NYX-2925 did not achieve statistically significant separation from placebo on primary endpoint
Meaningful improvements on pain and other endpoints observed in subjects receiving 50 mg dose and in subjects not taking a concomitant analgesic medication
NYX-2925 was well-tolerated with no significant adverse events
Further analysis of full dataset to guide potential next steps in development for chronic pain
In the randomized, double-blind, placebo-controlled study, 300 subjects with painful DPN received daily oral doses of placebo or NYX-2925 at 10 mg, 50 mg, or 200 mg over the course of four weeks. Subjects were randomized in a 1:1:1:1 ratio. Baseline values for each endpoint were measured over the seven-day period prior to randomization. All subjects in the study had moderate to severe pain at baseline. The primary endpoint of the study was the mean change in average daily pain, as measured using the NRS (on which 0 represents no pain and 10 represents worst pain imaginable), at week four of treatment compared to baseline. Key secondary endpoints in the study included worst daily pain, pain on walking, and sleep interference.
In the study, the 50 mg and 200 mg dose levels of NYX-2925 showed the greatest improvements from baseline, with the 50 mg dose showing numerical superiority. The group treated with 50 mg of NYX-2925 showed a 1.61-point reduction from baseline in average daily pain on the NRS, the largest such reduction among the dose levels evaluated. This improvement did not separate statistically (p=0.1586) from the 1.23-point reduction observed in the placebo group. No plateau in the effect of NYX-2925 at 50 mg was observed by the end of this four-week study, suggesting a longer treatment duration may result in a stronger analgesic effect. Subjects receiving NYX-2925 at 50 mg also had clinically meaningful trends of improvement on key secondary endpoints, including sleep and pain on walking.
In a pre-specified subset of subjects who were not taking a concomitant medication, those treated with NYX-2925 across all dose levels showed improvements relative to placebo on pain and other endpoints that were greater than those observed in the overall study population.
“This four-week proof-of-concept study of our novel NMDA receptor modulator, NYX-2925, in painful DPN was designed to evaluate a 20-fold dose range, determine whether efficacy and dose response could be observed on primary and secondary endpoints, and assess safety in a patient population,” said
“We are in the midst of a major societal and healthcare crisis in the treatment of pain and many patients currently lack therapeutic options that do not have significant side effects or abuse potential,” said
NYX-2925 is also currently in an exploratory Phase 2 study in subjects with fibromyalgia. An interim analysis of this study yielded promising evidence of activity on both objective and subjective measures.
About Neuropathic Pain
Neuropathic pain associated with various conditions affects an estimated 7% to 9% of the U.S. population. Individuals suffering from this condition, across the underlying disorders, are currently treated with a variety of therapies including antidepressants, anticonvulsants, and opioids. These medications offer inadequate efficacy for a large proportion of patients, are often poorly tolerated due to side effects, and in some cases are associated with abuse.
NYX-2925 is a novel NMDA receptor modulator currently in Phase 2 clinical development and also under evaluation in an exploratory Phase 2 study in fibromyalgia. NYX-2925 has demonstrated robust activity in preclinical models of numerous neuropathic pain conditions with a favorable tolerability profile. In a Phase 1 clinical study in healthy human subjects, NYX-2925 was well tolerated across a wide dose range, including dose levels well in excess of the expected therapeutic levels.
Aptinyx Inc. is a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of proprietary synthetic small molecules for the treatment of brain and nervous system disorders. Aptinyx has a platform for discovery of novel compounds that work 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 company has three product candidates in clinical development in central nervous system indications, including chronic pain, post-traumatic stress disorder, and cognitive impairment associated with Parkinson’s disease. Aptinyx is also advancing additional compounds from its proprietary discovery platform, which continues to generate a rich and diverse pipeline of small-molecule NMDA receptor modulators with the potential to treat an array of neurologic disorders. For more information, visit www.aptinyx.com.
Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding the company’s business plans and objectives, including future plans or expectations for NYX-2925, therapeutic effects of the company’s product candidates, expectations regarding the design, implementation, timing, and success of its current and planned clinical trials, expectations regarding its preclinical development activities, and expectations regarding its uses and sufficiency of capital. Risks that contribute to the uncertain nature of the forward-looking statements include: the success, cost, and timing of the company’s product candidate development activities and planned clinical trials; the company’s ability to execute on its strategy; positive results from a clinical study may not necessarily be predictive of the results of future or ongoing clinical studies; regulatory developments in
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Source: Aptinyx Inc.