AVANT phase III trial for Duaklir and Eklira achieved statistical significance in chronic obstructive pulmonary disease
Covis Pharma announced positive topline results from the AVANT phase III clinical trial for Duaklir (aclidinium bromide 400µg /formoterol 12µg twice-daily) and Eklira (aclidinium bromide 400µg twice-daily) – known as Tudorza in the U.S. This 24-week study achieved statistically significant and clinically important outcomes for all key endpoint measures of efficacy in adult patients with moderate to severe stable chronic obstructive pulmonary disease (COPD)
The primary efficacy endpoints of the study were a change in baseline of FEV1 of the 1-hour morning post-dose FEV1 for aclidinium/formoterol versus aclidinium, and the change from baseline of the morning pre-dose FEV1 of aclidinium/formoterol versus formoterol and aclidinium versus placebo. A total of 1,060 patients with moderate to severe stable COPD were included in the trial. Seventy percent of the participants were from China, with other participants coming from Taiwan, India, Vietnam, and the Philippines. Patients were randomized equally to placebo, aclidinium bromide monotherapy (Eklira), aclidinium bromide/formoterol fumarate combination therapy (Duaklir), and monotherapy formoterol for a 24-week period. There were no new safety concerns raised in the study and the findings were consistent with the known safety profiles of aclidinium bromide and aclidinium bromide/formoterol. The safety and tolerability of both aclidinium and aclidinium/formoterol were comparable to placebo. Detailed results of the study are planned for future publication. A full analysis of the AVANT data is ongoing with complete results to be provided, or submitted with the AVANT NDA, to the China Food and Drug Administration (CFDA).
AstraZeneca, who performed the study, transferred its global rights for Duaklir and Eklira to Covis in November 2021. Eklira (aclidinium bromide) and Duaklir (aclidinium bromide/formoterol) are inhaled respiratory medicines used for the maintenance treatment of COPD. Eklira is a long-acting muscarinic antagonist (LAMA), which is marketed in the US as Tudorza and in some countries as Bretaris. Duaklir is a combination therapy that contains both a LAMA and a long-acting beta2-agonist (LABA). It is marketed in some countries as Brimica. Both medicines are presented as a dry powder for oral inhalation and are delivered via a breath-actuated multi-dose dry powder inhaler, Genuair (Pressair in the US).
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