Synendos Therapeutics AG Granted EMA Clinical Trial Authorisation

Synendos Therapeutics AG, a world leader in innovative Endocannabinoid System (ECS) treatments, has announced 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 randomised, double-blind, placebo-controlled study will investigate the safety, tolerability and pharmacokinetics of single-ascending doses of SYT-510 in healthy adult participants.

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.”

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). 


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