Ensifentrine delivery via MDI inhalers could dramatically expand clinical utility and commercial opportunity

LONDON, June 04, 2019 (GLOBE NEWSWIRE) -- Verona Pharma plc (AIM: VRP) (Nasdaq: VRNA) (“Verona Pharma”), a biopharmaceutical company focused on respiratory diseases, announces the initiation of a Phase 2 dose-ranging trial to evaluate the pharmacokinetic (“PK”) profile, efficacy and safety of a pressurized metered-dose inhaler (“MDI”) formulation of ensifentrine (RPL554) in patients with moderate-to-severe chronic obstructive pulmonary disease (“COPD”). Verona Pharma is also developing a dry powder inhaler (“DPI”) formulation of ensifentrine.

In the US, DPI/MDI handheld inhalers are the most widely used option for medication in COPD, where an estimated 5.5 million people use inhalers for COPD maintenance therapy.1 This market was valued at approximately $6 billion in 2017.2

The Phase 2 trial using the MDI formulation has a randomized, double-blind, placebo-controlled, two-part design. The Company anticipates reporting data from the first part of the trial in the second half of 2019, with final data expected in the first quarter of 2020.

The first part of the trial will evaluate the PK profile following a single dose of ensifentrine over 5 dose cohorts (100 µg, 300 µg, 1000 µg, 3000 µg, 6000 µg) or placebo. Verona Pharma is aiming to enroll 36 patients with moderate-to-severe COPD at two sites in the UK. The safety, tolerability and the bronchodilation effect of ensifentrine will also be assessed.

The second part of the trial will be conducted as a multiple dose crossover trial. Patients will be randomized to up to 4 dose levels or placebo, with the ensifentrine MDI formulation dosed twice-daily over one week. All patients will receive each of the dose levels and placebo, over the seven-day treatment period. The primary endpoint is based on bronchodilation and will be assessed in terms of peak forced expiratory volume in one second (FEV1), a standard measure of lung function. Secondary objectives of this part of the trial include evaluating the safety, tolerability and the bronchodilator profile as well as the PK profile.

“We are excited to expand the ensifentrine portfolio with the MDI formulation for the treatment of patients with COPD. DPI and MDI inhaler formulations have the potential to expand dramatically the clinical utility and commercial opportunity of ensifentrine in the treatment of COPD. We plan to seek a strategic partner to develop and commercialize inhalers of ensifentrine to maximize the significant potential value from this opportunity.”

Jan-Anders Karlsson, PhD, CEO of Verona Pharma

In addition to advancing the MDI and DPI formulations of ensifentrine into Phase 2 clinical development, Verona Pharma has also developed a nebulized formulation of ensifentrine, which is currently being evaluated in a Phase 2b clinical trial in moderate-to-severe COPD patients designed to inform dose selection for Phase 3 trials planned for 2020.

1 IQVIA Q4 2017

2 Trends in COPD: Morbidity and Mortality, American Lung Association, 2013, Make et al, Intl. Journal of COPD, 2012