The biopharmaceutical company Aptinyx recently announced updates regarding its two Phase 2 clinical trials evaluating the company’s lead therapy candidate, NYX-2925. This therapy aims to treat pain associated with fibromyalgia and neuropathic pain associated with diabetic peripheral neuropathy (DPN).
NYX-2925 is a modulator of the N-methyl-D-aspartate (NMDA) receptor, which is involved in the process that causes chronic pain. The investigational therapy binds to a distinct, recently discovered site on the NMDA receptor to modulate NMDA-receptor-channel opening and enhance synaptic plasticity. This unique method was shown to be effective in animal models of several pain conditions and had a favorable safety profile.
In a previous Phase 1 clinical study (NCT02834741) in healthy subjects, NYX-2925 was found to be well-tolerated across a wide dose range.
“The Phase 1 study clearly demonstrated that NYX-2925 has highly predictable pharmacokinetics and is well-tolerated at doses that far exceed anticipated therapeutic doses. Therefore, we have advanced NYX-2925 into Phase 2 development for neuropathic pain associated with diabetic peripheral neuropathy, a condition in which patients struggle to manage their pain effectively with currently available therapeutic options,” Torsten Madsen, MD, PhD, Aptinyx’s chief medical officer, said in a press release.
“Our preclinical research also supports studying NYX- 2925 in several other chronic pain conditions, including fibromyalgia,” Madsen added.
Researchers will soon start recruiting patients for the Phase 2 study (NCT03249103) in patients with fibromyalgia. That trial is expected to enroll about 24 participants. The study is designed to determine whether once-daily dosing of NYX-2925 over a two-week period will induce a change in markers of central pain processing, as assessed by neuroimaging.
The trial also will provide the first safety profile of NYX-2925 for fibromyalgia patients and includes exploratory endpoints to understand the effects of two oral doses on several pain, fatigue, cognition, and sleep parameters.
The second Phase 2 trial (NCT03219320) is enrolling patients to evaluate NYX-2925 as a treatment for neuropathic pain associated with DPN. This trial will enroll approximately 300 patients with type 2 diabetes who will receive oral doses of either NYX-2925 or a placebo once daily for four weeks.
The study’s primary endpoint is to measure the therapeutic effectiveness in neuropathic pain of NYX-2925 versus a placebo at any dose level. Secondary endpoints include assessing the effects of NYX-2925 on pain characteristics, sleep patterns, and psychological state, as well as its safety and tolerability.
In September 2016, the U.S. Food and Drug Administration (FDA) granted fast track designation to Aptinyx’s NYX-2925 for development as a treatment for neuropathic pain associated with DPN.
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