Aptinyx's lead drug makes cut in small fibromyalgia trial, setting the stage for larger chronic pain study
Four months ago, its lead drug fell short of hitting statistical significance in a diabetic peripheral neuropathy (DPN) study. On Monday, the newly-public Aptinyx revealed the experimental treatment has scored in a small mid-stage fibromyalgia trial, paving the way for a larger study to begin in the second half of this year.
The drug — dubbed NYX-2925 — was developed by the Evanston, IL-based biotech $APTX that went public last July banking on its approach to modulate NMDA receptors, which are crucial to brain and nervous system function.
Fibromyalgia patients suffer widespread musculoskeletal pain accompanied by fatigue, sleep, memory and mood issues — and researchers suspect that the disorder amplifies painful sensations by affecting the way the brain processes pain signals. Fibromyalgia is also considered to be associated with increased overall levels of glutamate/glutamine (Glx) in certain brain regions, which is understood to correspond with enhanced pain severity.
NYX-2925 was tested in a 23-patient single-blind study. In a sequential manner, but blinded to the patient, all patients received daily doses of placebo, 20 mg dose of the drug and 200 mg NYX-2925 for two weeks each. Over the course of the trial, patients were tested for key brain activity and neurochemistry biomarkers known to be associated with perception and processing of centralized chronic pain.
Compared to placebo, administration of NYX-2925 resulted in statistically significant reductions of Glx levels in these key pain-regulating brain regions, and the use of the drug also resulted in reduced connectivity between brain regions that are known to be associated with the processing of centralized chronic pain, Aptinyx said, adding that the patient-reported secondary endpoints were also met.
“The results with NYX-2925…compare very favorably with the effects of approved fibromyalgia drug treatments we previously evaluated in separate and similar studies,” said Daniel Clauw, professor of medicine at the University of Michigan and an investigator in the study. “(I)t is notable that, despite the small number of patients in the study, the effects on these clinical assessments of pain and other symptoms were also statistically significant.”
Even though the DPN study did not meet its primary endpoint, the company claims certain doses of the drug did confer a numerical improvement. Aptinyx says it plans to begin follow-up studies in DPN and fibromyalgia later this year.