Verona COPD drug beats Boehringer blockbuster in phase 2

Verona Pharma has released results showing that adding its RPL554 to Boehringer Ingelheim’s Spiriva improves lung function in chronic obstructive pulmonary disease (COPD) patients. Data from the small phase 2a trial suggest Verona’s PDE3/PDE4 inhibitor may complement long-acting muscarinic antagonist (LAMA) bronchodilators such as Spiriva.

U.K.-based Verona has designed RPL554 to provide bronchodilation and anti-inflammatory effects without the nausea and vomiting associated with earlier PD4 inhibitors. The hope is these characteristics will complement LAMAs and improve outcomes in patients taking the widely used class of medicines.  

Investigators at a single site in the U.K. enrolled 30 patients with moderate-to-severe COPD. All participants received an open-label dose of Spiriva via a dry-powder inhaler followed immediately by one of two doses of RPL554—1.5 mg or 6 mg—or placebo from a nebulizer. Each patient took morning and evening doses of RPL554 or placebo over the next three days. 

Both RPL554 doses beat placebo in terms of peak forced expired volume in 1 second (FEV1) after the third morning dose. Only the higher 6 mg dose bested the average FEV1 achieved by placebo patients.

That dose separation was evident in the secondary endpoints. The 6 mg dose produced a faster onset of action than Spiriva alone and reductions in functional residual capacity and residual volume. The 1.5 mg dose fell short on the residual volume secondary endpoint. 

“We observed a clear dose response with the 6 mg dose,” Verona CEO Jan-Anders Karlsson, Ph.D., said in a statement. “These findings extend our previous data and show that RPL554 has the potential to further improve lung function when administered as an add-on treatment to both short-acting and long-acting bronchodilators ... [and] further affirms our belief that RPL554 can become a valuable addition to drugs commonly used by patients with COPD.”

Verona is planning to further test the idea that RPL554 complements long-acting bronchodilators in a 400-patient phase 2b that is slated to start in the second half of next year. That trial start is one of a slew of milestones penciled in for the next 18 months, a period that covers the readout from a phase 2a trial of RPL554 in patients with cystic fibrosis. 

Shares in Verona rose about 15% in London on news of the phase 2a data.