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Synendos receives EMA nod for brain therapy

Company is focused on endocannabinoid system treatments.

Synendos Therapeutics – a company focused on innovative endocannabinoid system (ECS) treatments – has announced that it has received approval from the European Medicines Agency (EMA) to begin a phase 1 study of its SYT-510 asset.

The therapy is a first-in-class inhibitor that modulates a newly identified drug target in the endocannabinoid system to restore healthy brain physiology. The ECS is a key neuromodulator system, which plays a vital role in how the body responds to stress.

The double-blind, randomised, placebo-controlled trial will investigate the tolerability, safety and pharmacokinetics of single-ascending doses of the treatment among healthy adult participants.

Meanwhile, the company is developing selective endocannabinoid reuptake inhibitors (SERIs) that influence the balance of the ECS.

By restoring endogenous cannabinoid levels that are dysregulated in certain pathological conditions, the mode of action can potentially rebalance brain function in a pro-homeostatic way that could treat neuropsychiatric disorders such as post-traumatic stress disorder.

Dr Andrea Chicca, Chief Executive Officer of Synendos, reflected: “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.

He added: “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.”