PITTSBURGH, PA - Viatris Inc. (NASDAQ: VTRS), a global healthcare company, and Theravance Biopharma, Inc. (NASDAQ: TBPH) today announced positive results from the YUPELRI® (revefenacin) 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 (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.
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 (95% confidence intervals) treatment difference of 150.9 (104.1, 197.7) mL compared to placebo.
- Safety and tolerability profile assessed by summary of adverse events consistent with U.S. package insert.
Viatris President Rajiv Malik said, "We are pleased with the positive top-line results of our Phase III clinical results for YUPELRI in China. The strength of the data and the primary endpoint analysis, which is consistent with our U.S. clinical data, firmly supports a comparable efficacy and safety profile of YUPELRI. With this data, we look forward to progressing our regulatory application in China and continue to believe, when approved, a once-daily nebulized revefenacin product will be an important therapeutic option for the millions of patients in the region with COPD."
"Given its novel profile, we and Viatris share a commitment to make YUPELRI available for as many COPD patients as possible, particularly those who stand to benefit from nebulized therapy, and we commend VIATRIS on the execution of this study," said Rick E Winningham, CEO of Theravance Biopharma. "The consistent lung function improvement demonstrated in this study supports the use of LAMA therapy as foundational in a range of patients and we are encouraged that COPD patients in China may soon have the opportunity to benefit from a new, valuable treatment option."
It is estimated that COPD affects nearly 100 million individuals in China1 with approximately 43 percent of those patients suffering from moderate to very severe forms of the disease2. COPD is one of the top three causes of mortality in China, accounting for approximately 910,000 deaths annually3. COPD presents a significant financial burden to the healthcare system in China, contributing up to $266 billion in costs annually2.
About the Study
The Phase III study was designed to compare the efficacy and safety of revefenacin (175mcg) and double-blind placebo nebulized once-daily in moderate to very severe COPD patients in China over a 12-week treatment period.
About Theravance Biopharma / Viatris Collaboration
Theravance Biopharma and Viatris Inc. and their respective affiliates have established a strategic collaboration to develop and commercialize nebulized revefenacin products for COPD and other respiratory diseases. Theravance Biopharma and Viatris co-promote YUPELRI® (revefenacin) in the U.S., with their combined sales infrastructure targeting healthcare professionals who treat COPD patients suitable for YUPELRI. In 2019, the companies announced the expansion of their development and commercialization agreement for nebulized revefenacin to include China and certain adjacent territories, which include Hong Kong SAR, the Macau SAR and Taiwan.