DoD Provides Funding for PathMaker Neurosystems’ ALS Study

PathMaker Neurosystems Inc. (PathMaker) has received $2.16 million from the Congressionally Directed Medical Research Program (CDMRP) at the U.S. Department of Defense’s (DOD) U.S. Army Medical Research and Development Command (USAMRDC), as part of its FY23 Amyotrophic Lateral Sclerosis Research Program (ALSRP) Pilot Clinical Trial Award.

The funding will finance PathMaker’s expanded pilot study (CALM—Controlling Amyotrophic Lateral Sclerosis Motor Neuron Excitability) using the company’s MyoRegulator investigational device to treat ALS patients. The trial is set to begin late this year at two Boston-area facilities: Spaulding Rehabilitation Hospital (SRH) and Beth Israel Deaconess Medical Center (BIDMC).
 
PathMaker’s approach is based on the company’s proprietary platform for motor neuron hyperexcitability suppression, which provides simultaneous multi-site direct current stimulation to modulate mechanisms and circuits associated with ALS motor neuron hyperexcitability. The MyoRegulator device has already been investigated in two completed clinical trials for post-stroke spasticity and one first-in-human ALS trial.
 
Co-investigators on the DoD-funded program include Zaghloul Ahmed, Ph.D., chairman of Department of Physical Therapy/Program in Neuroscience at CUNY/CSI and PathMaker’s scientific founder; Leon Morales-Quezada, M.D., Ph.D., director of the Integrative Rehabilitation Lab at Spaulding Rehabilitation Hospital and assistant professor of Physical Medicine and Rehabilitation; Sabrina Paganoni, M.D., Ph.D., associate professor of Physical Medicine and Rehabilitation at Spaulding Rehabilitation Hospital and faculty at the Healey & AMG Center for ALS at Massachusetts General Hospital; Seward Rutkove, M.D., chair, Department of Neurology at Beth Israel Deaconess Medical Center and Nancy Lurie Marks Professor of Neurology at Harvard Medical School; and Courtney McIlduff, M.D., MMSc, assistant professor of Neurology at Harvard Medical School and director of the Multi-Disciplinary ALS Clinic at Beth Israel Deaconess Medical Center.
 
“We are very pleased to have DoD’s support as we launch our second clinical trial for our non-invasive ALS neuromodulation platform,” PathMaker Co-Founder/CEO and Principal Investigator Nader Yaghoubi, M.D., Ph.D., said. “We’ve had a team of noted co-investigators come together to help design and run this ALS trial, and we look forward to getting enrollments underway in the coming months to expand our evidence base.”
 
The Fiscal Year 2023 (FY23) Amyotrophic Lateral Sclerosis Research Program (ALSRP) supports the rapid implementation of exploratory clinical trials of novel therapeutics or devices with the potential to demonstrate feasibility, inform the design of more advanced trials, and have a significant impact on the treatment or management of Amyotrophic Lateral Sclerosis (ALS). The U.S. Army Medical Research Acquisition Activity is the awarding and administering acquisition office. The ALSRP was initiated in 2007 to provide support for research of exceptional scientific merit.
 
PathMaker Neurosystems is a clinical-stage neuromodulation company developing non-invasive systems for treating serious neurological disorders such as amyotrophic lateral sclerosis (ALS) and stroke. From its headquarters in Boston, PathMaker is collaborating with institutions to develop and bring to market first-in-class products for treating ALS and other neurological disorders with high unmet medical need. More than 30,000 people in the U.S. suffer from ALS, with an additional 6,000 new ALS diagnoses each year in the U.S.
 
The MyoRegulator platform is based on PathMaker’s proprietary technology for motor neuron hyperexcitability suppression. MyoRegulator has been designated a Breakthrough Device by the U.S. Food and Drug Administration.