US-based biotech Theravance Biopharma’s chronic obstructive pulmonary disease (COPD) drug Yupelri (revefenacin) failed to meet its primary endpoint in a Phase IV clinical trial.
In the Phase IV PIFR-2 trial (NCT05165485), Yupelri didn’t yield significant differences in primary or key secondary endpoints that measure improvement in lung function. The change from baseline was evaluated using the trough forced expiratory volume in one second (FEV1)—a common COPD outcome measure— at day 85, compared to Boehringer Ingelheim’s Spiriva (tiotropium).
Findings from a separate Phase III clinical trial in China suggested that Yupelri demonstrated a statistically significant rise in trough FEV1 versus placebo patients with moderate to very severe COPD in November 2023. Phase IV studies or post-marketing studies are conducted to evaluate a newly approved drug in real-life environments over a longer period, especially its side effects.
Yupelri, a cholinergic receptor muscarinic antagonist (CRMA), works by blocking muscle-contraction neurotransmitter acetylcholine – relaxing airway muscles, and improving breathing by widening the air passages. It is an inhalation solution delivered via a nebuliser.
It was one of the first once-daily nebulised bronchodilators to be approved by the FDA – it was secured in November 2018 following two clinical trials that enrolled 813 adult patients in the US. According to GlobalData, Yupelri is forecast to generate $250m in sales in 2029.
GlobalData is the parent company of Clinical Trials Arena.
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COPD is a progressive lung disease that causes inflammation and damage to the lungs, making it difficult to breathe. According to a report on GlobalData’s Pharma Intelligence Center, COPD drug sales are forecasted to generate $19.3bn in 2028, growing at a compound annual growth rate (CAGR) of 5.9% from $10.9bn in 2018, across the seven main markets (US, UK, France, Spain, Italy, Germany, and Japan).
One of the likely major competitors in the space is Sanofi and Regeneron’s monoclonal antibody Dupixent (dupilumab). In November 2023, both companies reported positive data from the Phase III NOTUS trial (NCT04456673), where Dupixent reduced exacerbations in COPD patients by 34%.
In the announcement accompanying the study results, Theravance CEO Rick Winningham said: “While the primary endpoint in the Phase IV PIFR-2 study was not met, Yupelri demonstrated an efficacy and safety profile consistent with its performance in other clinical studies.”