Results from phase IV Yupelri (revefenacin) PIFR-2 study in patients with severe to very severe chronic obstructive pulmonary disease -- Theravance BioPharma.
Theravance Biopharma, Inc. announced results from the Phase IV PIFR-2 study of Yupelri (revefenacin) inhalation solution, the only once-daily, nebulized long-acting muscarinic antagonist (LAMA) approved in the U.S. for maintenance treatment of COPD.
The PIFR-2 study aimed to demonstrate greater improvement in lung function for Yupelri delivered via standard jet nebulizer compared to Spiriva (tiotropium) delivered via a dry powder inhaler (Spiriva HandiHaler) in adults with severe to very severe COPD and suboptimal peak inspiratory flow rate (PIFR).
The study did not show a statistically significant difference between Yupelri and Spiriva HandiHaler on the primary endpoint, change from baseline in trough forced expiratory volume in one second (FEV1) at Day 85. Similar lung function improvement was demonstrated in both arms of the study. demonstrated safety and tolerability consistent with its profile in previous clinical studies.
Chief Executive Officer Rick E Winningham said: "While the primary endpoint in the Phase IV PIFR-2 study was not met, Yupelri demonstrated an efficacy and safety profile consistent with its performance in other clinical studies. We appreciate the growth opportunities that lie ahead for Yupelri , which is an important option for COPD maintenance care, and look forward to sharing additional details from PIFR-2 in the future, following additional data analyses."
About the PIFR-2 Study ; The Phase IV PIFR-2 Study (NCT05165485) is a randomized, double-blind, parallel-group study, comparing improvements in lung function in adults with severe to very severe COPD (FEV1 less than 50% of predicted) and suboptimal PIFR (less than 55 L/min) following once-daily treatment over 12 weeks with either Yupelri (revefenacin) inhalation solution delivered via standard jet nebulizer or Spiriva (tiotropium) delivered via a dry powder inhaler (Spiriva HandiHaler). Yupelri is approved in the U.S. for the maintenance treatment of patients with COPD; Spiriva HandiHaler is approved in the U.S. for the long-term, once-daily, maintenance treatment of bronchospasm associated with COPD, and for reducing COPD exacerbations.
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