Mylan and Theravance Biopharma have reported additional positive efficacy results from two Phase III clinical trials of revefenacin (TD-4208) in patients with chronic obstructive pulmonary disease (COPD).
Revefenacin is an investigational, once-daily, nebulised bronchodilator and long-acting muscarinic antagonist (Lama ).
Results showed statistically significant and clinically meaningful improvements in exploratory efficacy outcomes for the 264-patient subgroup with revefenacin, when compared to placebo.
The three-month Phase III trials, Study 0126 and Study 0127, evaluated 88µg and 175µg doses of revefenacin in a total of 1,250 patients with moderate to very severe COPD.
In both trials, clinically meaningful and statistically significant improvements were observed in St George’s Respiratory Questionnaire (SGRQ) and COPD assessment test (CAT) scores respectively.
During Study 0127, the proportion of patients achieving clinically meaningful improvements in total CAT score did not reach statistical significance with the 88µg dose.
Mylan president Rajiv Malik said: “These new results, combined with efficacy and safety studies presented earlier this year, give us positive momentum as we prepare our new drug application for revefenacin.”
In collaboration with Momenta Pharmaceuticals , Mylan also announced initial results from a Phase I trial of M834 in 243 healthy subjects.
M834 is a proposed biosimilar of Orencia (abatacept), which is a fused protein approved for the treatment of rheumatoid, psoriatic and juvenile idiopathic arthritis.
Conducted with single-dose subcutaneous injection of M834 to assess pharmacokinetics, safety and immunogenicity, the randomised, double-blind, three-arm, parallel group Phase I trial did not meet the primary endpoints compared to US and EU-sourced Orencia.