Verona Pharma PLC (LON:VRP, NASDAQ:VRNA) shares soared higher on Monday after a phase IIb study of the firm's drug for chronic obstructive pulmonary disease (COPD) delivered "impressive" results.
At one point, Verona Pharma shares were more than 60% higher at 92.50p, the London market's top riser.
In a statement, the company said its nebulized ensifentrine treatment was given as an add-on to the current established medication called tiotropium, a long-acting anti-muscarinic, which relaxes and enlarges the airways in the lung.
The combination had a “strong effect” on both bronchodilation (opening of the airways) and quality of life.
The Verona drug, therefore, hit its “primary endpoint” (goal) of a clinically and statistically significant dose-related positive effect on lung function when compared with a group taking a placebo with no medical benefit.
Gary Ferguson led the four-week study of 416 people with COPD that saw the group receiving the medication get doses of between 0.375 milligrams (mg) and 3mg.
“The strong effect on both bronchodilation and quality of life as an add-on to tiotropium is impressive and consistent with prior studies with ensifentrine,” he said in a statement.
“I am particularly interested to see the significant improvements in quality of life measurements over the four-week treatment period. This is very important for patients that remain symptomatic despite using standard COPD medications.”
“Clarity” to trial design planning
Verona’s chief executive, Jan-Anders Karlsson said the results brought “clarity” to planning the design of the company’s phase III trial, expected to kick off in the third quarter of this year.
The phase II assessment provided invaluable pointers on “dose selection, endpoints and background therapy”, he added.
“We look forward to discussing these new and compelling data, together with the positive results from our previous clinical studies, in an end-of-phase II meeting with the FDA [US Food & Drug Administration] planned for the second quarter of 2020,” said the Verona CEO.
COPD is a progressive and life-threatening respiratory disease without a cure. In the US alone, the annual bill to treat people with the disease is expected to be US$49bn this year.