Company accelerates after unprecedented positive Phase 2 data in Alzheimer’s, showing >80% disease slowing on cognitive & functional endpoints
CAMBRIDGE, Mass.-– Sinaptica Therapeutics, Inc., a clinical-stage company leading the development of a new class of personalized neuromodulation therapeutics to treat Alzheimer’s and neurodegenerative diseases, announces the appointment of Ken Mariash Jr. as Chief Executive Officer. Mariash brings more than 25 years of life sciences leadership experience in strategy, corporate development, and marketing, both in medtech and biotech, at companies such as CSL Behring, Baxter BioScience, and Boston Scientific, including over a decade in the neuromodulation space.
Mariash takes on the role of CEO at a time of long-awaited progress for Alzheimer’s disease (AD) treatments, and as Sinaptica’s scientific co-founders have recently published positive Phase 2 data in Alzheimer’s, showing greater than 80% disease slowing on all four gold-standard cognitive and functional clinical endpoints, in the peer-reviewed Oxford University Press journal, Brain.
As Chief Executive Officer, Mariash joins the company to accelerate clinical product development of the company’s SinaptiStim™ System, a closed-loop neuromodulation therapy that utilizes a novel approach to treating AD by enhancing neuroplasticity via neurostimulation of key brain networks involved in memory. The SinaptiStim System was granted FDA Breakthrough Device Designation in 2022.
“I’m excited to take on this leadership role at Sinaptica at a time when our mechanistic understanding of AD pathology is evolving – the world is starting to appreciate new targets and new approaches like neuromodulation, which have the potential to significantly bend the curve of disease progression,” said Mariash. “After decades of drug failures, we applaud the recent progress of those targeting amyloid; however there remains a massive unmet need for safe, effective – and perhaps complementary – approaches.”
Sinaptica’s scientific co-founders are leaders in the use of novel diagnostic and therapeutic approaches to treating AD using noninvasive neurostimulation techniques. They have completed multiple clinical trials over the past 10 years, culminating in the recent groundbreaking placebo-controlled Phase 2 study in mild-to-moderate AD patients. Sinaptica was founded to fully develop the SinaptiStim System and clinical protocol behind this breakthrough approach. The Company is on track to initiate a pivotal study of the System in the first half of 2024.
“As Sinaptica prepares for a pivotal clinical trial of our closed-loop neuromodulation therapy, Ken is the ideal choice to lead the company through this important stage,” said Rich Macary, President of Sinaptica Therapeutics. “He brings a rare combination of drug, device, neuromodulation, and AD experience together with a broad skill set ranging from product development to capital equipment commercialization. We have incredible confidence in Ken’s ability to take Sinaptica through the development stage toward commercialization, and that his leadership will guide the company to realize the full potential of this transformative therapy to impact the lives of patients with Alzheimer’s disease.”
Before joining Sinaptica, Ken was Founder & Managing Partner of Rubicon Strategy Partners, a consulting firm advising large and small medtech companies. Prior to that, he was employee #2 and Vice President of Marketing at EBT Medical, where he oversaw all commercial aspects as the company developed a noninvasive neuromodulation therapy for overactive bladder, from initial design idea to verification and validation. Prior to EBT, Mariash was Director, Strategy and New Markets for the nearly $1B Neuromodulation division of Boston Scientific. There, he was the global commercial lead for the highly successful Cosman RF ablation business, which he helped acquire. He also built the division’s Strategy function, providing leadership in areas including strategic planning, BD assessment, R&D portfolio management, digital strategy, and investments in next-gen platforms and new indications. Before Boston Scientific, Mariash was in Strategy & Business Development at Baxter BioScience (now Takeda), evaluating and championing acquisitions and driving business planning for multiple franchises. Ken’s early career had positions of increasing responsibility at CSL Behring and Charles River Associates. He holds degrees in Biochemistry & Business Economics from Brown University.
About the SinaptiStim™ System
The SinaptiStim™ System is a revolutionary new approach to treating Alzheimer’s disease using personalized precision closed-loop neuromodulation. Calibrated to each individual’s brain, this noninvasive therapy is delivered weekly in 25-minute sessions in a recliner, with safe, painless, customized neurostimulation technology targeting prescribed areas of the precuneus section of the brain. The precuneus is the central hub of the Default Mode Network (DMN), an important brain network associated with episodic memory and introspection. There has been a tremendous amount of recent research identifying the DMN as playing a central role in AD pathology and progression. It is thought that electrically stimulating the DMN increases neuroplasticity and stabilizes the brain’s electrical network, helping build new memory pathways and connections.
The treatment is calibrated every few months using TMS and EEG in combination with MRI-guided neuronavigation that enables the SinaptiStim™ System to achieve customized precise targeting and dosage for each patient, tracking progress and adjusting over time to achieve the best possible individualized outcomes.
About Sinaptica Therapeutics
Sinaptica Therapeutics is a clinical-stage neuromodulation therapeutics company leading the development of a new class of personalized therapeutics to revolutionize the treatment of Alzheimer’s and neurodegenerative diseases. The company’s SinaptiStim™ System utilizes a novel, noninvasive approach to treating AD via neurostimulation of key networks in the brain, enhancing neuroplasticity and slowing disease progression by >80% on all four gold-standard cognitive and functional clinical endpoints in a placebo-controlled clinical study, with results published in the peer-reviewed journal Brain. The SinaptiStim™ System was granted Breakthrough Device Designation by the FDA in 2022 and the company is preparing for a pivotal randomized controlled clinical trial in 2024. Sinaptica’s mission is to bring a safe, effective, and noninvasive neuromodulation therapy to Alzheimer’s patients that can help to significantly slow the progression of both cognitive and functional decline. Follow us on LinkedIn and Twitter @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.