Pandemic Prompts Pause of Patient Enrollment in Fibromyalgia Trial of NYK-2925

Pandemic Prompts Pause of Patient Enrollment in Fibromyalgia Trial of NYK-2925

In response to the COVID-19 pandemic, Aptinyx has temporarily suspended enrollment in its ongoing Phase 2b clinical trial investigating NYX-2925 in women with fibromyalgia.

The company, however, has taken measures to make sure that current participants continue receiving the daily treatment.

The decision to pause enrollment and continue treatment of previously included patients extends to most of the company’s ongoing trials. Only a Phase 2 trial (NCT04044664) of NYX-783 in post-traumatic stress disorder,  which will follow-up patients online, will continue enrolling — as long as it is responsible and practical — the company said in a press release.

“Like other life sciences companies, we have had to assess the impact of the evolving COVID-19 pandemic on the enrollment and conduct of our ongoing Phase 2 studies. The health and safety of the patients, clinicians, and colleagues involved in our studies are of the utmost importance to Aptinyx,” said Norbert Riedel, PhD, president and CEO of Aptinyx.

“Under these unprecedented circumstances, we are taking actions to address and react to operational challenges and reduce the risk of viral infection,” Riedel said.

NYX-2925 is an oral analgesic designed to alleviate chronic pain in a variety of conditions. It does so by modulating the activity of the NMDA receptor, whose excessive activation causes nerve cells in the spinal cord to become overly sensitive to stimuli.

The therapy changes how neurons communicate with one another, ultimately affecting the processing of pain in the brain and spinal cord. This lessens pain and other associated symptoms.

NYX-2925 has shown effectiveness across different preclinical models of neurophatic pain, and was safe and well-tolerated across a wide range of doses in healthy individuals taking part in a Phase 1 trial (NCT02834741).

A later Phase 2 trial (NCT03249103) tested NYX-2925 in women with fibromyalgia, all of whom first received a placebo for two weeks, followed by a once-daily 20 mg dose of NYX-2925 for a similar period. They then received a higher dose (200 mg) for two more weeks.

Results showed that the lower dose of NYX-2925 was enough to affect neuroimaging biomarkers, which was associated with reduced pain sensitivity. It also decreased nerve cell communication across brain areas known to be associated with the processing of chronic pain. The 200 mg dose also significantly lessened pain and fatigue.

The ongoing double-blind Phase 2b trial (NCT04147858) is assessing the safety and effectiveness of NYX-2925 across a larger group of fibromyalgia patients. About 300 participants were expected to enroll at 25 U.S. locations.

After a one- to four-week screening period during which participants stop using their analgesic medications, they are randomly assigned to receive either NYX-2925 (50 mg or 100 mg) or a placebo once daily for 14 weeks. All women will receive placebo at some point during the treatment period.

The primary goal is to measure changes in daily pain for a period of 12 weeks.

Top-line data from the trial was expected by February 2021, but the temporary pause in patient recruitment likely will affect this timing. The company is planning to update the estimated completion date after enrollment is resumed.