Aclidinium Bromide/Formoterol, Aclidinium Bromide May Be Effective for Severe Stable COPD

Covis announced positive topline results for 2 new medications that can treat patients with moderate to severe stable chronic obstructive pulmonary disease.

Aclidinium bromide 400 µg/formoterol 12 µg twice-daily (Duaklir; Covis) and aclidinium bromide 400 µg twice-daily (Eklira; Covis) achieved statistically significant and clinically important outcomes in patients with moderate to severe stable chronic obstructive pulmonary disease (COPD) in a phase 3 clinical trial.1

One of the main primary endpoints of the study was a change in forced expiratory volume (FEV1) from baseline, which compares the 1-hour morning post-dose FEV1 of aclidinium/formoterol versus aclidinium. The other coprimary endpoint was a change in the FEV1 measurement from baseline after taking the morning pre-dose FEV1 of aclidinium/formoterol versus formoterol and aclidinium versus placebo.1

The FEV1 is a measurement that is taken from a pulmonary function test. It determines how much air a person can expel from their lungs in 1 second, and in effect it can be used to diagnose COPD.2

“The positive results from this phase 3 clinical trial demonstrate a promising step to expand our global respiratory portfolio into important new regions,” said Raghav Chari, PhD, chief innovation officer at Covis Pharma, in a press release.1

COPD is a progressive and worsening condition that affects breathing. In COPD, inflammation or mucus may create difficulty breathing because they can damage airways.

The FEV1 test is administered as a means of determining the severity or stage of the COPD condition.2 Bronchitis and emphysema could be classified as COPD conditions.2

The24-week AVANT phase 3 clinical trial enrolled at 1060 patients from China, Taiwan, India, Vietnam, and the Philippines, and patients had moderate to severe stable COPD. Participants were randomized to receive placebo, aclidinium bromide monotherapy, aclidinium bromide/formoterol combination therapy, and formoterol as a monotherapy. The results of the study showed that both treatments could be effective maintenance therapies for COPD.1

The safety profiles of aclidinium bromide/formoterol and aclidinium bromide were consistent with previous findings, and the tolerability of aclidinium bromide/formoterol and aclidinium bromide were comparable to the placebo.1

Respiratory medicines aclidinium bromide/formoterol and aclidinium bromide are dry powders that are inhaled in a breath-actuated multi-dose dry powder inhaler. They are used as maintenance treatment for COPD. Aclidinium bromide is a long-acting muscarinic antagonist—and aclidinium bromide/formoterol is a both a long-acting muscarinic antagonist and a long-acting beta2-agonist. 1

“These data further strengthen our confidence in these 2 medicines and support our intent to pursue the regulatory path to make these treatment options available to a broader population of COPD patients,” Chari said in the press release. 1

References

  1. Covis Pharma Group. Covis Pharma Announces Positive Topline Results from the AVANT Phase 3 Clinical Trial Showing Significant Improvement in Patients with Moderate to Severe Stable COPD. Global Newswire. October 25, 2022. Accessed on October 26, 2022. https://www.globenewswire.com/news-release/2022/10/25/2541246/0/en/Covis-Pharma-Announces-Positive-Topline-Results-from-the-AVANT-Phase-3-Clinical-Trial-Showing-Significant-Improvement-in-Patients-with-Moderate-to-Severe-Stable-COPD.html
  2. Leonard, Jayne. Forced expiratory volume (FEV1) is a measurement taken from a pulmonary function test. It calculates the amount of air that a person can force out of their lungs in 1 second. Medical News Today. November 3, 2021. Accessed on October 26, 2022. https://www.medicalnewstoday.com/articles/320168#:~:text=Forced%20expiratory%20volume%20(FEV1)%20is,obstructive%20pulmonary%20disease%20(COPD).