Synendos Therapeutics announced positive topline results from Phase 1 trials of SYT-510, marking a significant milestone as the first Selective Endocannabinoid Reuptake Inhibitor (SERI) to advance into human testing. The clinical-stage biotech company reported that its lead compound demonstrated excellent safety and tolerability while achieving meaningful central nervous system penetration and pharmacodynamic effects.
Phase 1 Trial Results Demonstrate Safety and CNS Activity
The completed Phase 1 clinical program enrolled 60 healthy volunteers across Single and Multiple Ascending Dose studies, with no drug-related safety concerns reported at any dose level. Critically, SYT-510 achieved plasma and central nervous system exposure at the anticipated pharmacological levels required for therapeutic activity.
Electroencephalogram (EEG) data provided the first evidence of SYT-510's effect on the brain, showing patterns consistent with anxiolytic medicines successfully used to control anxiety symptoms. This pharmacodynamic evidence supports the compound's potential therapeutic mechanism in neuropsychiatric conditions.
"SYT-510 is the first Selective Endocannabinoid Reuptake Inhibitors (SERIs) candidate that has advanced into humans and not only demonstrated an excellent safety and tolerability profile, but also promising pharmacokinetic properties and penetration into the central nervous system," said Dr. Andrea Chicca, Co-Founder and CEO of Synendos Therapeutics.
Novel Mechanism Targets Endocannabinoid System
SYT-510 belongs to a novel class of endocannabinoid system (ECS) modulators that restore altered ECS signaling through selective inhibition of a newly identified drug target. Unlike traditional approaches, SERIs operate through a pro-homeostatic, self-limiting mechanism of action that enables fine-tuned modulation of synaptic transmission in major neuronal circuits.
This innovative approach represents a potentially safer therapeutic strategy for multiple central nervous system disorders, including anxiety, mood disorders, and stress-related conditions. The self-limiting mechanism addresses a key unmet medical need in neuropsychiatric treatment: chronic tolerability issues that force patients to discontinue therapy.
Phase 2 Program Targets Anxiety Symptoms
Based on the positive Phase 1 results, Synendos plans to advance SYT-510 into Phase 2 trials focusing on anxiety symptoms. The upcoming study will evaluate both symptom reduction and restoration of daily function, designed to generate clinically meaningful evidence for patients.
"Our planned Phase 2 study in anxiety symptoms represents a critical step toward unlocking the therapeutic potential of SERIs across psychiatric and neurological disorders," said Dr. George Garibaldi, CMO at Synendos. "By rigorously evaluating both symptom reduction and the restoration of daily function, our program is designed to generate clinically meaningful evidence and address what matters most to patients: the ability to regain their lives and achieve their full potential."
Broader Therapeutic Potential
The successful Phase 1 program provides a foundation for evaluating SERI molecules across a spectrum of symptoms commonly observed in psychiatric and neurological disorders. Synendos is developing breakthrough therapies for neuropsychiatric and other central nervous system disorders, including anxiety disorders, PTSD, and additional indications.
The company's approach aims to combine treatment of multiple symptoms with sustained efficacy in large patient populations, potentially allowing more patients to remain on treatment and achieve improved quality of life. This dual focus on innovation and real-world impact positions Synendos to establish new benchmarks in treating disabling neuropsychiatric symptoms.
