As learning processes are involved in fear extinction, NYX-783’s mechanism of enhancing synaptic plasticity and facilitating learning is highly relevant. “One of the hallmarks of PTSD is an inability to appreciate that stimuli associated with traumatic events no longer constitute a threat. “With this Fast Track designation, the FDA recognizes the potential of NYX-783 to help patients with PTSD, who are significantly under-served by the treatment options available today,” said Torsten Madsen, M.D., Ph.D., chief medical officer of Aptinyx. The study will include both single ascending dose and multiple ascending dose cohorts, each with placebo controls. The randomized, double-blind, placebo-controlled Phase 1 study will enroll approximately 64 healthy volunteers to evaluate the safety and tolerability of NYX-783 at multiple dose levels using a once-per-day capsule formulation. Aptinyx has initiated a Phase 1 clinical study to evaluate the safety and tolerability of NYX-783 in healthy volunteers and plans to advance the compound into studies to evaluate efficacy next year. The FDA’s Fast Track program was implemented to expedite the development and regulatory review of therapeutic programs that seek to address significant unmet medical needs. Food and Drug Administration has granted Aptinyx Fast Track designation for the development of NYX-783 for the treatment of PTSD. The data were presented at the annual meeting of the American College of Neuropsychopharmacology (ACNP). Data Presented at American College of Neuropsychopharmacology Annual Meeting Demonstrate Robust and Durable Response in Models Relevant to PTSDĮvanston, Ill., – Aptinyx Inc., a clinical-stage biopharmaceutical company developing transformative therapies for challenging neurologic disorders, today announced Fast Track designation, new data, and initiation of Phase 1 clinical development for its second clinical candidate to modulate N-methyl-D-aspartate (NMDA) receptors, NYX-783, in post-traumatic stress disorder (PTSD).

Fasttrack schedule 2017