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.
Please contact (855)-437-4823 or email email@example.com 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.
ALS Center at the Swedish Neuroscience Institute
Seattle, Washington 98122
Barrow Neurological Institute
Phoenix, Arizona 85013
Carol and Frank Morsini Center for Advanced Health Care – University of South Florida
Tampa, Florida 33612
Emory University Hospital
Atlanta, Georgia 30322
Forbes Norris MDA/ALS Research Center – California Pacific Medical Center
San Francisco, California 94114
Hennepin County Medical Center
Minneapolis, Minnesota 55415
Johns Hopkins Hospital
Baltimore, Maryland 21287
Massachusetts General Hospital
Boston, Massachusetts 02114
Mount Sinai Beth Israel
New York, New York 10003
Neurology Associates P.C.
Lincoln, Nebraska 68506
Ochsner Neuroscience Institute
New Orleans, Louisiana 70121
Oregon Health & Science University
Portland, Oregon 97239
Temple University Hospital
Philadelphia, Pennsylvania 19140
Texas Neurology, P.A.
Dallas, Texas 75214
The Ohio State University Wexner Medical Center
Columbus, Ohio 43221
The Penn Comprehensive ALS Center
Philadelphia, Pennsylvania 19107
UC Irvine Medical Center
Orange, California 92868
University of Florida Medical Center
Gainesville, Florida 32610
University of Iowa Hospitals and Clinics
Iowa City, Iowa 52242
University of Kentucky Medical Center
Lexington, Kentucky 40536
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts 01655
University of Michigan Medical Center
Ann Arbor, Michigan 48109
University of Texas Health Science Center at San Antonio
San Antonio, Texas 78229
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina 27157
Washington University Medical Center
Saint Louis, Missouri 63110