Aptinyx Inc. (APTX:NASDAQ), which is focused on the development of therapies for treating brain and nervous system disorders, yesterday announced "positive results from the first Phase 2 study of its novel NMDA receptor modulator, NYX-783, in 153 patients with post-traumatic stress disorder (PTSD)."
The firm stated that NYX-783 demonstrated statistically significant and clinically meaningful efficacy results in the Phase 2 trial. Aptinyx advised that based upon the positive results observed in the study it anticipates that it will proceed with a pivotal study in 2021.
Murray Stein, M.D., MPH, FRCPC, Distinguished Professor of Psychiatry and Public Health and Vice Chair for Clinical Research in Psychiatry at the University of California, San Diego and a consultant to Aptinyx, remarked, "Post-traumatic stress disorder is one of the most complex and difficult-to-treat psychiatric conditions due to a host of debilitating symptoms...It is encouraging to see such positive effects with NYX-783 in this study, especially given the relatively short duration of treatment. Although few drugs have shown efficacy in PTSD, this study of NYX-783 has demonstrated preliminary evidence of clinically meaningful effect along with excellent tolerability."
The company noted that the primary objective of the study was achieved as both once-daily 10 mg and 50 mg dosage levels produced clinically meaningful and statistically significant improvement on the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Arousal and Reactivity Score. The firm advised that the CAPS-5 indicator is used to evaluate PTSD symptoms including concentration and sleep disturbances, exaggerated startle response, hypervigilance, irritability and aggression and reckless or self-destructive behaviors.
The firm stated NYX-783 was well tolerated and exhibited a favorable adverse event profile and that it registered improvements in both primary and multiple secondary and exploratory endpoints in the trial. The company advised that "across endpoints in the study, a clear dose response was evident with the 50 mg dose demonstrating more consistent effects than the 10 mg dose."
The company's President and CEO Norbert Riedel, Ph.D., commented, "We are very pleased with these impressive results, which surpassed our expectations for this initial exploratory study and clearly indicate the strong potential of NYX-783 to rapidly and reliably address some of the most challenging symptoms of PTSD...People suffering from PTSD have immense unmet medical needs and the few existing therapeutic options offer limited benefit. We believe these results indicate that the mechanism of NYX-783, which modulates NMDA receptors to enhance extinction learning, addresses the putative underlying pathology of PTSD. We expect the data from this study will support discussion with the FDA and the initiation of a first pivotal study."
The company explained that the Phase 2 Exploratory Study of NYX-783 in PTSD was a multi-center, double-blind, placebo-controlled, randomized study of 153 patients diagnosed with PTSD. The study was structured by deign such that no patient in the study would receive the NYX-783 treatment for greater than four weeks.
The company noted that 8.5 million people in the U.S. suffer from PTSD. The firm advised that the condition is typically characterized by intrusive symptoms including arousal alterations, avoidance, hyperarousal and negative changes in cognition and mood subsequent to experiencing trauma. PTSD often results from numerous forms of trauma, including abuse, car accidents, combat exposure, physical or sexual assault and natural disaster events. The company stated that the highest prevalence of the disorder is demonstrated in military service members and first responders due to the nature and dangers surrounding those professions.
The company identified NYX-783 as "a novel, oral NMDA receptor modulator currently in Phase 2 development for the treatment of post-traumatic stress disorder (PTSD)." The firm indicated that NYX-783 has been granted Fast Track designation by the U.S. Food and Drug Administration for the treatment of PTSD.
Aptinyx, a clinical-stage biopharmaceutical firm headquartered in Evanston, Ill., stated that its "platform for discovery of novel compounds works through a unique mechanism to modulate—rather than block or over-activate—NMDA receptors and enhance synaptic plasticity, the foundation of neural cell communication." The firm advised that it presently has product candidates being evaluated in clinical studies for use in the treating central nervous system indications in the areas of chronic pain, cognitive impairment associated with Parkinson's disease and PTSD.
Aptinyx began the day with a market capitalization of around $171.90 million with approximately 46.96 million shares outstanding and a short interest of about 2.2%. APTX shares opened more than 60% higher today at $5.95 (+$2.29, +62.57%) over yesterday's $3.66 closing price and reached a new 52-week high price this morning of $6.47. The stock traded today between $4.23 and $6.47 per share and closed at $4.30 (+$0.64, +17.35%).[NLINSERT]
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