Luxembourg-based Covis Pharma Group has released positive topline data from its Phase III AVANT trial, which assessed the efficacy of two chronic obstructive pulmonary disorder (COPD) therapies, Duaklir (aclidinium bromide 400µg/formoterol 12µg twice-daily) and Eklira/Tudorza (aclidinium bromide 400µg twice-daily), compared to placebo. The trial, which recruited 70% of patients from China, demonstrated statistically and clinically significant improvements in key endpoints for adult patients with moderate to severe stable COPD, according to the press release.
Background on the Therapies
Covis acquired the global rights to Duaklir and Eklira from AstraZeneca in a deal worth USD 270 million in November 2021. AstraZeneca had originally acquired both drugs from Spain’s Almirall in 2014. Eklira is a long-acting muscarinic antagonist (LAMA), while Duaklir is a combination therapy that includes both a LAMA and a long-acting beta2-agonist (LABA). Both drugs are sold in dry powder form for inhalation and are delivered via a multi-dose inhaler.
Trial Details and Results
The AVANT trial, conducted by AstraZeneca, recruited 1,060 patients with moderate-to-severe COPD, with over 70% of participants from mainland China and Taiwan, and additional sites in India, Vietnam, and the Philippines. The primary efficacy endpoints of the study included changes in baseline forced expiratory volume in one second (FEV1) for aclidinium/formoterol versus aclidinium alone, and the change from baseline in morning pre-dose FEV1 for aclidinium/formoterol versus formoterol and aclidinium versus placebo. The trial achieved statistically and clinically important outcomes for all key endpoint measures of efficacy, highlighting the potential benefits of these therapies for COPD patients.
Next Steps
Analysis of the data from the AVANT trial is ongoing, with Covis Pharma preparing to submit a market approval filing to China’s National Medical Products Administration (NMPA). The positive results from this trial represent a significant step forward in the development of effective treatments for COPD, a condition that affects millions of people worldwide.
Conclusion
The positive outcomes from Covis Pharma’s Phase III AVANT trial for Duaklir and Eklira underscore the potential of these therapies to improve the lives of patients with chronic obstructive pulmonary disorder. With a strong focus on the Chinese market and preparations for regulatory approval underway, Covis Pharma is poised to make a significant impact in the COPD treatment landscape.-Fineline Info & Tech
