Aptinyx Prepares for FDA Meeting on Novel PTSD Treatment NYX-783
Key Insights
Aptinyx is scheduled to meet with the FDA on April 29, 2021, to discuss the development pathway for NYX-783, a novel oral NMDA receptor (search) modulator for post-traumatic stress disorder (search) treatment.
The drug candidate demonstrated clinically meaningful and significant improvement on the primary endpoint of CAPS-5 Arousal and Reactivity Score in a phase IIa study.
With over 8.5 million Americans affected by PTSD (search) and only two FDA-approved treatments available for more than 20 years, NYX-783 represents a potential breakthrough in addressing this significant unmet medical need.
Aptinyx Inc. (APTX) is scheduled to hold a meeting with the FDA on April 29, 2021, to discuss the future development path for its drug candidate NYX-783 for the treatment of post-traumatic stress disorder (search). The novel oral NMDA receptor (search) modulator has shown promising results in clinical trials, potentially offering a new therapeutic option for a condition affecting millions of Americans.
Phase IIa Trial Results Show Promise
NYX-783 has been successfully trialed in a phase IIa study in patients with post-traumatic stress disorder (search). According to the top-line results reported last October, NYX-783 demonstrated clinically meaningful and significant improvement on the primary endpoint of CAPS-5 Arousal and Reactivity Score. This scale evaluates symptoms of post-traumatic stress disorder (PTSD (search)) such as hypervigilance, exaggerated startle response, irritability and aggression, reckless or self-destructive behaviors, and concentration and sleep disturbances.
Addressing a Significant Unmet Medical Need
PTSD (search) is a mental condition that may occur in people who have experienced or witnessed a terrifying event such as a natural disaster, a serious accident, a terrorist act, and war/combat. More than 8.5 million Americans are affected by PTSD, representing a substantial patient population with limited treatment options.
Currently, Pfizer's Zoloft and GlaxoSmithKline's Paxil, both selective serotonin reuptake inhibitors (SSRIs), are the only FDA-approved drugs for the treatment of PTSD (search). These two drugs were approved more than 20 years ago, highlighting the significant gap in therapeutic innovation for this condition.
Broader Pipeline Development
While NYX-783 represents an important opportunity in PTSD (search) treatment, Aptinyx's most advanced product candidate is NYX-2925, currently under phase IIb studies in two chronic pain indications - fibromyalgia (search) and painful diabetic peripheral neuropathy (search) (DPN). In the U.S., about 1.5 million are affected by fibromyalgia and 7.5 million people have painful DPN.
The company's pipeline also includes NYX-458, a small molecule N-methyl D-aspartate (NMDA) receptor modulator, under phase II exploratory study in patients with cognitive impairment associated with Parkinson's disease (search) and dementia with Lewy bodies (search). Data from the NYX-458 study is expected in the second half of 2022.
Financial Position and Timeline
The company ended the year 2020 with cash of roughly $141 million, which is expected to provide operational runway into 2023. Data readout from the fibromyalgia (search) and painful DPN trials are expected by the first half of next year.
APTX has traded in a range of $2.21 to $6.47 in the last year, with the stock closing Wednesday's trading at $2.82, up 0.36%.