Aptinyx Inc. ( APTX Quick Quote APTX - Free Report) announced encouraging data from a phase II study evaluating its novel NMDA receptor modulator candidate, NYX-783, in patients with post-traumatic stress disorder (“PTSD”). Data showed clinically meaningful effect along with excellent tolerability, boosting its prospect as a promising therapeutic candidate for PTSD, one of the most complex and difficult-to-treat psychiatric conditions. Based on these promising data from the mid-stage study, the company plans to initiate a pivotal study in 2021.
Shares of Aptinyx surged more than 85% in after-market trading on Oct 19, following the study data readout. The company’s shares have increased 7% so far this year against the
industry’s decrease of 0.2%.
The company was evaluating two doses of NYX-783 — 10mg or 50 mg — in phase II exploratory study in two, four-week sequential stages with no patients receiving more than four weeks of NYX-783 treatment. The primary endpoint of the study was to achieve improvement on the Clinician-Administered PTSD Scale, CAPS-5 total score, and symptom domain sub-scores.
Data from the study showed that treatment with either dose of NYX-783 achieved clinically meaningful and statistically significant improvement in CAPS-5 total score compared to placebo. However, the higher dose of the candidate demonstrated more consistent effects than the lower dose.
Clinically meaningful improvement was observed within just four weeks in the 50 mg dose arm. A total of 78% of patients achieved a 30% improvement from baseline in the CAPS-5 total score versus 44% of patients in the placebo arm. Moreover, 50% of patients administered a 50mg dose of NYX-783 achieved a 50% CAPS-5 total score improvement from baseline compared to 26% of patients receiving placebo.
Please note that NYX-783 enjoys Fast Track designation in the United States for treating PTSD.
We note that the complexity of the PTSD makes it difficult to treat with very few treatment options available including
Glaxo’s ( GSK Quick Quote GSK - Free Report) Paxil and Pfizer’s ( PFE Quick Quote PFE - Free Report) Zoloft. This represents a significant opportunity for NYX-783 following a potential approval.
Apart from NYX-783, Aptinyx is also developing two other NMDA receptor-targeted candidates — NYX-2925 and NYX-458 — in mid-stage studies. NYX-2925 is being developed for treating chronic pain indications including fibromyalgia and painful diabetic peripheral neuropathy. The company is evaluating NYX-458 as a potential treatment for Parkinson’s disease and cognitive impairment.
We remind investors that there are several companies, including
J&J ( JNJ Quick Quote JNJ - Free Report) , Eli Lilly, and Roche developing NMDA receptor-targeted candidates, which will likely provide competition to Aptinyx’s pipeline going forward. Zacks Rank
Aptinyx currently carries a Zacks Rank #3 (Hold). You can see
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