New phase III data for Yupelri in COPD presented at CHEST.- Theravance Biopharma.

Theravance Biopharma announced positive new data from multiple studies of Yupelri (revefenacin) inhalation solution. New data from a randomized, double-blinded study comparing the efficacy of Yupelri to tiotropium in patients with moderate to very severe COPD and suboptimal peak inspiratory flow rates (PIFR) (less than 60 L/min) showed that the Yupelri group showed improvements in trough FEV1 and trough FVC on day 29 compared with tiotropium group; however, these differences did not reach statistical significance. In the prespecified analysis of subjects with severe to very severe COPD (FEV1 less than 50% predicted), which represented approximately 80% of the study population, Yupelri demonstrated statistically significant improvements in trough FEV1 and FVC as compared to tiotropium. No new adverse events were noted.

Researchers also presented prespecified analyses of data from the Yupelri Phase III program, highlighted by the demonstration of efficacy advantages for Yupelri dosed at 175 mcg once daily compared to Yupelri dosed at 88 mcg once daily in four subgroups of patients categorized as being at risk of COPD exacerbations based on markers of more severe COPD. Pooled data from the two replicate 12-week pivotal Phase III efficacy trials demonstrated that Yupelri dosed at 175 mcg once daily produced greater improvements in trough FEV1 than Yupelri dosed at 88 mcg once daily in each of the four analyzed subgroups. These efficacy trends favouring the 175 mcg once daily dose in the subgroups are consistent with those reported for the entire intent-to-treat population in the two Phase III efficacy trials. Additionally, data from the 12-month Phase III safety trial demonstrated that Yupelri dosed at 175 mcg once daily produced greater improvements in trough FEV1 than Yupelri dosed at 88 mcg once daily in the LABA subgroup. The Yupelri doses were equally effective at improving trough FEV1 in the ICS and elderly subgroups in the 12-month safety study.

Finally Researchers conducted a review of cardiovascular safety data from four clinical studies of Yupelri including the two replicate 12-week pivotal Phase III efficacy trials, the 12-month Phase III safety trial and a Phase I QT study in healthy subjects. The data analysis demonstrated that once-daily Yupelri dosed for up to 52 weeks did not prolong QT interval or increase risk of major adverse cardiac events. Data were presented at the 2018 CHEST annual meeting.