Benzinga | Sep 16, 2021 07:32AM EDT

Biogen Announces Topline Results from Phase 2 CONVEY Study in Small Fiber Neuropathy; Co. Reports 'The CONVEY study 200 mg twice daily arm met its primary endpoint while the 350 mg twice daily arm did not meet the primary endpoint'

Biogen Inc. (NASDAQ:BIIB) today announced positive topline results from its Phase 2 CONVEY study of vixotrigine (BIIB074), a non-opioid investigational oral pain drug being evaluated for the treatment of small fiber neuropathy (SFN).



The CONVEY study 200 mg twice daily arm met its primary endpoint of change from baseline to week 12 of the double-blind period in mean average daily pain (ADP) score. In this study, all participants who enrolled received the higher dose (350 mg twice daily) in an open-label portion which preceded the double-blind portion of the study. 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, an important self-reported measure of a patient's overall improvement since with the start of the study. The totality of data from the vixotrigine program will inform potential doses for study in future Phase 3 clinical trials. There is a significant unmet need for non-opioid treatments for people suffering from chronic neuropathic pain.

Small fiber neuropathy is often characterized by severe pain that typically begins in the feet or hands. Painful symptoms are described as burning, shooting and/or prickling. Pain can be caused by stimuli that does not normally provoke pain (allodynia) and potentially painful stimuli are increased in intensity (hyperalgesia). Symptoms tend to be worse at night and during periods of rest and can lead to a significant impact on overall quality of life.