Synendos Therapeutics Reports Positive and Highly Promising Topline Results from Phase 1 Trials, Paving the Way for Phase 2 in Mental Health

• The studies established the lead asset to be well tolerated in healthy volunteers at all doses with a good safety profile
• SYT-510 demonstrated penetration in the central nervous system and a pharmacodynamic effect on the brain

BASEL, Switzerland, Sept. 24, 2025 (GLOBE NEWSWIRE) — Synendos Therapeutics (“Synendos”), the clinical-stage biotech company developing breakthrough therapies for neuropsychiatric disorders, announced today topline results for its lead asset, SYT-510, a first-in-class inhibitor that modulates a newly identified drug target in the Endocannabinoid System that helps restore healthy brain functions.

Synendos successfully completed its Phase 1 clinical program in healthy volunteers, following the pre-clinical development of its lead compound SYT-510, and regulatory approval received from the EMA and MHRA.

Initial key findings include:

• 60 healthy volunteers were dosed in the Single and Multiple Ascending Dose studies with no drug-related safety concerns.
• Plasma and central nervous system exposure reached the anticipated pharmacological levels for activity. 
• The effect of SYT-510 on electroencephalograms (EEG), showed an effect on the brain consistent with that seen with anxiolytic medicines used successfully to control anxiety symptoms. 

Dr. Andrea Chicca, Co-Founder and CEO of Synendos Therapeutics, said, “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. Furthermore, the EEG data provide first evidence of an effect on the brain. Overall, this clinical result is very encouraging for our upcoming Phase 2 trial where we plan to demonstrate the validity of the first-in-class SERI mode of action in patients.”

The completed pre-clinical and Phase 1 studies provide a strong foundation and rationale for advancing Synendos’ clinical program to evaluate the efficacy of SERI molecules across a spectrum of symptoms commonly observed in psychiatric and neurological disorders.

“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.”

Through this dual focus on innovation and real-world impact, Synendos aims to set a new benchmark in how disabling symptoms are treated and managed.

About Synendos
Synendos is a clinical-stage, neuroscience company developing breakthrough therapies for neuropsychiatric and other central nervous system (CNS) disorders such as anxiety disorders, PTSD and other indications. We utilize the modulation of a new drug target in the endocannabinoid system (ECS) that enables restoration of the natural functioning of the brain. Synendos’ lead drug candidate, SYT-510, belongs to a novel class of ECS modulators named Selective Endocannabinoid Reuptake Inhibitors (SERIs). SERIs represent first-in-class, new chemical entities that modulate the ECS through a self-limiting mode of action (MoA) with the potential to deliver meaningful benefits to patients. This novel MoA has the potential to combine treatment of a range of symptoms with sustained efficacy in large patient populations together with the potential to address a key unmet need, that of chronic tolerability, allowing more patients to stay on treatment and regain an improved quality of life. synendos.com

About SERIs
Our lead candidate, SYT-510, belongs to a novel class of ECS modulators named SERIs. SERIs are first-in-class endocannabinoid system (ECS) modulators that restore altered ECS signaling in disease conditions with a gentle and selective increase of endocannabinoid levels by inhibiting a newly identified drug target. SERIs act with a pro-homeostatic, self-limiting mechanism of action that enables a fine-tuned modulation of synaptic transmission in major neuronal circuits in the CNS. SERIs’ new mode of action represents an innovative and potentially safer therapeutic approach to multiple CNS disorders such as anxiety, mood and stress-related conditions, and others.

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