New Phase 2 Trial to Test NYX-2925 as Potential Fibromyalgia Therapy

New Phase 2 Trial to Test NYX-2925 as Potential Fibromyalgia Therapy

A new Phase 2 clinical trial will continue to assess the safety and effectiveness of the non-opioid small molecule candidate therapy NYX-2925, developed by Aptinyx, in fibromyalgia patients.

NYX-2925 is an oral therapy that modulates the NMDA receptor, which is key in neuronal communication and is involved in regulating pain signals in the brain and spinal cord. NYX-2925 alters neural cell communication, and is seen as a potential therapy to lessen pain and other symptoms associated with chronic pain.

In preclinical models of different neuropathic pain conditions, NYX-2925 showed robust effectiveness, and a favorable safety profile. Data from a subsequent Phase 1 trial (NCT02834741) with healthy individuals, showed NYX-2925 was well-tolerated across a wide range of doses.

A previous Phase 2 trial (NCT03249103) that tested daily oral treatment with 20 mg and 200 mg of NYX-2925, as well as a placebo, over six weeks. Results  showed that NYX-2925 blocked pain hypersensitivity, and significantly changed neuroimaging biomarkers, fatigue, and overall function in people with fibromyalgia.

“The data from the two prior Phase 2 studies with NYX-2925 are very compelling and I am excited to be working with Aptinyx on these next studies as they seek to advance this novel mechanism for chronic pain patients,” Lesley Arnold, MD, an investigator in the study, said in a press release. Arnold is a professor of psychiatry and behavioral neuroscience at the University of Cincinnati, Ohio.

The safety and effectiveness of NYX-2925 in fibromyalgia now will be assessed in a randomized, double-blind, placebo-controlled Phase 2 trial (NCT04147858). The study, seeking to enroll approximately 300 patients, will take place at 25 U.S. locations. Recruitment is not yet open, but  information about enrollment should be updated here.

Participants will be randomized to receive either 50 mg or 100 mg of NYX-2925, or a placebo once daily for 14 weeks, after a one- to four-week screening period.

The study’s primary outcome is to establish the change in average daily pain score, as measured using the 10-point Numeric Rating Scale (in which 0 indicates no pain, and 10 indicates the worst pain imaginable). Secondary outcomes include changes in pain, fatigue, cognitive performance and quality of life.

Another Phase 2 trial will assess the safety and effectiveness of  the potential therapy in people with painful diabetic peripheral neuropathy (DPN).

Top-line results are expected in the first half of 2021.

“These study initiations represent an important milestone in the development of NYX-2925 for chronic centralized pain conditions,” said Norbert Riedel, PhD, president and CEO of Aptinyx.

“We are eager to advance NYX-2925 in development as a novel, non-opioid therapeutic option for patients who are vastly underserved by the treatments available today. Our prior clinical data on NYX-2925 give us great confidence in its potential to fill a substantial void in the treatment paradigm,” Riedel said.