Theravance Biopharma shares fell more than 20% after the company reported that its therapeutic for chronic obstructive pulmonary disease (COPD), a common lung disease, failed a clinical trial.
Its stock was down 20.7% at US$9.14 before Friday’s opening bell.
The company said in its Phase 4 PIFR-2 Study, its YUPELRI (revefenacin) inhalation solution, which is approved in the US for the maintenance treatment of COPD, failed to meet its primary endpoint.
The study, which compared YUPELRI delivered via standard jet nebulizer to Spiriva (tiotropium) delivered via a dry powder inhaler, did not show a statistically significant difference between the two therapies in terms of change in baseline in trough forced expiratory volume in one second at Day 85.
Lung function improvement was similarly demonstrated in both arms of the study, the company 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,” Theravance CEO Rick Winningham said in a statement.
“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."