Synendos Therapeutics Bags EMA Nod To Begin Phase 1 Trial of Endocannabinoid

The European Medicines Agency (EMA) has approved Synendos Therapeutics AG (Synendos), a global leader in cutting-edge Endocannabinoid System (ECS) treatments, to begin the phase 1 "first-in-human" clinical trial of its lead asset, SYT-510, a first-in-class inhibitor that modulates a recently discovered 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, as per pharmabiz.

Selective endocannabinoid reuptake inhibitors (SERIs), which have an innovative mode of action, are being developed by Synendos. One important CNS neuromodulator system that affects how the body reacts to stress is the ECS. This new mode of action has the potential to treat neuropsychiatric disorders like Post-Traumatic Stress Disorder (PTSD) by rebalancing and restoring endogenous cannabinoid levels, which are dysregulated in certain pathological conditions. This approach would rebalance brain function in a holistic and pro-homeostatic way.

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."