Theravance Biopharma and Mylan Report Additional Positive Phase 3 Data for Revefenacin (TD-4208) in Multiple Presentations at 2017 CHEST Annual Meeting
24-Hour Serial Spirometry Subgroup
The first presentation highlighted prespecified exploratory efficacy outcomes for the 264-patient subgroup that underwent 24-hour serial spirometry following the last dose of revefenacin on day 84 in the replicate Phase 3 studies (0126 and 0127). Results demonstrated statistically significant and clinically meaningful improvements for revefenacin over placebo in trough forced expiratory volume in one second (FEV1) at all time points measured in each study over 24 hours post-dose.1 The improvements in trough FEV1 versus placebo (0-24 h) were 111-185 mL and 154-269 mL for 88 mcg and 175 mcg, respectively (p < 0.01).
St. George's Respiratory Questionnaire (SGRQ) and COPD Assessment Test (CAT)
An additional presentation on the Phase 3 studies reported results from a prespecified secondary analysis which measured changes in patient health status using the St. George's Respiratory Questionnaire (SGRQ) and COPD Assessment Test (CAT). In the first Phase 3 trial (Study 0126), researchers reported clinically meaningful improvements in SGRQ for revefenacin as compared to placebo in both the responder and total score analyses. Treatment with both doses of revefenacin led to statistically significant improvements in total CAT scores (p ≤ 0.001), as well as the percentage of patients who experienced clinically meaningful improvements in total CAT score (p ≤ 0.05), as compared to placebo.
In the second Phase 3 (Study 0127), improvements in SGRQ in both the responder and total score analyses were similar for both revefenacin doses. However, due to a greater than expected placebo response in this study, only the change from baseline analysis for subjects receiving 175 mcg reached statistical significance over placebo. Treatment with 175 mcg of revefenacin led to statistically significant improvements in total CAT scores (p < 0.05), as well as an increase in the percentage of patients who experienced clinically meaningful improvements in total CAT score (p ≤ 0.05), as compared to placebo. While the 88 mcg dose of revefenacin also led to improvements in total CAT scores and an increase in the percentage of patients who experienced clinically meaningful improvements in total CAT score as compared to placebo, these results did not reach statistical significance due to the greater than expected placebo response in this study.
"These latest data sets from our replicate Phase 3 efficacy studies of revefenacin provide important additional detail and context around the therapeutic potential of this drug for COPD patients. We are particularly pleased to see that the statistically significant improvements in FEV1 demonstrated with revefenacin as compared to placebo in the complete Phase 3 patient population were consistent with the results seen in the 24-hour serial spirometry study subgroup," said
COPD is a growing and devastating disease that is the third leading cause of death in the U.S.2 An estimated 12.7 million American adults are diagnosed with COPD and an almost equal number are believed to be undiagnosed.3There were more than 700,000 hospital discharges related to COPD in the U.S. reported in 2010. The costs of managing COPD in the U.S. were estimated to be nearly
Revefenacin (TD-4208) is a novel investigational once-daily nebulized LAMA in Phase 3 development for the treatment of moderate to very severe COPD. Market research by
Our pipeline of internally discovered product candidates includes potential best-in-class medicines to address the unmet needs of patients being treated for serious conditions primarily in the acute care setting. VIBATIV® (telavancin), our first commercial product, is a once-daily dual-mechanism antibiotic approved in the U.S.,
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Mylan is a global pharmaceutical company committed to setting new standards in healthcare. Working together around the world to provide 7 billion people access to high quality medicine, we innovate to satisfy unmet needs; make reliability and service excellence a habit; do what's right, not what's easy; and impact the future through passionate global leadership. We offer a growing portfolio of more than 7,500 marketed products around the world, including antiretroviral therapies on which approximately 50% of people being treated for HIV/AIDS in the developing world depend. We market our products in more than 165 countries and territories. We are one of the world's largest producers of active pharmaceutical ingredients. Every member of our more than 35,000-strong workforce is dedicated to creating better health for a better world, one person at a time. Learn more at Mylan.com.
This press release includes statements that constitute "forward-looking statements," including with regard to the outcome of clinical trials; that
1 "Clinically meaningful" is defined by industry established Minimal Clinically Important Difference (MCID) for lung function (100 ml improvement in FEV1), SGRQ (change from baseline of -4), CAT (change from baseline of -2).
4 TBPH market research (N = 160 physicians); Refers to US COPD patients
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Theravance Biopharma: Alexander Dobbin, Head of Investor Relations, 650-808-4045, firstname.lastname@example.org; Tim Brons, Vida Strategic Partners (media), 646-319-8981, email@example.com; Mylan: Media: 724.514.1968, Melissa Trombetta (Investor Relations), 724.514.1813