Theravance Phase 4 COPD trial disappoints

Theravance Biopharma, Inc. (NASDAQ: TBPH) today announced results from the Phase 4 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.
• YUPELRI demonstrated safety and tolerability consistent with its profile in previous clinical studies.

https://www.prnewswire.com/news-releases/theravance-biopharma-announces-results-from-the-phase-4-yupelri-pifr-2-study-in-patients-with-severe-to-very-severe-chronic-obstructive-pulmonary-disease-copd-302026980.html