Verona Pharma PLC (LON:VRP, NASDAQ:VRNA) looks set to make rapid progress following the completion of recruitment for a phase IIb study that will assess the safety and efficacy of its inhaled drug for severe chronic obstructive pulmonary disease (COPD).
The treatment, nebulized ensifentrine, will be used in harness with a long acting bronchodilator to help people with moderate-to-severe forms of the disease.
The read-out from the study is expected around the end of the year.
After that, Verona’s team will sit down with US Food & Drug Administration for what’s called an 'End of Phase II Meeting'.
A phase III clinical assessment will get under way next year.
Ensifentrine is being developed to be the first new bronchodilator in almost 40 for COPD, a progressive and life-threatening and is caused by long-term exposure to lung irritants such as tobacco smoke.
The cost of treatment in the US alone is put at US$49bn annually.
“Millions of COPD patients urgently need better treatments as they remain symptomatic despite maximum treatment with currently available therapies,” Verona chief executive Jan-Anders Karlsson said.
“We believe ensifentrine, with its unique mode of action and clinical profile, will have an important role in treating these patients.”
In all, 416 people have been recruited into the four-week trial that’s taking place over 46 sites in the US.
It is a randomised, double-blind and placebo-controlled dose-ranging trial, which means researchers will only know who had the active drug at the end of the process.