Neuromodulation therapeutics developer Sinaptica Therapeutics has started the co-development of the SinaptiStim Precision Neuromodulation System to treat Alzheimer’s disease.
The company plans to deliver its first clinical system in March 2025 for validation testing, which will be used in forthcoming clinical trials.
SinaptiStim is being developed in partnership with Nexstim and Bittium.
Nexstim is customising the system to Sinaptica’s specifications, while Bittium is providing high-resolution, 64-channel electroencephalography (EEG) to enable precise therapy calibration for each Alzheimer’s patient.
The new system is set to feature in upcoming clinical trials targeting Alzheimer’s and other diseases, with studies scheduled to begin in 2025.
Sinaptica has developed a non-invasive neuromodulation therapy (nDMN) to treat Alzheimer’s disease. It has received breakthrough device designation from the US Food and Drug Administration (FDA).
This therapy uses personalised, precision repetitive transcranial magnetic stimulation (rTMS) to target the Default Mode Network (DMN), the primary functional brain network most impacted by Alzheimer’s.
The approach combines the patient’s MRI and concurrent EEG data to personalise treatment parameters. This method ensures accurate targeting and engagement of the DMN at a safe and effective dose specific to each patient.
Sinaptica Therapeutics CEO Ken Mariash said: “Delivery of our first investigational system is a significant tangible step forward in our mission to change the treatment landscape for Alzheimer’s.
“The SinaptiStim system takes neuromodulation to the next level, leveraging Nexstim’s elegant workflow-driven neuronavigation, integrating high-resolution EEG from Bittium, and our patented MAINTAIN cloud-based personalisation software, enabling Sinaptica to confirm propagation of evoked potentials within the brain network that drives human memory, thus inducing network-wide neuroplasticity to slow disease progression.”
The neuromodulation therapeutics developer recently presented promising 52-week Phase 2 data in October 2024.
The results showed significant slowing of Alzheimer’s disease progression in mild-to-moderate patients across all key measures, cognition, function, and behavioural disturbances.
These outcomes were achieved with no serious side effects, and no patients dropped out due to intolerance of the weekly, painless, non-invasive therapy.
Nexstim CEO Mikko Karvinen said: “We greatly value our collaboration with Sinaptica and unique customisation of the SinaptiStim system for Alzheimer’s, which has achieved the rare feat of a highly successful Alzheimer’s Phase 2 study.
“We look forward to advancing our partnership on this promising novel approach, which if successful could have a major impact on one of the largest areas of unmet need in medicine.”
