Aptinyx announced results from an interim analysis of an exploratory study of its novel NMDA receptor modulator, NYX-2925, in subjects with fibromyalgia. Subjects in the study receive daily oral doses of NYX-2925 at two dose levels, 20 mg and 200 mg, as well as placebo, over the course of six weeks. The interim analysis was conducted on data from the first 11 subjects who have completed the study. Administration of NYX-2925 resulted in statistically significant effects on the primary endpoint, changes in markers of central pain processing as measured by advanced imaging techniques, including changes in combined glutamate and glutamine levels in brain regions that were pre-specified and selected for analysis based on their known involvement in processing pain. Improvement trends were also observed on multiple secondary endpoints, including patient-reported pain scores, as measured by the Numeric Pain Rating Scale, and the Revised Fibromyalgia Impact Questionnaire. NYX-2925 was well tolerated with no subjects reporting treatment-related serious adverse events. Based on these positive interim data, Aptinyx expects to initiate a larger Phase 2 study of NYX-2925 in subjects with fibromyalgia in 2019. The study is ongoing with the full data expected to read out in the first half of 2019. Once completed, the company plans to submit the detailed results from this study for publication and presentation at future scientific and medical meetings.
No comments:
Post a Comment
Note: Only a member of this blog may post a comment.