Neurocentria Obtains FDA Approval to Conduct Pivotal Phase 2b/3 Clinical Trial for Testing Safety & Efficacy of Drug Candidate NRCT-101SR in Adults With ADHD

Neurocentria Inc. has recently received FDA approval to conduct a pivotal Phase 2b/3 human clinical trial to test the efficacy and safety of its leading drug candidate NRCT-101SR compared to inactive placebo in adults with ADHD.

ADHD is a neurodevelopmental disorder characterized by deficits in attention, impulsive behaviors and hyperactivity. Existing approved medications for ADHD have limited utility. Stimulants, the current first-line standard of care, result in a 30%-50% discontinuation rate, often due to the medications’ side effects. Only circa 10% of adults diagnosed with ADHD are treated. Thus, there is a significant unmet medical need for new effective treatments with a good tolerability profile.

Currently available treatments for ADHD act on monoamine synapses, a classical target identified decades ago. No novel approaches have been introduced into the market during this time. NRCT-101, the active pharmaceutical ingredient (API) of NRCT-101SR, is being developed as a new class of drug, acting on glutamatergic synapses, a novel target. Preclinical studies indicate that NRCT-101 treatment increases glutamatergic synaptic density, function and plasticity in the prefrontal cortex and hippocampus, resulting in improved cognitive function and emotional regulation.

This randomized, double-blind, placebo-controlled clinical trial builds on multiple previous human trials in both younger and older adult populations in which NRCT-101SR treatment improved cognition and overall mood status, including reduction of depression and anxiety symptoms. In particular, in a study conducted at Harvard/Massachusetts General Hospital in ADHD patients, NRCT-101SR significantly reduced ADHD core symptoms. Safety data collected from more than 200 individuals in multiple studies revealed that NRCT-101SR is well-tolerated with an overall strong safety profile and fewer adverse events compared to placebo. This would be a key advantage compared to the current ADHD treatments that have significant side effects if it is confirmed through further clinical studies.

“This is an exciting time for Neurocentria as we initiate a pivotal phase IIb/III trial to test our novel therapy for adults with ADHD,” said Dr. Guosong Liu, Founder and CEO. “We are confident our drug candidate will address a major unmet medical need for these people, which often leave them saddled with significant side effects and without improving their quality of life. Considering the significant side effects of current medications, the need is great for new drugs that will improve ADHD core symptoms, executive function, overall cognitive performance and mood status, with a good tolerability profile, allowing people in need to be treated.”

In early-stage human clinical trials, NRCT-101 was shown to:

• Address ADHD symptoms without imposing side effects on the patient.
• Improve mood status in three to seven days versus the several weeks it takes for most mood medications.
• Improve cognition for adults with various neurodegenerative and neuropsychiatric disorders, including ADHD.
• Produce no reported adverse side effects relative to placebo.

The FDA also recently approved Neuocentria’s drug candidate for a Phase IIb human trial in Alzheimer’s disease. The company is working on approval for a Phase 2b/3 human trial in adults with late-life depression. The company plans to enroll subjects in the three placebo-controlled studies, starting with the ADHD human clinical trial, in the third quarter of 2022.

Neurocentria is a late-stage biotechnology company dedicated to discovering and developing novel treatments for neurodegenerative and neuropsychiatric disorders, including Alzheimer’s disease, ADHD and depression. Since 2005, Neurocentria’s team has been innovating breakthrough therapies to address the pathophysiology of these disorders, prevent their progression or even reverse their course, reduce symptoms and improve performance and quality of life for those in need.