GSK, Innoviva announce ‘positive’ data in Anoro Ellipta study 

GlaxoSmithKline (GSK) and Innoviva (INVA) announced positive data from a study comparing a once-daily long-acting muscarinic antagonist and a long-acting beta agonist fixed-dose combination, Anoro Ellipta and Stiolto Respimat, for symptomatic patients with chronic obstructive pulmonary disease.

COPD, or chronic obstructive pulmonary disease, is a progressive disease that makes it hard to breathe. Progressive means the disease gets worse over time.

COPD can cause coughing that produces large amounts of a slimy substance called mucus, wheezing, shortness of breath, chest tightness, and other symptoms.

Cigarette smoking is the leading cause of COPD. Most people who have COPD smoke or used to smoke. However, up to 25 percent of people with COPD never smoked. Long-term exposure to other lung irritants—such as air pollution, chemical fumes, or dusts—also may contribute to COPD. A rare genetic condition called alpha-1 antitrypsin (AAT) deficiency can also cause the disease.

These data have been published today in Advances in Therapy and are being presented today at the CHEST annual meeting of the American College of Chest Physicians in Toronto, Canada.

The primary endpoint for this eight-week, open-label, cross-over study of 236 patients with COPD was the demonstration of non-inferiority of UMEC/VI compared to TIO/OLO in improving lung function, as measured by trough FEV1 at week eight.

This endpoint was met, and furthermore UMEC/VI demonstrated superiority to TIO/OLO, with a difference in treatment effect of 52mL on trough FEV1 at week eight.

Both treatments demonstrated a comparable tolerability and safety profile with an overall incidence of on-treatment adverse events of 25% in the UMEC/VI group and 31% in the TIO/OLO group.

The most frequently-reported adverse events were upper respiratory tract infections, cough and diarrhoea.

INVA closed at $12.24. GSK closed at $36.43.


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