NeuroTherapia to Present Phase 2a Alzheimer's Disease Clinical Data at the AAIC 2026 Conference in London, UK

Encouraging Data Demonstrating Target Engagement will be Presented in a Poster on Monday July 13ᵗʰ

CLEVELAND, July 13, 2026 /PRNewswire/ -- NeuroTherapia, Inc., a clinical-stage company focused on developing oral therapies for neurodegenerative diseases, will be presenting data from its recently completed Phase 2a clinical trial in Alzheimer's Disease (AD) at the Alzheimer's Association International Conference (AAIC) 2026 during the Monday July 13^th poster session. The trial was a 28-day, multicenter, randomized, double-blind, placebo-controlled study designed primarily to evaluate the safety, tolerability, and pharmacokinetics of NTRX-07 in 48 participants with mild cognitive impairment or mild-to-moderate AD, randomized 1:1 to NTRX-07 (90 mg/day) or placebo. The study also included a set of pre-specified exploratory biomarkers, neuroimaging, and cognitive endpoints intended to characterize pharmacodynamic activity and to inform the design of future controlled trials.

In preclinical AD models, NTRX-07 was shown to modulate neuroinflammation, promote amyloid clearance, and improve neuronal function. To explore whether comparable pharmacodynamic activity could be observed in patients, the Phase 2a study evaluated diffusion MRI and cerebrospinal fluid (CSF) biomarkers.

Diffusion MRI was used as an exploratory measure of neuroinflammation and neurodegeneration. Across several brain regions, descriptive analyses favored the NTRX-07 group on measures of neuroinflammation, with some areas showing statistically significant changes and other demonstrating directionally consistent trends toward reduced neurodegeneration. In an exploratory analysis within the treated arm, participants classified as responders showed patterns distinguishing them from non-responders on regional neuroinflammation and neurodegeneration measures, most notably in the superior parietal region — a region previously reported to show a strong correlation between the microglial marker sTREM2 and a diffusion-MRI measure of neuroinflammation (Ridgeway et al., 2024, CTAD, conference abstract). These observations warrant confirmation in a larger controlled study.

The neuroimaging observations were accompanied by directionally consistent CSF biomarker patterns. Neurofilament light chain (NfL) remained stable or decreased in the NTRX-07 group while increasing in the placebo group over the 28-day period, and the Aβ42/Aβ40 ratio showed a within-group increase following NTRX-07 treatment, a pattern consistent with altered amyloid dynamics. Descriptive analyses also indicated a treatment-associated reduction in neuroinflammatory biomarkers, including IL-6 and YKL-40. These findings support the anti-inflammatory mechanism of NTRX-07 and will guide subsequent trials.

"We are encouraged that NTRX-07's safety and pharmacokinetic profile was confirmed in AD patients, and that the exploratory biomarker and imaging signals point in a direction consistent with the anti-neuroinflammatory activity we observed in animal models," said Dr. Joseph Foss, NeuroTherapia's Chief Medical Officer. "I look forward to presenting the full dataset at AAIC in London."

NTRX-07 was safe and well tolerated over the 28-day treatment period and drug exposure levels were consistent with the target range established in previous studies.

"With a clean safety profile and pharmacodynamic signals consistent with our mechanism, we are excited to advance NTRX-07 into the next stage of controlled clinical development in AD," added Tony Giordano, Ph.D., the Company's CEO. "By showing pharmacodynamic activity relevant to neuroinflammation in human disease, we also see potential to explore NTRX-07 across other neuroinflammatory conditions."

NTRX-07 is a small, orally available molecule that selectively activates CB2, which in turn drive microglia (key immune cells in the brain) into an anti-inflammatory state 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, 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.

This study was being funded in part by a grant from the Alzheimer's Association Part the Cloud program.¹

About NeuroTherapia

At NeuroTherapia, our mission is to develop treatments that will improve the course of the most debilitating and deadly central nervous system (CNS) diseases patients and their families face today. NeuroTherapia, Inc. is a clinical-stage, privately held biotechnology company, spun out of the Cleveland Clinic, developing oral, small-molecule drugs to address neuroinflammatory conditions of the CNS, including Alzheimer's disease, Parkinson's disease, amyotrophic lateral sclerosis, and other CNS disorders. There is an emerging consensus that neuroinflammation plays a significant role in CNS disease. NeuroTherapia is a leader in developing novel therapeutics that modulate microglial activity, impacting the expression of proteins that drive inflammation in the CNS, thereby improving neuronal function and survival. Additional information about NeuroTherapia can be found at www.neurotherapia.com.

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SOURCE NeuroTherapia, Inc.