Trial News & Events

July 12, 2022

"Investigational drug ABBV-CLS-7262 initiates design phase for entry into the HEALEY ALS Platform Trial," published by the Sean M. Healey & AMG Center for ALS

The HEALEY ALS Platform Trial led by the Sean M. Healey & AMG Center for ALS at Massachusetts General Hospital in collaboration with the Northeast ALS Consortium (NEALS) is a trial in which multiple investigational products are tested and evaluated simultaneously to accelerate the development of potential new therapies for people with ALS.

June 13, 2022

"Amylyx Pharmaceuticals Announces Health Canada Approval of ALBRIOZA™ for the Treatment of ALS," published by Amylyx Pharmaceuticals

Albrioza (formerly AMX0035) was approved by Health Canada for ALS this week. NEALS sites and members were leaders of the CENTAUR trial of Albrioza.

June 3, 2022

"New 12-Month Tofersen Data Presented at ENCALS Meeting Show Clinically Meaningful Benefit in People With SOD1-ALS," published by Biogen

12-month data show that earlier initiation of tofersen slowed decline across measures of clinical and respiratory function, strength, and quality of life

June 3, 2022

"Amylyx Pharmaceuticals Receives Notification of PDUFA Date Extension for AMX0035 for the Treatment of ALS," published by Amylyx Pharmaceuticals

New PDUFA goal date scheduled for September 29, 2022 to allow time to review additional data

May 12, 2022

"Mitsubishi Tanabe Pharma America Announces FDA Approval of RADICAVA ORS® (edaravone) for the Treatment of ALS," published by Mitsubishi Tanabe Pharma America

Mitsubishi Tanabe Pharma America, Inc. (MTPA) today announced the U.S. Food and Drug Administration (FDA) has approved RADICAVA ORS^® (edaravone), the oral form of edaravone, for the treatment of amyotrophic lateral sclerosis (ALS), a neurodegenerative disease that currently has no cure and can progress rapidly.

April 27, 2022

"Coya Therapeutics Announces Annals of Neurology Publication Featuring Biomarker Data in ALS Patients Treated with Tregs Cell Therapy," published by Coya Therapeutics

Coya Therapeutics, Inc. (“Coya), a privately held clinical-stage biotechnology company developing first-in-class approaches utilizing autologous regulatory T cells (Treg) and Treg-derived exosome therapeutics for neurodegenerative and autoimmune diseases, today announced the publication of results from a Phase 1 trial entitled “Tregs Attenuate Peripheral Oxidative Stress and Acute Phase Proteins in ALS.”

February 28, 2022

"The HEALEY ALS Platform Trial announces first participants enrolled for investigational product SLS-005 (Trehalose)," published by the Sean M. Healey & AMG Center for ALS

The HEALEY ALS Platform trial led by the Sean M. Healey & AMG Center for ALS at Massachusetts General Hospital in collaboration with NEALS has successfully enrolled its first participants for the investigational product SLS-005 (trehalose injection, 90.5 mg/mL for intravenous infusion).

February 3, 2022

Longitudinal Assessment of the Gut Microbiome in People with ALS

The Neurological Clinical Research Institute at Massachusetts General Hospital is seeking individuals to participate in a Longitudinal Assessment of the Gut Microbiome in People with ALS research study currently enrolling under the direction of Dr. James Berry.

January 26, 2022

Pathogenesis in C9Orf72-Related ALS (Picals)

The Emory ALS Center is looking for adults who are 18 years and older who are at risk for getting diagnosed with C9 ALS in the future.

January 13, 2022

"AI Therapeutics Announces Initiation of a Phase II Clinical Trial of AIT-101 for Treatment of ALS," published by AI Therapeutics

AI Therapeutics, Inc., a clinical-stage biopharmaceutical company developing novel therapeutics for rare diseases, announced today the initiation of a Phase II study for a promising new approach to treat amyotrophic lateral sclerosis (ALS).