Temple University Hospital 
Philadelphia, Pennsylvania 19140
United States

Texas Neurology, P.A. 
Dallas, Texas 75214
United States

The Ohio State University Wexner Medical Center
Columbus, Ohio 43221
United States

The Penn Comprehensive ALS Center
Philadelphia, Pennsylvania 19107
United States

UC Irvine Medical Center
Orange, California 92868
United States

University of Florida Medical Center
Gainesville, Florida 32610
United States

University of Iowa Hospitals and Clinics
Iowa City, Iowa 52242
United States

University of Kentucky Medical Center 
Lexington, Kentucky 40536
United States

University of Massachusetts Memorial Medical Center
Worcester, Massachusetts 01655
United States

University of Michigan Medical Center 
Ann Arbor, Michigan 48109
United States

University of Texas Health Science Center at San Antonio
San Antonio, Texas 78229
United States

Wake Forest Baptist Medical Center 
Winston-Salem, North Carolina 27157
United States

Washington University Medical Center
Saint Louis, Missouri 63110
United States

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