Synendos Therapeutics AG Secures EMA Approval for Clinical Trials of Pioneering Endocannabinoid System Modulator, SYT-510
Friday, January 19, 2024
Synendos Therapeutics AG, a leader in innovative Endocannabinoid System (ECS) treatments, has received approval from the European Medicines Agency (EMA) to initiate the Phase 1 clinical trial for its lead compound, SYT-510. This first-in-class inhibitor modulates a newly identified drug target within the ECS to restore healthy brain physiology.
The Phase 1 trial, employing a randomized, double-blind, placebo-controlled design, will assess the safety, tolerability, and pharmacokinetics of single-ascending doses of SYT-510 in healthy adult participants.
Synendos focuses on developing selective endocannabinoid reuptake inhibitors (SERIs) that influence ECS balance through a novel mechanism. The ECS, a key neuromodulator system in the central nervous system (CNS), plays a significant role in the body's stress response. The innovative approach of rebalancing and restoring dysregulated endogenous cannabinoid levels holds potential for a holistic restoration of brain function, especially in addressing neuropsychiatric disorders like Post-Traumatic Stress Disorder (PTSD).
Dr. Andrea Chicca, Co-Founder and CEO of Synendos, highlighted the significance of this milestone, marking the company's transition to a clinical stage entity. SYT-510, the first candidate in their new class of SERI molecules, is the result of over a decade of research, uncovering a completely new mechanism for treating complex neuropsychiatric conditions. The pre-clinical results have been promising, and with no new treatments in this domain for over 25 years, there is a pressing need for advancements. Synendos aims to address this gap with their novel technology, offering a differentiated, safe, and effective approach to alleviate symptoms of anxiety, mood disorders, and stress-related conditions by holistically rebalancing brain physiology.
Source: prnewswire.com
