Theravance Biopharma reports PIFR-2 study missed primary endpoint

Theravance Biopharma announced results from the Phase 4 PIFR-2 study of Yupelri inhalation solution, the only once-daily, nebulized long-acting muscarinic antagonist, or 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 delivered via a dry powder inhaler in adults with severe to very severe COPD and suboptimal peak inspiratory flow rate, or 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 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.