Phase 2 trial of Verona’s MDI formulation of ensifentrine meets primary and secondary endpoints

Verona Pharma reported that a Phase 2 study of 3 dose levels of its MDI formulation of ensifentrine in patients with moderate to severe COPD met all of its primary and secondary endpoints, demonstrating significant improvements in lung function compared to placebo. Improvements in peak FEV1 ranged from 205 mL for a 300 µg dose to 326 mL for a 3000 µg dose. Verona had announced positive results from the first part of the trial of the MDI formulation in March 2020 and announced initiation of the second part of the trial in August 2020.

Verona Pharma President and CEO David Zaccardelli said, “We are very encouraged by these compelling data, which are consistent with results from Phase 2 clinical trials with our nebulized and DPI formulations of ensifentrine. All three inhaled formulations have demonstrated significant improvements in lung function in COPD patients, supporting the broad utility of ensifentrine delivered via nebulizers and handheld inhalers. The development of pMDI and DPI formulations of ensifentrine provides expanded opportunities including life cycle management, new indications and partnering.”

A study of the ensifentrine MDI in patients hospitalized with COVID-19 was initiated in September 2020.

Read the Verona Pharma press release.

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