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PTSD Drug Trial Begins, Gets Fast-Track Status

Brain circuits illustration

(HypnoArt, Pixabay)

7 December 2017. An experimental drug that aims to keep nerve cells flexible is beginning an early-stage clinical trial as a treatment for post-traumatic stress disorder, or PTSD. The drug code-named NYX-783 is made by biotechnology company Aptinyx Inc. in Evanston, Illinois, which also received a fast-track designation from the U.S. Food and Drug Administration.

Aptinyx develops treatments for neurological disorders that result from the lack of plasticity in synapses, the part of neurons, or nerve cells, that pass signals with neurotransmitter chemicals in the brain and nervous system. The company’s technology focuses on a particular set of pathways known as N-Methyl-D-aspartate, or NMDA, receptor molecules found in synapses. NMDA receptors help keep synapses flexible, which affects memory, learning, and development of the central nervous system. Aptinyx expects to use this platform to discover small-molecule, or low molecular weight drugs to treat PTSD and other disorders such as depression, neuropathic pain, migraine, and epilepsy.

The company says NYX-783 is designed to enhance the plasticity of synapses as a way to improve learning processes, considered a key factor in overcoming fear, and thus help relieve PTSD. People who experience or witness a terrifying event can experience nightmares or flashbacks for periods of time after the event, which can subside with counseling or help from family and friends.

For some people, however, the reminders continue and can develop into PTSD, marked by anxiety or depression, often with debilitating effects on their families, jobs, and personal relationships. Anxiety and Depression Association of America says some 7.7 million Americans age 18 and older have PTSD, including two-thirds of people experiencing mass violence, such as members of the military.

Aptinyx says in preclinical tests NYX-783 shows strong and long-lasting effects in enhancing plasticity of nerve cells, with favorable results in indicators of depression, learning, and fear extinction. The clinical trial is expected to test the safety and tolerability of NYX-783 among 64 healthy volunteers. The drug will be given as a daily capsule, with dosage levels evaluated against a placebo.

The company says FDA also assigned NYX-783 fast-track status, which qualifies Aptinyx for more frequent meetings and written communications with the agency as NYX-783 is reviewed. FDA designates drugs for fast-track reviews if they show superior effectiveness against serious disorders, or address emerging or anticipated public health needs. Aptinyx says preclinical data on NYX-783 reported at last month’s Society for Neuroscience meeting supported its request for fast-track status.

Aptinyx was formed in September 2015, when Naurex Inc., a spin-off enterprise from Northwestern University, was acquired by drug maker Allergan, which did not wish to continue Naurex’s work on drugs addressing NMDA receptors. Joseph Moskal, a biomedical engineering professor at Northwestern who founded Naurex, chose to stay with Aptinyx to continue development of NMDA receptor drugs. As reported by Science & Enterprise in May 2016, Aptinyx raised $65 million in its first venture funding round.

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