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Theravance Biopharmacy (NASDAQ: TBPH) lost ~16% premarket on Friday after announcing that Yupelri, its FDA-approved therapy for the lung disorder chronic obstructive pulmonary disease (COPD), failed to meet the primary endpoint in a Phase 4 trial.
However, the company said the once-daily inhalation solution did indicate a safety and tolerability profile consistent with findings from previous clinical trials.
The PIFR-2 trial evaluated Yupelri against Spiriva (tiotropium), an FDA-approved medication marketed by German manufacturer Boehringer Ingelheim as a long-term maintenance therapy for patients with COPD.
The 12-week trial enrolled adults with severe COPD who received Yupelri via a standard jet nebulizer or Spiriva via a dry powder inhaler (Spiriva HandiHaler).
At day 85, PIFR-2 did not show a statistically significant difference between Yupelri and Spiriva HandiHaler for its primary endpoint, forced expiratory volume in one second (FEV1), a measure of lung function.
Theravance (TBPH) intends to share additional data from the trial in the future following further analysis.
