ReST Therapeutics recently announced that the US Food and Drug Administration (FDA) has accepted the company's Investigational New Drug (IND) application for RST-101, its lead investigational therapeutic candidate for the early treatment of Post-Traumatic Stress Disorder (PTSD). The IND acceptance clears the way for ReST Therapeutics to initiate a first-in-human clinical trial evaluating RST-101 in healthy volunteers.

Reina Benabou, MD, PhD, Chief Medical Officer (CMO), ReST Therapeutics, said, "We are very pleased with the FDA acceptance of our IND application, which allow us to initiate the First-In-Human clinical trial to evaluate the safety, tolerability, pharmacokinetics and food effect characteristics of RST-101 in healthy volunteers, a pivotal step in our clinical development program to address early PTSD and potentially avoid debilitating long-term symptoms, a profound unmet medical need in mental health."

PTSD affects millions of people worldwide and is characterised by persistent psychological distress following exposure to traumatic events. Current treatment approaches typically begin a significant amount of time after trauma exposure, missing a critical early intervention window. RST-101 represents a paradigm shift in PTSD treatment by targeting the biological mechanisms of trauma response in the early phase following traumatic exposure, potentially preventing the development of chronic PTSD.

Gilles Rubinstenn, PhD, MBA, Founder and Chief Innovation Officer, said, “This is quite an achievement for ReST therapeutics and a tribute to the commitment of our team and partners. What started with a conviction that we could quench the consolidation of traumatic events into a chronic PTSD plaguing the life of millions of civilians and veterans now enters clinical phase.”