Yupelri Not Superior to Spiriva in Phase 4 Trial

Theravance Biopharma’s COPD treatment Yupelri was not superior to Boehringer Ingelheim’s Spiriva Handihaler, according to results from a phase 4 study reported by Theravance.

Yupelri (revefenacin) inhalation solution is a once-daily, nebulized LAMA approved for maintenance treatment of 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 is a randomized, double-blind, parallel-group study, comparing improvements in lung function in adults with severe to very severe COPD (FEV₁ <50% of predicted) and suboptimal PIFR (<55 LPM) following once-daily treatment over 12 weeks with either Yupelri inhalation solution delivered via standard jet nebulizer or Spiriva (tiotropium) delivered via a dry powder inhaler (Spiriva HandiHaler).

According to results reported by Theravance:

• 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.

Chief Executive Officer Rick E Winningham said: “While the primary endpoint in the Phase 4 PIFR-2 study was not met, Yupelri demonstrated an efficacy and safety profile consistent with its performance in other clinical studies. We appreciate the growth opportunities that lie ahead for YUPELRI, which is an important option for COPD maintenance care, and look forward to sharing additional details from PIFR-2 in the future, following additional data analyses.”