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news.A drug that is being developed by Theravance Biopharma and Mylan has shown promise in two phase 3 efficacy studies treating patients with chronic obstructive pulmonary disease.
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The drug, revefenacin, a once-daily nebulized bronchodilator, met primary efficacy endpoint and is shown to be well-tolerated in both studies.
The studies, which lasted for 12 weeks, included a combined total of 1,250 patients with moderate to very severe COPD. Groups were divided into two dosing groups: 88mcg and 175mcg.
Patients who received 88 microgram daily doses and 175 microgram daily doses of the drug both saw improvements in trough forced expiratory volume (FEV), their ability to exhale with force in one second, over subjects receiving a placebo drug.
The pre-specified pooled analyses results demonstrated that revefenacin produced increases in trough FEV1 in a subgroup (38%) of patients using background long-acting beta agonist (LABA) therapy and in a subgroup of patients who were not using concomitant LABA therapy, when compared to placebo.
The LABA subgroup had FEV1 improvements of 92mL and 135mL for the 88mcg and 175mcg doses, respectively.
For the non-LABA group the improvements were higher, at 131mL and 150mL for 88mcg and 175mcg, respectively.
Both doses were generally well tolerated, with comparable rates of adverse events (AEs) between the active and placebo groups. Exacerbations, cough, dyspnea and headache were the most commonly reported AEs.
Theravance Biopharma chief medical officer Brett Haumann said: “The impressive improvements in FEV1 have exceeded our expectations, particularly when one considers that in nearly 40% of the patients we added revefenacin to their existing LABA or LABA/ICS therapy.
“These data confirm that revefenacin has the potential to offer meaningful benefits to patients with moderate to very severe COPD.”
A safety study of revefenacin (TD-4208) is currently ongoing in over 1,050 patients. It is expected to be completed in 2017.
Based on the outcomes of the safety study, Theravance expects to file a new drug application to the US Food and Drug Administration by the end of 2017.
Image: Theravance Biopharma and Mylan announce positive results from two phase 3 studies of revefenacin for the treatment of COPD. Photo: courtesy of jk1991 at FreeDigitalPhotos.net.