CLEVELAND, Dec. 1, 2020 /PRNewswire/ -- NeuroTherapia, Inc., a clinical-stage company focused on developing therapies for neurodegenerative diseases, announced today the completion of its first-in-human study of NTRX-07. This study was a single ascending dose clinical trial carried out in healthy volunteers.
"The lack of dose-limiting toxicity gives us great confidence that this product will be safe for use in patients following longer-term administration," said Joseph Foss, M.D., the Company's Chief Medical Officer. "We were also enthusiastic about the blood levels of NTRX-07 achieved following dosing."
Levels of NTRX-07 measured in the blood were 2-4 fold higher than those predicted from preclinical studies. Side effects were limited to lightheadedness and flushing in subjects in the two highest dosed cohorts. The side effects are likely evidence that that the drug is entering the central nervous system. The study was supported by an Alzheimer's Association Part the Cloud grant and was initially reported at the Alzheimer's Association International Conference in July 2020.
"The completion of this study is an important first step in the development of NTRX-07," said Tony Giordano, Ph.D., the Company's President and CEO. "We anticipate initiating a 28-day study in subjects suffering from Alzheimer's Disease to understand the safety and pharmacokinetic profile of repeat doses in patients and will include an analysis of measures of inflammation before and after treatment to provide an early indication of bioactivity."
NTRX-07 is an orally available small molecule that targets a key receptor on activated microglia, specialized cells that play an important role in the immune system of the brain. The drug reduces inflammation and improves the brain's ability to form new connections, leading to improved learning and memory. "Inflammation in the brain is increasingly recognized as an important factor in many neurological diseases, and NTRX-07 provides a new approach for the treatment of these challenging conditions," said Dr. Foss. NeuroTherapia intends to initially develop this product for the treatment of neurodegenerative diseases such as Alzheimer's Disease.
NeuroTherapia, Inc. is a Cleveland-based biotech company developing a novel small molecule, NTRX-07, for the treatment of neurodegenerative disorders. NTRX-07 is a small orally-available molecule that targets receptors known to increase in diseases including Alzheimer's disease (AD), ALS, 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. Additional information about NeuroTherapia can be found at www.neurotherapia.com.