PathMaker Neurosystems Announces $2.16 Million Award from U.S. Department of Defense for ALS Clinical Trial
Federal Funding Supports PathMaker’s Continued Development of Company’s Non-Invasive Treatment Platform for Amyotrophic Lateral Sclerosis
Boston, MA – June 5, 2024 – PathMaker Neurosystems Inc. (“PathMaker”), a clinical-stage neuromodulation company developing breakthrough non-invasive systems for the treatment of serious neurological disorders, announced today that it has received a funding award of $2.16 million from the Congressionally Directed Medical Research Program (CDMRP) at the United States 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 award will fund PathMaker’s expanded pilot study, called the CALM study, “Controlling Amyotrophic Lateral Sclerosis Motor Neuron Excitability”, using PathMaker’s MyoRegulator® investigational device to treat people with ALS. The trial is set to begin by late 2024 at two leading Boston-area centers, 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 trial for ALS.
Co-Investigators on the DoD-funded program include Zaghloul Ahmed, Ph.D., PT, Chairman of Department of Physical Therapy/Program in Neuroscience at CUNY/CSI and PathMaker’s Scientific Founder; Leon Morales-Quezada, M.D., Ph.D., MPH, 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.
Nader Yaghoubi, M.D., Ph.D., PathMaker’s Co-Founder and CEO, and Principal Investigator on the program, stated, “We are very pleased to have DoD’s support as we launch our second clinical trial for our non-invasive ALS neuromodulation platform. We’ve had a team of noted and world-class Co-Investigators come together to help design and run this state-of-the-art ALS trial, and we look forward to getting enrollments underway in the coming months to expand our evidence base.”
This work is supported by the Office of the Assistant Secretary of Defense for Health Affairs endorsed by the Department of Defense, through the Amyotrophic Lateral Sclerosis Research Program, in the amount of $2,163,115, under Award No. HT94252410407. Opinions, interpretations, conclusions, and recommendations are those of the author and are not necessarily endorsed by the Department of Defense.
About the FY23 Amyotrophic Lateral Sclerosis Research Program Pilot Clinical Trial Award
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, 820 Chandler Street, Fort Detrick MD 21702-5014 is the awarding and administering acquisition office. The ALSRP was initiated in 2007 to provide support for research of exceptional scientific merit.
About PathMaker Neurosystems Inc.
PathMaker Neurosystems is a clinical-stage neuromodulation company developing breakthrough non-invasive systems for the treatment of people with serious neurological disorders such as amyotrophic lateral sclerosis (ALS) and stroke. From its headquarters in Boston, PathMaker is collaborating with world-class 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 by the US Food and Drug Administration (FDA) as a “FDA Breakthrough Device.” MyoRegulator® and MyoRegulator® ALS are investigational medical devices and are limited by Federal law to investigational use only. For more information, please visit the company website at www.pmneuro.com.
Source: PathMaker Neurosystems Inc.
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