NeuroTherapia Secures EMA Approval for Phase 2 Alzheimer's Treatment Trial

NeuroTherapia, Inc., a company specializing in oral therapies for neurodegenerative diseases, recently announced that it has received approval from the European Medicines Agency (EMA) for its Phase 2 clinical trial aimed at treating Alzheimer’s Disease (AD). This trial will examine the effects of the lead molecule, NTRX-07, on patients suffering from AD over a span of 28 days.

The double-blind, randomized trial will not only track safety and pharmacokinetics but also measure clinical efficacy through established tests like ADAS-cog, MMSA, and Trials Making Test. A significant goal of the trial is assessing target engagement using various biomarkers related to neuroinflammation and neuronal function.

Dr. Joseph Foss, the Chief Medical Officer at NeuroTherapia, expressed enthusiasm about the trial's potential: “Following some promising results in our Phase 1b trial that showed improvements in neuronal function, we are eager to see if these trends will be sustained with a larger patient group and an extended treatment period.”

The trial will be managed by CRU Global, a well-respected European Contract Research Organization (CRO), with sites located in Hungary, Poland, and the Czech Republic. Initial training for employing qEEG and P300 ERP recordings is underway, and participant recruitment is expected to commence soon. Investigators involved in the trial are looking forward to exploring how NTRX-07 could benefit their patients, thanks to its innovative approach and encouraging data from earlier studies.

Tony Giordano, President and CEO of NeuroTherapia, emphasized the dire need for effective treatments for Alzheimer’s: “AD remains a devastating disease with few good treatment options. We hope this trial will not only showcase our novel neuroinflammatory inhibitor’s potential but also help us pinpoint specific biomarkers that could inform treatment decisions in future studies.”

NTRX-07 functions as a small, orally available molecule targeting receptors that become more prevalent in diseases like Alzheimer's, amyotrophic lateral sclerosis (ALS), and multiple sclerosis (MS). Animal studies have demonstrated that NTRX-07 can restore normal microglial function—vital immune cells in the brain—effectively reducing inflammation, cutting down Alzheimer-associated Ab peptide levels, and significantly enhancing neuronal plasticity, learning, and memory functions.

Trials 1a and 1b have indicated a favorable tolerance for NTRX-07 among participants at dosages anticipated to be efficacious based on preclinical modeling. This research initiative has received partial funding through a grant from the Alzheimer’s Association's Part the Cloud program, reflecting a strong community interest in advancing Alzheimer's treatments.

NeuroTherapia, based in Cleveland, Ohio, is a clinical-stage biotechnology firm originating from the Cleveland Clinic. It focuses on developing oral drugs that target neuroinflammatory conditions affecting the central nervous system, which includes Alzheimer’s, Parkinson’s, ALS, and other similar disorders. By addressing neuroinflammation—a growing consensus issue related to CNS diseases—NeuroTherapia aims to enhance neuronal function and patient outcomes.

With a mission centered around improving the lives of those suffering from CNS diseases, NeuroTherapia is paving the way for innovative therapies designed to tackle this critical health challenge. More information about NeuroTherapia can be found on their website: www.neurotherapia.com.