Synendos Therapeutics AG Granted EMA Clinical Trial Authorisation for first-in-class Endocannabinoid System modulator, SYT-510

• Synendos Therapeutics transitions to a clinical-stage biotech company developing innovative Endocannabinoid System (ECS) treatments for neuropsychiatric, neuroinflammatory and other Central Nervous System (CNS) disorders
• Clinical Trial will investigate the safety, tolerability and pharmacokinetics of Synendos' first-in-class ECS modulator

BASEL, Switzerland, Jan. 18, 2024 /PRNewswire/ -- Synendos Therapeutics AG (Synendos), a world leader in innovative Endocannabinoid System (ECS) treatments, today announces that it has received approval from the European Medicines Agency (EMA) to commence the Phase 1 'first-in-human' clinical trial of its lead asset, SYT-510, a first-in-class inhibitor that modulates a newly identified drug target in the Endocannabinoid System to restore healthy brain physiology.

The randomized, double-blind, placebo-controlled study will investigate the safety, tolerability and pharmacokinetics of single-ascending doses of SYT-510 in healthy adult participants.

Synendos is developing selective endocannabinoid reuptake inhibitors (SERIs) that influence the balance of the ECS in a novel mode of action.  The ECS is a key neuromodulator system in the CNS which plays a significant role in how the body responds to stress.  By rebalancing and restoring endogenous cannabinoid levels that are dysregulated in certain pathological conditions, this new mode of action has the potential to rebalance brain function in a holistic and pro-homeostatic way to treat neuropsychiatric disorders such as Post-Traumatic Stress Disorder (PTSD). 

Dr Andrea Chicca, Co-Founder and Chief Executive Officer of Synendos, commented: "The transition to a clinical stage company marks a significant milestone and step forward for Synendos and for SYT-510, the first candidate in our new class of SERI molecules. More than a decade of research resulted in our identification of a completely new mechanism for treating complex neuropsychiatric conditions, and this has already demonstrated very promising pre-clinical results. With no new treatments available in this area for over 25 years, advances are desperately needed.  By addressing this unmet need with our novel technology, we have the potential to offer those struggling with anxiety, mood and stress-related disorders a differentiated, safe and effective way to alleviate symptoms through the holistic rebalancing of brain physiology."

Notes to Editors:

About Synendos Therapeutics AG
Synendos Therapeutics AG (Synendos) is a biopharmaceutical company developing first-in-class therapies to restore the healthy balance of brain physiology and meet the growing need for holistic and safe treatments for neuropsychiatric, neuroinflammatory and other Central Nervous System (CNS) disorders. A world leader in innovative Endocannabinoid System (ECS) treatments, Synendos is developing a new class of small molecules ? selective endocannabinoid reuptake inhibitors (SERIs) ? aimed at restoring the natural functioning of the ECS in the brain with the potential for treating a wide range of CNS disorders. Spun out of the University of Bern and incorporated in April 2019, the Company's novel technology stems from more than 10 years of solid research on endocannabinoid biology and pharmacology carried out by co-founders, Professor Jürg Gertsch and Dr. Andrea Chicca. For more information, please visit www.synendos.com.

About SERIs
Selective Endocannabinoid Reuptake Inhibitors (SERIs) are first-in-class endocannabinoid system modulators that mildly and selectively increase endogenous cannabinoids 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 CNS disorders associated with anxiety, mood and stress-related conditions.

SOURCE Synendos Therapeutics