Verona Pharma starts Phase II of MDI-delivered ensifentrine in COPD
Verona Pharma, the dual AIM (VRP) and Nasdaq (VRNA)-listed biotech specialising in respiratory disease, has started a Phase II dose-ranging trial of a metered-dose inhaler (MDI) formulation of its lead product ensifentrine in moderate-to-severe chronic obstructive pulmonary disease (COPD). The trial is randomised, double-blind and placebo-controlled and has a two-part design.
The first part of the trial will evaluate the pharmacokinetic profile following a single dose of ensifentrine, a PDE3/4 inhibitor, over five doses (100µg, 300µg, 1000µg, 3000µg, 6000µg) or placebo. Verona is aiming to enroll 36 patients and expects to reporting these data in the second half of 2019. The second part of the trial will be conducted as a multiple dose crossover in which patients will be randomised to up to four dose levels of the ensifentrine MDI (dosed twice-daily) or placebo 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. The final data expected in the first quarter of 2020.
Verona has to date conducted studies of ensifentrine using a nebuliser form of ensifentrine. It recently presented resutls from a four-week, 400-patient Phase 2b study at the American Thoracic Society (ATS) conference (these data were initially reported in March 2018). Details of the expanded analysis are available here. The abstract and details are available on the ATS website.
Ensifentrine is also being evaluated in a further Phase IIb trial as an add-on to standard therapy for the maintenance treatment of COPD, with data anticipated around year-end. This is expected to inform the dose selection for Phase III trials. Verona expects to hold an end-of-Phase 2 meeting with the FDA in the first half of 2020 and hopes to start Phase III in the second half of that year.
Verona has a market cap of £62m and reported cash of £54m as of March 31st, hence its technology value is just £8m.