Alzheimer’s Drug: First Human Clinical Trial

brainhealth3

Cleveland Clinic spinoff company to start clinical trials for Alzheimer’s disease

Cleveland Clinic spinoff company NeuroTherapia Inc. will start clinical trials of a new drug targeting inflammation of the brain that’s found in Alzheimer’s and other neurological diseases, according to a news release.

The U.S. Food and Drug Administration gave the company the go-ahead to begin its first in-human studies of the drug, NTRX-07, in an ascending dose study schedule to begin midsummer.

NeuroTherapia plans to follow this study, which will be in healthy volunteers, with another study in patients with Alzheimer’s disease to explore the safety of repeated dosing of NTRX-07 and to look for changes in inflammation, according to the release.

“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” said Dr. Joseph Foss, the company’s clinical adviser, in a prepared statement. “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.”

 

Northeast Ohio has seen significant momentum in Alzheimer’s disease work in recent months, with several multimillion-dollar grants supporting such research awarded to local institutions and researchers — part of a national push to find prevention and treatment options for Alzheimer’s disease and other dementias.

“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,” said Dr. Mohamed Naguib, scientific adviser and co-discoverer of NTRX-07, in a prepared statement. “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.”

NTRX-07, a small orally available molecule, targets receptors that increase in diseases, including Alzheimer’s disease, amyotrophic lateral sclerosis (ALS), multiple sclerosis (MS) and chronic pain syndromes, according to the release.

brain

In various animal models of Alzheimer’s disease, NTRX-07 restored normal function of the microglia, which are key immune cells in the brain.

This 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,” according to the release.

brainhealth11

Naguib and Foss are entitled to a portion of any revenues Cleveland Clinic receives related to the technology, according to the release. Specific terms of the revenue share were not disclosed.

Comments

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out /  Change )

Google photo

You are commenting using your Google account. Log Out /  Change )

Twitter picture

You are commenting using your Twitter account. Log Out /  Change )

Facebook photo

You are commenting using your Facebook account. Log Out /  Change )

Connecting to %s