Biogen Reports Mixed Phase 2 Data For Its Non-Opioid Pain Candidate

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  • Biogen Inc BIIB has announced topline results from its Phase 2 CONVEY study of vixotrigine (BIIB074) for small fiber neuropathy (SFN).
  • SFN is a disorder in which only the small sensory cutaneous nerves are affected and is often characterized by severe pain that typically begins in the feet or hands.
  • Vixotrigine is a non-opioid investigational oral pain drug.
  • The CONVEY study 200 mg twice daily arm met its primary endpoint of change from baseline to week 12 in mean average daily pain (ADP) score. 
  • Numeric advantage of 200 mg over placebo was observed in additional secondary endpoints, including the proportion of participants with at least 2-point improvement in the average daily pain score and the proportion of participants with over 30% reduction in ADP at week 12, but these did not meet statistical significance.
  • While the 350 mg twice daily arm did not meet the primary endpoint, it met statistical significance in the Patient Global Impression of Change (PGIC) at week 12, a self-reported measure of a patient's overall improvement.
  • The totality of data from the vixotrigine program will inform potential doses for study in future Phase 3 clinical trials.
  • Both doses of vixotrigine were generally well tolerated. 
  • Vixotrigine (BIIB074) is an investigational peripherally and centrally acting, orally-administered, voltage- and use-dependent voltage-gated sodium channel blocker. 
  • UBS analyst Colin Bristow maintains Biogen with a Buy and lowers the price target from $475 to $442.
  • Price Action: BIIB stock is up 0.60% at $301.02 during the market session on the last check Thursday.
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Posted In: BiotechNewsHealth CareGeneralBriefsPhase 2 Trial
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