NeuroTherapia, Inc. today announced the presentation of clinical data from its Phase 1b clinical trial of NTRX-07, an oral, small molecule CB2-targeting therapy in development for the treatment of Alzheimer’s disease (AD), in healthy volunteers and a subset of patients with mild cognitive impairment or early AD, at the Clinical Trials on Alzheimer’s Disease (CTAD) conference, taking place in Boston, Mass., Oct. 24-27, 2023.
Overall positive safety profile supports advancement into Phase 2 clinical study
Levels of NTRX-07 detected in the plasma correlate with levels expected to drive efficacy based on preclinical studies
Measures of cognitive function suggest a trend toward improvement in Alzheimer’s disease patients treated with NTRX-07
CLEVELAND, Oct. 24, 2023 (GLOBE NEWSWIRE) -- NeuroTherapia, Inc., a clinical-stage, privately held biotechnology company developing oral, small molecule drugs to address neuroinflammatory conditions of the central nervous system (CNS), today announced the presentation of clinical data from its Phase 1b clinical trial of NTRX-07, an oral, small molecule CB2-targeting therapy in development for the treatment of Alzheimer’s disease (AD), in healthy volunteers and a subset of patients with mild cognitive impairment or early AD, at the Clinical Trials on Alzheimer’s Disease (CTAD) conference, taking place in Boston, Mass., Oct. 24-27, 2023.
Data from the study demonstrated a favorable safety profile at all dose ranges, a pharmacokinetic (PK) profile consistent with preclinical studies and in line with levels expected to drive clinical activity, and a trend toward cognitive improvement in the AD patients that were treated with NTRX-07.
“We are very encouraged by the strong safety profile observed in this study and by the levels of NTRX-07 we observed in the plasma of the participants and patients in the study. The early signs of clinical activity we observed in the AD patients included in the study were even more encouraging. Of particular interest was the finding that NTRX-07 treatment partially reversed some of the qEEG changes, an accepted measure of cognitive function, that are associated with AD, " said Tony Giordano, Ph.D., President and CEO of NeuroTherapia. “We look forward to advancing NTRX-07 into a Phase 2 study where we can further evaluate clinical activity in patients in the hopes of bringing a novel therapy forward that has the potential to work synergistically with approved antibody treatments.”
Summary of study results:
- 32 participants, including one cohort of 8 patients with early-stage AD, received NTRX-07 or a placebo for seven days in a double-blind, randomized clinical study.
- The safety profile of NTRX-07 supports further clinical development, with no dose-limiting or serious adverse events observed during the trial. Across all dose levels (10mg, 30mg, or 90 mg), adverse events were mild and transient, and no participants discontinued treatment, with the exception of one who withdrew for personal reasons.
- PK demonstrated that levels of NTRX-07 in the plasma were within the target ranges expected to drive efficacy based on the preclinical data.
- Several cognitive function measures were evaluated within the cohort of AD patients. While the trial was not powered to detect a significant change in cognitive scores, an interesting trend toward improvement was observed in AD participants using the Alzheimer’s Disease Assessment Scale–cognitive subscale (ADAS-Cog) test. Of 6 treated patients tested with ADAS-Cog, all 6 showed a reduction in the number of errors following treatment, with 3 having clinically meaningful improvements (3-4 point score reduction). In contrast, neither of the non-treated AD patients showed an improvement. A post-hoc analysis was carried out on electroencephalogram (EEG) data collected for safety analysis, which showed that following treatment with NTRX-07, patients evaluated with quantitative electroencephalogram (qEEG) demonstrated a partial reversal of the lowering of mean frequency known to exist in AD patients.
“There is an emerging consensus that neuroinflammation is a driver of CNS diseases, including AD. While most therapies have focused on removing amyloid, the AD community is beginning to recognize that combination treatments, including anti-inflammatory therapies, could be very beneficial,” said Joseph Foss, M.D., Chief Medical Officer of NeuroTherapia. “This data gives us additional confidence that NTRX-07 could become a valuable treatment option and based on its safety profile, could be used in combination with approved antibody treatments.”
About NTRX-07
NTRX-07 is an orally available small molecule that targets a key receptor on activated microglia, specialized cells that play an important role in regulating immune system activity in the CNS. 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. NeuroTherapia is initially developing this product for the treatment of Alzheimer’s disease.
About NeuroTherapia
NeuroTherapia is a clinical-stage, privately held biotechnology company developing oral, small-molecule drugs to address neuroinflammatory conditions of the central nervous system (CNS), including Alzheimer’s disease, Parkinson’s disease, amyotrophic lateral sclerosis, and other CNS conditions. There is an emerging consensus that neuroinflammation plays a significant role in CNS disease. NeuroTherapia is developing therapeutics that inhibit microglia cells, which are known to express proteins that drive inflammation in the CNS, without affecting the clearance of toxic beta amyloid. We believe this approach will result in improved neuronal function and survival. At NeuroTherapia, our mission is to change the course of the most debilitating and deadly CNS diseases that patients and their families face today.
For more information, please visit www.neurotherapia.com.
Media Contact:
Cory Tromblee, Scient PR
cory@scientpr.com
