1 March 2022 - - US-based biopharmaceutical company Aptinyx Inc. (NASDAQ: APTX) has completed enrollment of 305 patients in the company's ongoing Phase 2b study of NYX-2925 in fibromyalgia, the company said.

Patients recently enrolled in the study are completing the 12-week treatment period and 30-day safety follow-up period.

The company expects to report results from the study in early to mid 3Q 2022.

The Phase 2b study is evaluating the efficacy and safety of NYX-2925 in patients with fibromyalgia. The primary endpoint is the change from baseline to week 12 in average daily pain scores as reported on the 10-point numeric rating scale.

Key secondary endpoints evaluate fatigue, cognitive performance, and patient quality of life.

The Phase 2 study is a randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of NYX-2925 in 305 patients with fibromyalgia.

Following a screening period, eligible patients are randomized to receive oral doses of NYX-2925 50 mg, NYX-2925 100 mg, or placebo once daily over the treatment period.

The primary endpoint in the study is the change from baseline to week 12 in average daily pain scores as reported on the 10-point numeric rating scale.

Multiple secondary endpoints related to pain, fatigue, cognitive performance, and patient quality of life are also evaluated.

NYX-2925 is a novel oral NMDA receptor positive allosteric modulator currently in Phase 2 clinical development for the treatment of chronic pain.

In clinical studies, NYX-2925 has demonstrated activity that affects central pain processing, resulting in alleviation of pain and other symptoms associated with chronic pain conditions.

NYX-2925 has also exhibited a favorable safety and tolerability profile across a wide dose range in clinical studies to date.

The US Food and Drug Administration has granted Fast Track designation to Aptinyx's development of NYX-2925 for the treatment of neuropathic pain associated with DPN.

Fibromyalgia is a chronic condition associated with widespread pain and tenderness, as well as general fatigue.

Fibromyalgia is considered by many to be a condition that is largely mediated in the central nervous system, given that fibromyalgia sufferers often present without a direct peripheral insult or injury.

People suffering from fibromyalgia also often experience sleep disruption, depressed mood, and cognitive impairment. It is estimated that, in the United States, fibromyalgia affects more than 8m people.

Currently, there are only three FDA-approved pharmacologic treatments for fibromyalgia, but they have limited efficacy and burdensome side effects in many patients.

Aptinyx 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.

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.