Syndeio Biosciences

Market position

The company positions synapse-targeted drug development as a powerful but underexplored therapeutic approach, and describes its NMDAR positive allosteric modulator mechanism as differentiated from NMDAR antagonist approaches such as ketamine and esketamine, as well as from other PAMs associated with overstimulation.

Syndeio bases its differentiation on event-driven pharmacology, in which a single drug dose is intended to produce lasting synaptic strengthening, and on the Boost Platform's characterization of fundamental synapse biology. Its lead candidate zelquistinel binds a unique NMDA receptor site and acts as a positive allosteric modulator, which the company presents as avoiding the severe side effects associated with NMDAR antagonists and the overstimulation associated with other PAMs.

Technology

Syndeio's core research tool is the Boost Platform, a proprietary synapse pharmacology model created out of the Stanford University laboratory of Nobel laureate Thomas C. Südhof, M.D. The platform integrates molecular, functional and behavioral models to assess how molecules affect neuronal networks and synaptogenesis, and the company uses the resulting data to characterize synapse-targeted drug candidates, predict clinical outcomes and de-risk development programs. Clinical development applies precision-neuroscience methods including objective biomarkers, quantitative EEG and brain wave analysis, machine learning, polysomnography, targeted enrichment for patient subpopulations and symptom clusters, and genetically defined disease targets. The company is a clinical partner of Beacon Biosignals and uses that company's FDA 510(k)-cleared DREEM 3S device for biomarker capture in its trials.

Go-to-market

Patients with synaptopathies — neuropsychiatric, mental health and cognitive disorders including major depressive disorder, Alzheimer's disease and schizophrenia; current clinical trials enroll adults with major depressive disorder at U.S. sites.

Geography

Clinical trials are conducted in the United States, with nearly 30 sites per zelquistinel Phase 2 study and a Phase 2a apimostinel collaboration with the University of Pittsburgh.

History

The Boost Platform originated from the Stanford University laboratory of Nobel laureate Thomas C. Südhof, M.D., who serves as co-chair of the company's Scientific Advisory Board. Derek Small is co-founder and Chief Executive Officer. Leadership also includes Michael McCully as President and Chief Operating Officer and John Donello, Ph.D., as Chief Science Officer. The board of directors is chaired by Mark DiPaolo, Esq. (chairperson of the board of Innoviva) and includes Pavel Raifeld (CEO of Innoviva), Jacob Vogelstein, Ph.D. (co-founder and managing partner of Catalio Capital Management), Derek Small and Michael McCully. Scientific and clinical advisors include Anantha Shekhar, M.D., Ph.D. (Chief Scientific Advisor), Steve Brannan, M.D. (Chief Medical Advisor), Robert Berman, M.D. (Senior Clinical Advisor) and Joseph Moskal, Ph.D. (co-chair of the Scientific Advisory Board).