Theravance Biopharma and Mylan have started a Phase III programme for revefenacin (TD-4208), an investigational long-acting muscarinic antagonist (LAMA) being developed to treat chronic obstructive pulmonary disease (COPD).
Designed to support the registration of revefenacin in the US, the development programme includes two replicate three-month Phase III efficacy studies and a single 12-month Phase III safety study.
A total of 2,300 patients will be enrolled in all the three trials, which will examine two doses 88mcg and 175mcg of revefenacin inhalation solution administered once-daily via nebuliser in moderate to severe COPD patients.
Theravance Biopharma Clinical Development senior vice-president Brett Haumann said: "Despite the fact that once-daily LAMAs are the first-line therapy for patients with moderate-to-severe COPD, there still are no nebulised LAMA treatments available today.
"This unmet need is significant when one considers that approximately 9% of COPD patients in the US currently use nebulisers for ongoing maintenance therapy, and a total of 41% of US COPD patients use nebulizers for bronchodilator therapy at some time during the course of their disease.
"Based on data that we've generated to date, we believe that revefenacin possesses the product profile that could uniquely and effectively address this market need."
Mylan and Theravance will jointly carry out this Phase III programme to generate the data required to support a regulatory filing for the product.
The replicate, randomised, double-blind, placebo-controlled, parallel-group Phase III efficacy trials are designed to provide pivotal efficacy and safety data for once-daily revefenacin over a dosing period of 12 weeks, with a primary endpoint of trough forced expiratory volume in one second (FEV1) on day 85.
The Phase III safety trial is an open-label, active comparator study of 12 months duration.
Mylan president Rajiv Malik said: "The initiation of this Phase III programme is an important milestone for Mylan as we continue to further build out our global respiratory pipeline.
"Revefenacin is highly complementary to our currently marketed nebulised COPD product, Perforomist Inhalation Solution, as well as other respiratory products in our pipeline."
According to Theravance, results will available from the two efficacy studies in 2016, with the results of the safety study available in 2017.
The company has also completed a Phase IIb programme with revefenacin, administered once-daily via nebuliser for up to 28 days in a moderate-to-severe COPD population.