The proposed once-daily nebulized bronchodilator for COPD returned reports of generally positive toleration, with no new safety issues, in a study of 1,055 patients.
A year-long Phase III study of a chronic obstructive pulmonary disease (COPD) treatment has shown positive results in trials involving over 1,000 patients.
Investigational long-acting muscarinic antagonist (LAMA) revefenacin (TD-4208), a proposed once-daily nebulized bronchodilator for COPD, returned reports of generally positive toleration, with no new safety issues, in a study of 1,055 patients.
The adverse event (AE) rates returned were low and comparable to standard treatment of COPD.
The Phase III study included a randomized, active-controlled parallel group trial of 2 different revefenacin doses: 88 mcg or 175 mcg, inhaled via a nebulizer once daily. Researchers tested the drug's fixed-dosage safety and tolerability over 52 weeks, versus standard-of-care tiotropium (Spiriva). The revefenacin participants comprised half of the study's patient pool.
The other half of COPD patients received other therapies, such as long-acting beta-agonists (LABA) or LABA/inhaled corticosteroids (ICS).
Trial data showed a low rate of common and severe AEs for both doses of revefenacin versus tioropium. Commonly-reported AEs included exacerbations, nasopharyngitis, upper respiratory tract infections, and cough. COPD exacerbation rates were numerically lowest in the 175 mcg group.
Study-supporting companies Theravance Biopharma and Mylan previously reported positive results on 2 pivotal Phase III efficacy studies of revefenacin. The studies, which included over 1,250 moderate-to-very-severe COPD patients, showed statistically significant and clinically meaningful improvements over placebo in trough forced expiratory volume in one second (FEV1) and in overall treatment effect on trough FEV1 (OTE FEV1) after 12 weeks of dosing.
The safety and tolerability study results builds on the observations of previous efficacy studies for revefenacin, Brett Haumann, MD, Chief Medical Officer atTheravance Biopharma, said.
"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 III program, we and our partner Mylan believe that revefenacin is well positioned to address this important patient need."
The combined data of studies will support the anticipated US Food and Drug Administration (FDA) application of revefenacin for COPD, which could be submitted in the fourth quarter of 2017.
Mylan President Rajiv Malik was pleased with the 12-month safety study results, saying the company believes it now has all the data necessary for a "successful New Drug Application (NDA) filing."
"Should revefenacin receive approval from the FDA, we look forward to introducing this nebulized LAMA, to ensure the treatment has the greatest possible impact on the lives of patients with COPD," Malik said.
A press release regarding the study was made available.