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Multi-path DCS as a novel non-invasive treatment for amyotrophic lateral sclerosis

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R41NS125872-01
Agency Tracking Number: R41NS125872
Amount: $371,628.00
Phase: Phase I
Program: STTR
Solicitation Topic Code: 109
Solicitation Number: PA20-265
Timeline
Solicitation Year: 2020
Award Year: 2021
Award Start Date (Proposal Award Date): 2021-09-23
Award End Date (Contract End Date): 2022-08-31
Small Business Information
ONE INTERNATIONAL PLACE STE 1400
Boston, MA 02110-2619
United States
DUNS: 079669858
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 ZAGHLOUL AHMED
 (718) 982-2980
 zaghloul.ahmed@csi.cuny.edu
Business Contact
 NADER YAGHOUBI
Phone: (617) 535-7696
Email: nyaghoubi@pmneuro.com
Research Institution
 COLLEGE OF STATEN ISLAND
 
2800 VICTORY BOULEVARD
NEW YORK, NY 10314-6609
United States

 Nonprofit College or University
Abstract

PROJECT SUMMARY / ABSTRACT
Amyotrophic lateral sclerosis (ALS) is a progressive neurodegenerative disease that affects motor neurons in
the spinal cord and brain. ALS causes muscle weakness and paralysis and eventually death. According to the
ALS Association, every 90 minutes there is a new diagnosis of ALS, as well as an associated death. Nearly
5,000 people are diagnosed with ALS each year and at least 16,000 are living with the disease at any given time
in USA alone. There are 3 FDA-approved drugs for ALS, however, the effectiveness of these drugs is limited. In
this Phase 1 STTR project, we propose translational studies to evaluate the effects of a recently developed
neuronal hyperexcitability suppression technique in ALS models. If successful, the implications of the current
project are far-reaching changes in clinical practice for treating ALS using non-invasive hyperexcitability
suppression. PathMaker Neurosystems Inc. is a clinical-stage neuromodulation company developing first-in-
class devices for the treatment of serious neurological disorders based upon our pioneering multi-path DCS
technology, which enables the non-invasive modulation of spinal circuits and motor neuron activity. Our objective
for this Phase 1 STTR project is to conduct key translational studies that will be essential for advancing this
hyperexcitability suppression technology towards human clinical trials as a safe and efficacious new treatment
for ALS. The project consists of 3 Specific Aims: In Specific Aim 1, we will develop and deliver research-use
multi-path DCS devices facilitating concurrent animal stimulations. In Specific Aim 2, we will expand on initial
transgenic ALS mouse studies to further assess the effects of multi-path DCS on survival, motor function and
excitability. In Specific Aim 3, we will conduct motor neuron counts to assess the effects of multi-path DCS on
motor neuron survival. These Specific Aims will help generate a package of pre-clinical data that will provide a
basis to move the technology into a human clinical feasibility study. As our company works to translate the
groundbreaking academic studies that have identified a novel approach to the treatment of ALS based on
neuronal hyperexcitability suppression, Phase 1 STTR support will advance this revolutionary treatment option
to the brink of human clinical trials, and will pave the way for application of this technology to potentially other
motor neuron diseases.PROJECT NARRATIVE
Amyotrophic lateral sclerosis (ALS) is a rapidly fatal neurodegenerative disease that affects motor neurons in
the spinal cord and brain, leading to muscle weakness, paralysis and eventual death. There are only 3 FDA-
approved drugs for ALS, however, none of these drugs lead to increased patient survival. Our company and its
scientific advisors have developed a novel approach to non-invasively modulating spinal pathways involved in
ALS using neuronal hyperexcitability suppression. PathMaker Neurosystems Inc. is a clinical-stage
neuromodulation company developing first-in-class treatments for serious neurological disorders based on our
pioneering hyperexcitability suppression technology, which enables the non-invasive modulation of spinal
pathways and motor neuron activity. This Phase 1 STTR project will enable crucial studies that will give important
efficacy information, as well as enable development of a research-use stimulation device that will facilitate and
increase the throughput of ALS mouse studies.

* Information listed above is at the time of submission. *

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