Clinical stage biotech gears up for industry first Alzheimer’s trial using synaptic function biomarkers as endpoints.
Precision neurotherapeutics company Syndeio Biosciences launched today with a mission to restore and enhance synaptic function in central nervous system disorders. Backed by more than $90 million in funding, the clinical-stage company is advancing a pipeline of therapies designed to address “synaptopathies” – disorders characterized by weakened or lost synaptic connections that underlie a wide range of CNS conditions, including Alzheimer’s and depression.
Syndeio, which appears to be the new identity of ‘stealth biotech’ Gate Neurosciences following its acquisition of Boost Neuroscience earlier this year, aims to repair disrupted neural networks by strengthening synapses – the essential junctions between neurons that support brain function.
“Synaptopathies – diseases rooted in synaptic dysfunction – including major depressive disorder, Alzheimer’s disease, schizophrenia, and others, affect more than a billion people globally and represent a pressing public health crisis,” said Syndeio CEO Derek Small. “Targeting the synapse offers a powerful but underexplored pharmacological approach to treating these conditions. Our scientific founders have uncovered critical nuances in translating the biology of synaptic plasticity into effective therapeutics.”
The company’s approach is built around a proprietary platform, originally developed at Stanford University in the laboratory of Nobel Laureate Dr Thomas Südhof, which integrates electrophysiological, behavioral and human neuronal network assays to assess the impact of drug candidates on synaptic biology.
“The fields of neurology and psychiatry are converging on an understanding of synaptic function as one of the most important drivers of brain health,” said Südhof, who co-chairs Syndeio’s Scientific Advisory Board. “Still, a lack of high-quality preclinical models has long impeded neurology drug development. The preclinical models of Syndeio’s Boost Platform provide translatable data predicting clinical outcomes across numerous compounds, increasing our confidence in the potential therapeutic benefits of each of Syndeio’s current and future programs.”
Syndeio’s lead candidate, zelquistinel, is currently undergoing a Phase 2 clinical trial for major depressive disorder and is also slated to enter a biomarker-driven trial in Alzheimer’s disease. The company claims the upcoming Alzheimer’s study will be the first to use synaptic function biomarkers as endpoints. Prior clinical studies of zelquistinel have shown it to rapidly and durably enhance synaptic plasticity, and the compound has demonstrated promising activity along with measurable biomarker effects.
Syndeio uses quantitative EEG, brain wave analysis, machine learning and other advanced technologies to refine patient targeting and optimize treatment strategies. The company partners with Beacon Biosignals to incorporate the company’s wearable devices into its clinical protocols, enabling real-time capture of neurological biomarkers and improving trial precision.
Syndeio says it has secured more than $90 million in funding from a consortium of life science investors and strategic stakeholders that includes Catalio Capital Management, Innoviva, AbbVie and Lilly.
“The strength of Syndeio’s scientific platform and clinical pipeline has the potential to reshape the landscape of synapse-targeted drug development,” said Catalio’s Jacob Vogelstein. “This is a world-class team with unmatched expertise in translating synaptic biology into impactful therapies.”
