Research & Technology
Spectrum Health to Participate in the HEALEY ALS Platform Trial, the First of Its Kind for ALS
One of 54 sites where multiple treatments will be evaluated simultaneously
GRAND RAPIDS, Mich., Oct. 27, 2020 – Spectrum Health is one of 54 sites of the Northeast ALS Consortium (NEALS), which has received approval from the U.S. Food and Drug Administration (FDA) to proceed with administering three proposed drug regimens in the HEALEY ALS Platform Trial – the first trial of its kind for amyotrophic lateral sclerosis (ALS).
The Sean M. Healey & AMG Center for ALS at Massachusetts General Hospital is leading the trial in partnership with TackleALS.
A “platform trial” is a clinical trial in which multiple treatments are evaluated simultaneously. This model, already used in the cancer field, is expected to accelerate development of treatments for people with ALS (also known as Lou Gehrig’s disease) by allowing investigators to test more drugs, increase patient access to trials, and reduce the cost by quickly and efficiently evaluating the effectiveness of multiple therapies.
“We are thrilled to be one of three sites in the state of Michigan involved in the HEALEY ALS Platform Trial,” said Paul Twydell, DO, Spectrum Health’s director of neuromuscular medicine. “It is our hope that the trial will bring us closer to the development of advanced treatments for ALS.”
The ALS Association named Spectrum Health a Certified Treatment Center of Excellence Program in 2018, determining the Spectrum Health ALS Multidisciplinary Clinic meets the highest national standards of care in the management of the disease.
ALS is the most prevalent adult-onset progressive motor neuron disease, affecting approximately 30,000 people in the U.S. and an estimated 500,000 people worldwide. ALS causes the progressive degeneration of motor neurons, resulting in progressive muscle weakness and atrophy. There are currently three FDA therapies approved specifically for treating ALS—riluzole, Nuedexta and edaravone.
The three experimental treatments include: Zilucoplan, a small macrocyclic peptide inhibitor of complement component 5 [C5], Verdiperstat, an oral myeloperoxidase inhibitor, and CNM-Au8 nanocrystalline gold, an intracellular nanocatalyst to support cellular bioenergetics.
The 54 NEALS trial-ready sites across the US must undergo several steps before individuals can officially enroll in the study. These include obtaining approval from the central Institutional Review Board (IRB), training of the NEALS sites on the study protocol, contracting with the different vendors key to drug distribution, and safety monitoring and biomarker development.
Dr. Twydell said he expects the trial to open at Spectrum Health in the last quarter of 2020.
The HEALEY ALS Platform trial is a perpetual study that will continue to add interventions until cures are found for ALS.
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