Verona presents on Phase 2 trial of potential 1st-in-class COPD med

Verona Pharma plc (NASDAQ: VRNA) today presented Phase 2a and pharmacokinetic data from two clinical trials evaluating its lead product candidate, RPL554, in chronic obstructive pulmonary disease (COPD) at the American Thoracic Society International Conference (ATS 2018), in San Diego. Results from these trials were previously reported by Verona Pharma on September 7, 2017 and September 27, 2017, respectively.

RPL554 is a first-in-class, inhaled, dual inhibitor of the enzymes phosphodiesterase 3 and 4 designed to have anti-inflammatory as well as bronchodilator properties, and is currently in development for the maintenance treatment of COPD and for the treatment of cystic fibrosis.

The poster, titled, “RPL554, A First-In-Class Dual PDE3/4 Inhibitor, Causes Rapid Additional Bronchodilation When Dosed with Tiotropium in COPD Patients,” provided a review of the positive data from Verona Pharma’s Phase 2a clinical trial, in which RPL554 was dosed in addition to tiotropium (Spiriva®), one of the most commonly used drugs to treat COPD. In summary, the data from this Phase 2a trial demonstrated significantly improved peak lung function when RPL554 was added to tiotropium in patients with moderate-to-severe COPD.

This was a double blind, placebo-controlled, three way cross-over trial in 30 subjects with COPD and included two different doses of RPL554, 1.5 mg and 6 mg, or placebo, dosed twice-daily for three days, in addition to tiotropium, a long-acting anti-muscarinic (LAMA) bronchodilator, dosed once-daily (ClinicalTrials.gov Identifier: NCT03028142). The primary outcome measures for the trial were peak forced expired volume in one second (FEV1) on the third day of dosing and the average FEV1 on the third day of dosing, representing measures of lung function and duration of effect. A number of secondary outcome measures were also recorded. Of note, the 6 mg dose of RPL554 achieved statistical significance, compared to placebo, on all primary and secondary outcome measures. The data confirmed dose dependency between the two RPL554 doses.

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