Treatment with revefenacin (TD-4208) has shown promise in a Phase 3 clinical trial (NCT02518139) with chronic obstructive pulmonary disease (COPD) patients, said Theravance Biopharma and Mylan.

Revefenacin is an investigational long-acting muscarinic antagonist (LAMA) and the first once-daily nebulized bronchodilator in development to treat COPD. The drug will be compatible with a range of jet nebulizers.

“The data from this 12-month safety study build on our observations from the previous three-month efficacy studies and suggest that revefenacin has a favorable safety and tolerability profile when dosed chronically, either as a standalone therapy or when taken as an add-on to other COPD therapies including combinations of ICS [inhaled corticosteroids] and LABA,” Dr. Brett Haumann, chief medical officer of Theravance Biopharma, said in a news release.

“As of today, there are no approved nebulized LAMAs, despite a significant number of COPD patients needing or preferring nebulized therapy for the treatment of their disease,” Haumann said. “Having achieved positive efficacy and tolerability data in our Phase 3 program, we and our partner Mylan believe that revefenacin is well positioned to address this important patient need.”

Haumann said his company, based in Ireland, remains on track to submit a new drug application to the U.S. Food and Drug Administration (FDA) late this year.

“Our revefenacin collaboration with Theravance Biopharma continues to deliver results at every step along the development path,” Mylan President Rajiv Malik said in a news release. “We are very pleased with the top-line results from the 12-month safety trial and now feel we have all the data necessary to support a successful NDA filing.

Malik said that once revefenacin wins FDA approval from the FDA, the new nebulized LAMA will be introduced “to ensure the treatment has the greatest possible impact on the lives of patients with COPD.”

The Phase 3 study enrolled 1,055 COPD patients to investigate the safety and tolerability of two revefenacin doses (88 mcg or 175 mcg, inhaled once a day with a nebulizer) for 12 months, compared to standard of care with Spiriva (tiotropium). Half of the patients enrolled were under treatment with LABA or LABA/ICS.

Detailed results from this study will be presented at future scientific meetings, but the companies revealed that treatment with both doses of revefenacin caused few adverse side effects in comparison to Spiriva, the standard of care. Common side effects included exacerbations (rates were lower in the 175 mcg group), nasopharyngitis, upper respiratory tract infections and cough.

Previous studies involving more than 1,250 COPD patients have shown that treatment with revefenacin once daily (either 88 mcg or 175 mcg) provided improved lung function, assessed by forced expiratory volume in one second (FEV1), compared to a placebo.