Aptinyx's Chronic Pain Candidate Fails To Top Placebo In Mid-Stage Study

  • Aptinyx Inc APTX has announced results from a Phase 2b study evaluating the effects of NYX-2925 in patients with fibromyalgia, characterized by muscular or musculoskeletal pain with stiffness and localized tenderness at specific points.
  • NYX-2925 did not achieve statistically significant separation from placebo on the study's primary endpoint of change in average daily pain.
  • "We are very disappointed that, despite the evidence of activity observed in a prior biomarker study in fibromyalgia patients," said Andy Kidd, president & CEO.
  • Related: Aptinyx Shares Tank On Disappointed Data From Mid-Stage Diabetic Peripheral Neuropathy Study.
  • The company continues to analyze the data from the study. It will focus the resources on supporting the readout of the Phase 2 study of NYX-458 in cognitive impairment associated with Parkinson's disease, expected in Q1 of 2023.
  • Patients receiving NYX-2925 at both dose levels showed a trend toward clinically meaningful improvement in pain and 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. 
  • Price Action: APTX shares are down 33.30% at $0.40 on the last check Friday.
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