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Theravance Biopharma Inc (NASDAQ:TBPH) 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 chronic obstructive pulmonary disorder (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.
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.
In November, Viatris Inc (NASDAQ:VTRS) and Theravance Biopharma released results from the YUPELRI (revefenacin) Phase 3 placebo-controlled clinical trial conducted in China, meeting its primary efficacy endpoint, demonstrating a statistically significant increase in trough FEV1 (forced expiratory volume in one second) versus placebo.
The results are comparable to those from studies of the same design used for U.S. registration and provide support for a regulatory filing in China anticipated to occur in mid-2024.
Theravance Biopharma and Viatris co-promote Yupelri (revefenacin) in the U.S. In 2019, the companies expanded their development and commercialization agreement for nebulized revefenacin to include China and certain adjacent territories.
Price Action: TBPH shares are down 6.77% at $10.72 on the last check Friday.
