Verona Pharma shares surge after results from latest study

Respiratory disease-focussed biopharmaceuticals company Verona Pharma announced positive top-line data from a four week, 416 patient phase 2b dose-ranging study evaluating nebulised ensifentrine or placebo as an add-on treatment to ‘Spiriva Respimat’, or tiotropium, which is a long acting anti-muscarinic bronchodilator, in patients with moderate-to-severe chronic obstructive pulmonary disease (COPD).

The AIM-traded firm said the study met its primary endpoint of improved lung function, with ensifentrine added on to inhaled tiotropium, a long acting anti-muscarinic commonly used to treat COPD.

It said ensifentrine produced a “clinically and statistically significant” and dose-dependent improvement in peak forced expiratory volume in one second at week four, compared to placebo added on to tiotropium.

The primary endpoint was met at all doses, which was a statistically significant and clinically meaningful improvement in lung function at week four.

Improvements ranged from 78 mL for the 0.375 mg dose to 124 mL for the 3.0 mg dose, with the effects maintained over four weeks.

Verona said clinically meaningful improvements in health-related quality of life were observed on top of tiotropium, exceeding the minimal clinically important difference of four units compared to placebo at week four, with the two highest doses also achieving statistical significance.

Ensifentrine was said to be well tolerated at all doses, with an adverse event profile similar to placebo.

Verona said the data supported dose selection for phase 3.

“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,” said Gary Ferguson, a pulmonary physician and principle investigator at the Pulmonary Research Institute of Southeast Michigan.

“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.”

Jan-Anders Karlsson, chief executive officer of Verona Pharma, said the company was “delighted” with the results in symptomatic COPD patients already on steady-state maintenance treatment with a long acting anti-muscarinic (LAMA) bronchodilator.

“These data bring clarity to planning the design, including dose selection, endpoints and background therapy, of our phase 3 programme.

“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 2 meeting with the FDA planned for the second quarter of 2020.

“We are committed to demonstrating ensifentrine’s potential to produce sustained bronchodilation and anti-inflammatory effects in symptomatic COPD patients in phase 3 trials, which we expect to start in the third quarter of 2020.”

At 1103 GMT, shares in Verona Pharma had surged 53.17% in London, to 88.84p.