Proprietary approach combines two neurostimulation modalities simultaneously, with the potential to enhance efficacy while reducing treatment time by 70%
Recently published Phase 1 data in healthy volunteers demonstrated significant improvement in memory, establishing the potential for this novel approach in Alzheimer’s patients
Sinaptica’s patent pending technology creates the potential for a seamless future upgrade of the SinaptiStim® System
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Sinaptica Therapeutics, Inc., a clinical-stage company leading the development of a new class of personalized neuromodulation therapeutics to treat Alzheimer’s and other primary neurodegenerative diseases, today announced that its second-generation dual stimulation technology is now being tested in a newly launched phase 2 study. The trial has enrolled its first patients and will enroll up to 60 with early-stage Alzheimer’s into this randomized, double-blind study, at multiple centers in Italy.
The second-generation technology builds on the company’s original patented, personalized and precision-delivered rTMS therapy and adds simultaneously delivered transcranial alternating current stimulation. The idea to combine the two modalities was based on over a decade of foundational research conducted by Sinaptica’s scientific co-founders into the mechanisms of memory and methods of potentiating neuroplasticity in the Default Mode Network, including the hippocampus.
This background research recently culminated in a Phase 1 proof-of-concept study in healthy volunteers. Researchers from the Santa Lucia Foundation including lead author and Sinaptica scientific co-founder Dr. Giacomo Koch, investigated this new combined stimulation in various experiments in young healthy volunteers, and were able to demonstrate impressive improvements in long-term associative memory by 60-80% versus controls, with effects durable as long as 1 week (see published results here).
“We’re continuing to innovate and evolve our precision neuromodulation therapy to provide the most effective and efficient treatment for patients,” said Giacomo Koch, MD, PhD, Sinaptica scientific co-founder, Neurologist, Professor of Physiology, University of Ferrara, and Director, Non-Invasive Brain Stimulation Laboratory, Santa Lucia Foundation. “Our goal with these improvements is to further enhance the overall efficacy of the treatment as well as reduce the time required for each treatment. We hope that this trial will expand the evidence that our neuromodulation of the DMN can be as effective – or even more effective—in early AD, as it has been in mild-to-moderate disease with the first-generation technology, published in the journal BRAIN.”
Dr. Koch and the Santa Lucia Foundation received a €1 million grant from the Italian Ministry of Health to fund this multi-center phase 2 study.
“This novel next-gen approach incorporating simultaneous stimulation has the potential to act as a future upgrade to our current therapy for Alzheimer’s and is covered by our existing patents. It’s part of our product roadmap in Alzheimer’s, other neurodegenerative diseases, and potentially in memory enhancement for healthy aging,” said Ken Mariash, Sinaptica CEO. “We have a long-term vision for the trajectory of the SinaptiStim® system that allows for increased treatment capacity, ongoing enhancement of the patient experience and continual improvements in treatment efficacy.”
About the SinaptiStim® System
The SinaptiStim® System is an investigational new approach to treating Alzheimer’s disease using non-invasive personalized precision neuromodulation. Calibrated to each individual’s brain, the therapy is delivered in weekly sessions in a recliner ranging from 20 minutes with the first-generation system to six minutes with the second-generation system. The SinaptiStim system delivers safe, painless, customized neurostimulation technology targeting the Default Mode Network (DMN), an important brain network associated with episodic memory and introspection. The technology was granted Breakthrough Device Designation by the FDA in 2022.
The company is preparing for a pivotal randomized controlled clinical trial in mild-to-moderate Alzheimer’s with its first-generation system. In this trial, the treatment will be calibrated quarterly using TMS and EEG concurrently in combination with MRI-guided neuronavigation, which enables the SinaptiStim System to achieve customized precise repeatable targeting and dosage for each patient, tracking progress and adjusting over time to achieve the best possible individualized outcomes with its nDMN therapy. The pivotal trial will also be designed to determine the effects of SinaptiStim® System on several biomarkers measuring beta amyloid, phosphorylated tau, neural inflammation, and synaptic dysfunction.
Sinaptica’s co-founder presented positive Phase 2 data after 12 months at CTAD 2024 using the first-generation system showing strong statistically significant slowing of Alzheimer’s disease progression in mild-to-moderate patients on all key gold-standard measures in all three domains: cognition, function, and behavioral disturbances (CDR-SB, ADAS-COG11, MMSE, ADCS-ADL, and NPI). These successful results were accomplished with no serious side-effects.
The second-generation system, combining both electrical stimulation and magnetic stimulation, is being evaluated in a multi-center Phase 2 study in Early Alzheimer’s disease.
About Sinaptica Therapeutics
Sinaptica Therapeutics is a clinical-stage neuromodulation therapeutics company leading the development of a new class of novel personalized therapeutics to revolutionize the treatment of Alzheimer’s and other primary neurodegenerative diseases. The company utilizes a patented non-invasive approach to treating Alzheimer’s via precision neurostimulation of a key brain network involved in memory, the Default Mode Network. Sinaptica’s scientific co-founders pioneered research on this novel approach which a growing body of evidence indicates can slow disease progression. Sinaptica’s mission is to bring a safe, effective, and non-invasive neuromodulation therapy to Alzheimer’s patients that can help to significantly slow the progression of cognitive, functional, and behavioral decline. Learn more at sinapticatx.com and follow us on LinkedIn and X @SinapticaTX.
The SinaptiStim® System is for investigational use only. It has not been approved by the U.S. Food and Drug Administration and is not available for commercial sale in any geography.
Contacts
Media:
Kathryn Morris, BrightPoint
kathryn@brightpointny.com
914-204-6412
