Verona Pharma is aiming to start second part of Phase 2 trial to test ensifentrine DPI formulation in patients with moderate-to-severe COPD over one week of twice-daily treatment, it said after announcing positive data from part one of the trial.
The positive interim efficacy and safety data from part one of a two-part Phase 2 clinical trial of a dry powder inhaler (“DPI”) formulation of ensifentrine in patients with moderate-to-severe chronic obstructive pulmonary disease (“COPD”) was announced Monday.
“The large bronchodilator response, 12-hour duration of action and good tolerability observed with the DPI ensifentrine formulation in the first portion of this study are very encouraging and we look forward to proceeding with the second part to evaluate treatment over a one-week period,” said Jan-Anders Karlsson, PhD, CEO of Verona Pharma.
An estimated 5.5 million people in the US alone use inhalers for the maintenance treatment of COPD.1 Delivery of a DPI formulation of ensifentrine creates exciting new opportunities for combining ensifentrine with existing therapeutics delivered by handheld inhalers. The value of the COPD maintenance market delivered via inhaler devices in the US alone was approximately $6 billion in 2017, the company said in the press release.