ReST Therapeutics Announces U.S. FDA Acceptance of Investigational New Drug (IND) Application for RST-101 for the Early Treatment of Post-Traumatic Stress Disorder (PTSD)
IND Acceptance Enables Initiation of First-in-Human Clinical Trial for Novel Early Intervention Approach to PTSD
ReST Therapeutics, a clinical-stage biopharmaceutical company focused on developing novel therapeutics for stress and trauma-related disorders through precision neuropsychiatry, today announced that the U.S. 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. "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," said Reina Benabou, MD, PhD, ReST Therapeutics Chief Medical Officer.
