Viatris, Theravance Biopharma announce results from YUPELRI

Viatris (VTRS) and Theravance Biopharma (TBPH) announced positive results from the YUPELRI Phase III placebo-controlled clinical trial conducted in China assessing the efficacy and safety of YUPELRI, a once-daily nebulized long-acting muscarinic antagonist, LAMA, for the maintenance treatment of patients with COPD. Top-line results showed that YUPELRI met its primary efficacy endpoint demonstrating a statistically significant increase in trough FEV1 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. Top Line Results Highlights: A total of 258 patients enrolled with 257 included in safety and full analysis sets. Both groups were well balanced for baseline characteristics with 129 treated with YUPELRI and 128 treated with placebo. Study population was moderate to very severe COPD patients with mean baseline FEV1 approximately 50% predicted. Approximately two-thirds of patients remained on long-acting beta-2 agonist/inhaled corticosteroids throughout the study. Primary efficacy analysis of change from baseline in trough FEV1 measured 24 hours after the final dose at week 12 detected a mean treatment difference of 150.9 mL compared to placebo. Safety and tolerability profile assessed by summary of adverse events consistent with U.S. package insert.