CLEVELAND, OH – NeuroTherapia, Inc., a Cleveland Clinic spin-off company, will be starting clinical trials of NTRX-07, a new drug targeting 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 the IND filing which allows NeuroTherapia to begin its first-in-human studies of NTRX-07 in an ascending dose study in normal healthy volunteers, which is scheduled to begin in mid-summer. Based upon the data from this study, the company plans to follow with a study in patients with Alzheimer’s disease to explore the safety of repeated dosing of NTRX-07 and to look for changes in inflammation by studying biomarkers.
“The ability to begin studies in human subjects is a critical milestone for NeuroTherapia in its efforts to develop new treatments for patients with neurologic diseases for which there are currently no good therapies” commented Dr. Joseph Foss, the company’s clinical advisor. “By identifying the safe dose in this study, we will be able to design a Phase Ib study in Alzheimer’s patients to see how NTRX-07 is tolerated and to potentially demonstrate some early evidence of benefits.”
Dr. Mohamed Naguib, scientific advisor, and the co-discoverer of NTRX-07, also was excited about the ability to start first in human studies, “We have known for a long time that the immune system of the brain and inflammation play a key role in neurodegenerative diseases, including AD. NTRX-07 is the first drug entering clinical trials which addresses these changes. To be able to potentially help patients with this devastating disease makes all our efforts worthwhile.”
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 Ab peptide in the brain, and substantially improved neuronal synaptic plasticity, learning, and memory.
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 non-dilutive funding from the Alzheimer’s Association. NTRX-07 acts by reducing neural inflammation and promoting neuronal survival through the specific activation of cannabinoid type 2 (CB2) receptors expressed on activated microglia. NTRX-07 has also been demonstrated to be effective in various animal models of neuropathic pain.