NeuroTherapia, Inc., a Cleveland Clinic spin-off company, has started its first-in-human Phase I clinical trial of NTRX-07, a new drug targeting the inflammation in the brain that is found in Alzheimer’s disease (AD) and other neurological diseases. The U.S. Food and Drug Administration (FDA) accepted their Investigational New Drug (IND) filing earlier this year, which allows NeuroTherapia to begin its first-in-human studies of NTRX-07 in an ascending dose study in normal, healthy volunteers. Based upon the data from this study, the company plans to follow with a study in patients with Alzheimer’s disease and other diseases such as amyotrophic lateral sclerosis (ALS) to explore the safety of repeated dosing of NTRX-07 and to look for changes in inflammation through studying biomarkers.
“We are excited to initiate this Phase I study. We have strong evidence in preclinical models of Alzheimer’s disease and in chronic pain that NTRX-07 is a potential new approach to treating these challenging conditions. ” commented Dr. Joseph Foss, the company’s co-founder and medical director. “This study will allow us to identify the safe dose, potential side effects and levels of the drug in the body. These results will then be used in the design of a Phase Ib study in patients to see how NTRX-07 is tolerated and to potentially demonstrate some early evidence of benefits.”
Dr. Mohamed Naguib, the scientific advisor and the co-discoverer of NTRX-07, notes, “NTRX-07 is the first drug entering clinical trials that addresses the changes in the immune system of the brain brought about by inflammation. Inflammation plays a key role in neurodegenerative diseases, including AD, by damaging brain cells involved in memory and other functions. NTRX-07 has been shown to control inflammation in the brain in several different models of this disease.”
This study is being supported by a generous grant from the Part the Cloud program of the Alzheimer’s Association.
Drs. Naguib and Foss are entitled to a portion of any revenues Cleveland Clinic receives related to the technology.
NTRX-07 is a small orally available molecule that targets receptors that increase in diseases including Alzheimer’s disease, amyotrophic lateral sclerosis (ALS), multiple sclerosis (MS), and chronic pain syndromes. In various animal models of AD, NTRX-07 restored normal function of the microglia (key immune cells in the brain) which in turn decreased microglial-induced inflammation, reduced levels of the Alzheimer’s associated A-beta peptide in the brain, and substantially improved neuronal synaptic plasticity, learning, and memory.
About NeuroTherapia, Inc.
NeuroTherapia, Inc. is a Cleveland-based biotech company, spun out of Cleveland Clinic in 2015, developing a novel small molecule, NTRX-07, for the treatment of Alzheimer’s disease. The Company has received financing from the Alzheimer’s Drug Discovery Foundation, Dolby Family Ventures and Cleveland Clinic, as well as grsnt funding from the Alzheimer’s Association. NTRX-07 acts by reducing neural inflammation and promoting neuronal survival.