Covis Pharma Group (“Covis”), a global specialty pharmaceutical company that markets therapeutic solutions for patients with life-threatening conditions and chronic illnesses, today announced positive topline results from the AVANT phase 3 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.
AstraZeneca, who performed the study, transferred its global rights for Duaklir and Eklira to Covis in November 2021.
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