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Theravance Biopharma disclosed that its Phase 3 CYPRESS Study for ampreloxetine in patients with symptomatic…
TBPHTheravance Biopharma, Inc.
Theravance Biopharma disclosed that its Phase 3 CYPRESS Study for ampreloxetine in patients with symptomatic neurogenic orthostatic hypotension associated with multiple system atrophy failed to achieve statistical significance on the primary endpoint, a change in OHSA composite score at week 8. While secondary endpoints showed similar trends and biomarkers confirmed biological activity, the company conducted post hoc analyses suggesting treatment benefits in a more focused patient population. The FDA indicated that current data would not support approval but an additional pivotal trial could offer a path forward. Theravance has requested a Type C meeting with the FDA to align on future study design. Theravance Biopharma is a biopharmaceutical company developing treatments for neurological and respiratory diseases.