Reimagining brain health through new insights into synaptic biology

Innovation

New Category of Transformative Treatments

Syndeio is a synapse-focused biotech pioneering a new class of therapies for neuropsychiatric and cognitive disorders. Through unparalleled expertise in fundamental synapse biology and a leading synapse pharmacology platform, we are developing drug candidates with new, differentiated mechanisms of action.

Our key innovation is harnessing event-driven pharmacology—a mechanism where a single drug dose triggers lasting biological changes that strengthen the connection between neurons. This approach opens new possibilities for creating rapid-acting, safe, and effective therapies.

Enhancing Synaptic Health

Healthy brain function depends on the strength and maintenance of synapses, or connections between neurons. “Synaptopathies”, or diseases characterized by synaptic weakening and loss such as depression, Alzheimer’s, and schizophrenia, collectively impact over one billion people worldwide.

Our drug candidates are designed to restore brain health by activating the brain’s ability to form new neural connections.

Targeting the synapse is a powerful but underexplored therapeutic approach. We aim to develop transformative therapies by leveraging faster, safer, and more effective mechanisms to strengthen synapses.

Novel Insights into Synapse Biology

The Boost platform enables fine-tuned modulation of synapse biology to optimize connections between neurons.

Boost™, our proprietary synapse pharmacology platform enables unparalleled understanding of fundamental synapse biology and pharmacology.

Created out of the Standard University laboratory of Nobel laureate Thomas C. Südhof, M.D., the platform integrates molecular, functional, and behavioral models to explore how molecules impact neuronal networks and synaptogenesis.

The data provided by Boost have created a new foundation of knowledge that more deeply characterizes synapse-targeted drug candidates and applies these unparalleled insights to predict clinical outcomes and de-risk development of our current and future programs.

Pipeline and clinical studies

Pipeline

Syndeio Biosciences is redefining the landscape of synapse-targeted drug development. Our pipeline of precision neurotherapeutics addresses synaptic dysfunction driving mental health, neuropsychiatric, and cognitive disorders.

Targeted Medicine

Our development approach optimizes patient outcomes through precision neuroscience that includes the use of objective biomarkers as well as cutting-edge tools such as quantitative EEG and brain wave analyses, machine learning, polysomnography, targeted enrichment for patient subpopulations and symptom clusters, and genetically defined disease targets.

We are a proud clinical partner of Beacon Biosignals and employ their FDA 510(k)-cleared DREEM 3S device to capture biomarkers in our clinical studies.

Ongoing Clinical Development

- A potential best-in-class oral molecule for enhancing synaptic function, zelquistinel is being evaluated in a Phase 2 study in major depressive disorder (MDD), which is currently enrolling across nearly 30 sites in the U.S. (NCT06547489), and will soon enter a first-of-its-kind synaptic function biomarker trial in Alzheimer’s disease.
- Zelquistinel binds to a unique site on the NMDA receptor (NMDAR), the brain’s primary receptor for the excitatory neurotransmitter glutamate. By acting as a positive allosteric modulator, zelquistinel directly enhances glutamate signaling and improves synaptic function.
- Zelquistinel’s NMDAR PAM mechanism is highly differentiated from other NMDAR-targeted approaches by mitigating the severe side effects of antagonists (e.g., ketamine) and overstimulation by other PAMs. Dosing of 500 study participants across 3 clinical trials has established a favorable tolerability profile.
- Apimostinel is an NMDAR positive allosteric modulator (PAM) that can be delivered as a potent, rapid-acting injectable for the treatment of severe CNS disorders.
- Completion of three clinical trials has established a potential best-in-class safety and efficacy profile for the acute treatment of depression compared to ketamine/esketamine.
- An ongoing Phase 2a trial, in collaboration with the University of Pittsburgh, is evaluating the potential for longer-lasting outcomes by pairing apimostinel with a digital therapy that enhances neuroplasticity-driven benefits.

Our Team

Leading with Experience

Our team has long been at the forefront of neurology drug development with unmatched expertise in translating synaptic biology into impactful therapies.

FOUNDING
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