Theravance Biopharma Inc.’s stock (TBPH) took a significant hit, tumbling 21% on Friday, following the announcement that its Phase 4 trial for Yupelri treatment did not achieve the desired outcome. Yupelri was developed to help patients suffering from severe to very severe Chronic Obstructive Pulmonary Disease (COPD).
The clinical trial, known as PFIR-2, aimed to demonstrate that Yupelri, delivered through a standard jet nebulizer, would result in greater improvement in lung function compared to Spiriva, which is administered via a dry powder inhaler in adult COPD patients. However, the study failed to show a statistically significant difference between Yupelri and Spiriva HandiHaler on the primary endpoint, which measured the change in trough forced expiratory volume in one second (FEV1) from baseline at Day 85.
Despite this setback, the trial did show comparable lung function in both treatment groups and confirmed that Yupelri maintained safety and tolerability consistent with previous studies. It is important to note that YUPELRI is already approved in the U.S. for the maintenance treatment of COPD patients. On the other hand, Spiriva HandiHaler is approved for long-term, once-daily maintenance treatment of bronchospasm associated with COPD, as well as for reducing COPD exacerbations.
Investors reacted swiftly to this news, causing Theravance Biopharma Inc.’s stock to drop. Over the past 12 months, the company’s stock has gained 4%, compared to a 23% gain in the S&P 500.
While this setback is disappointing, Theravance Biopharma Inc. remains committed to advancing research and finding effective treatments for patients with COPD. The company will continue to explore new opportunities and potential improvements in the field, as it strives to make a positive impact on patients’ lives.