Aptinyx Shares Trade 17% Higher on Positive Top-Line Data in Phase 2 PTSD Trial

Source: Streetwise Reports   10/20/2020

Aptinyx shares set a new 52-week high price after the company reported statistically significant, top-line data from its Phase 2 Study of NYX-783 in patients diagnosed with post-traumatic stress disorder.

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%).

Disclosure:
1) Stephen Hytha compiled this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor. He or members of his household own securities of the following companies mentioned in the article: None. He or members of his household are paid by the following companies mentioned in this article: None.
2) The following companies mentioned in this article are billboard sponsors of Streetwise Reports: None. Click here for important disclosures about sponsor fees.
3) Comments and opinions expressed are those of the specific experts and not of Streetwise Reports or its officers. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security.
4) The article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility. By opening this page, each reader accepts and agrees to Streetwise Reports’ terms of use and full legal disclaimer. This article is not a solicitation for investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company mentioned on Streetwise Reports.
5) From time to time, Streetwise Reports LLC and its directors, officers, employees or members of their families, as well as persons interviewed for articles and interviews on the site, may have a long or short position in securities mentioned. Directors, officers, employees or members of their immediate families are prohibited from making purchases and/or sales of those securities in the open market or otherwise from the time of the decision to publish an article until three business days after the publication of the article. The foregoing prohibition does not apply to articles that in substance only restate previously published company releases.
6) This article does not constitute medical advice. Officers, employees and contributors to Streetwise Reports are not licensed medical professionals. Readers should always contact their healthcare professionals for medical advice.