NeuroTherapia, Inc. and Sinaptica Therapeutics are making strides in Alzheimer's disease treatment with their respective therapies entering Phase 2 clinical trials. These developments offer hope for addressing the unmet needs in managing this devastating neurodegenerative condition.
NeuroTherapia's NTRX-07 Enters Phase 2 with EMA Approval
NeuroTherapia, a clinical-stage company focused on oral therapies for neurodegenerative diseases, announced that the European Medicines Agency (EMA) has approved its Phase 2 clinical trial for NTRX-07. NTRX-07 is the company's lead molecule, designed to target neuroinflammation, a key factor in Alzheimer's disease progression. The double-masked, randomized clinical trial will administer NTRX-07 to Alzheimer's disease participants for 28 days.
The trial will monitor safety, pharmacokinetics, and clinical efficacy using standard measures such as ADAS-cog, MMSA, and Trails Making Test. Additionally, the trial aims to identify biomarkers in the cerebrospinal fluid (CSF) that correlate with changes in neuroinflammation, assessed via MRI, or improvements in neuronal function, measured by quantitative EEG (qEEG). According to Dr. Joseph Foss, NeuroTherapia's Chief Medical Officer, this would demonstrate that NTRX-07 reduces neuroinflammation and improves neuronal function, similar to preclinical findings.
The trial will be managed by CRU Global and conducted in Hungary, Poland, and the Czech Republic. Tony Giordano, Ph.D., NeuroTherapia's President and CEO, expressed hope that the trial will demonstrate the potential of NTRX-07 and identify biomarkers to select patients who may benefit most from the treatment. NTRX-07 is an orally available molecule that, in animal models, has shown promise in restoring normal microglial function, reducing inflammation, and improving synaptic plasticity, learning, and memory.
Sinaptica's Dual Neuromodulation System Advances to Phase 2
Sinaptica Therapeutics, Inc., a clinical-stage company focused on personalized neuromodulation therapeutics, has initiated enrollment in its Phase 2 clinical trial for its second-generation SinaptiStim® system. This system combines repetitive transcranial magnetic stimulation (rTMS) with transcranial alternating current stimulation, potentially enhancing efficacy and reducing treatment time by up to 70%.
The trial will enroll up to 60 patients with early-stage Alzheimer's disease in a randomized, double-blind study across multiple centers in Italy. The dual stimulation technology builds on Sinaptica's original rTMS therapy, targeting the Default Mode Network (DMN), a key brain network associated with memory. A Phase 1 study in healthy volunteers demonstrated significant improvements in long-term associative memory (60-80%) with effects lasting up to one week.
Dr. Giacomo Koch, Sinaptica's scientific co-founder, noted that the goal is to enhance treatment efficacy and reduce treatment time. Ken Mariash, Sinaptica CEO, added that this next-generation approach could be a future upgrade to their current therapy and is part of a broader product roadmap. The SinaptiStim® System has received FDA Breakthrough Device Designation and delivers personalized neurostimulation targeting the DMN. Sinaptica is also preparing for a pivotal trial with its first-generation system in mild-to-moderate Alzheimer's, assessing effects on biomarkers like beta amyloid, phosphorylated tau, neural inflammation, and synaptic dysfunction.
Sinaptica's co-founder presented positive Phase 2 data at CTAD 2024 using the first-generation system, showing statistically significant slowing of Alzheimer's disease progression across key clinical measures, with no serious side effects.
