European Medicines Agency approves phase 1 study for endocannabinoid

A biopharma company has received approval from the European Medicines Agency to commence a phase 1 clinical trial of its selective endocannabinoid reuptake inhibitor, which aims to restore healthy brain physiology.

According to a release from Synendos Therapeutics, its lead candidate, SYT-510, will be tested in an upcoming randomized, double-blind, placebo-controlled study to investigate the safety, tolerability and pharmacokinetics of single-ascending doses in healthy adults.

The novel therapeutic’s target is the endocannabinoid system, a key neuromodulator in the central nervous system that governs how the body deals with and responds to stress. By rebalancing and restoring endogenous cannabinoid levels that are dysregulated, SYT-510 may be able to rebalance brain function and treat neuropsychiatric disorders such as PTSD, Synendos said in the release.

“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,” Synendos co-founder and CEO Andrea Chicca, PhD, said in the release. “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.”