Biopharma company Aptinyx Inc. says its phase 2b clinical study evaluating the effects of NYX-2925 in patients with fibromyalgia did not achieve statistically significant separation from placebo on the study’s primary endpoint.
“We are very disappointed that, despite the evidence of activity observed in a prior biomarker study in fibromyalgia patients, in this follow-up phase 2b study NYX-2925 did not achieve statistical separation from placebo,” said Andy Kidd, president and chief executive officer of Aptinyx.
“We greatly appreciate the contributions made by patients, investigators, collaborators, and our dedicated Aptinyx team in the evaluation of NYX-2925’s utility in pain. The results of this study highlight the challenges of developing novel therapies for pain.
“As we continue to analyze the data from the study, we will focus our resources on supporting additional readouts from our pipeline in PTSD and cognitive impairment, including the readout of our Phase 2 study of NYX-458 in cognitive impairment associated with Parkinson’s disease, expected in the first quarter of next year.”
The fibromyalgia study was a randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of NYX-2925 in approximately 300 patients with fibromyalgia. Following a screening period, eligible patients were 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 was the change from baseline in average daily pain as reported on the zero-to-ten NRS during week 12 of the study.
Statistically significant separation from placebo was not observed on the primary endpoint of the study with either dose level of NYX-2925. Patients receiving NYX-2925 at both dose levels showed a trend toward clinically meaningful improvement in pain, as well as in some secondary endpoints, versus placebo by week 4.
However, by week 12, the placebo group had improved such that, although NYX-2925 remained numerically better, the separation was not clinically meaningful. Across both dose levels, NYX-2925 was well tolerated in the study, with no concerning safety issues observed. Detailed data from the study continue to be evaluated.