Five European countries have agreed to Verona Pharma’s plan to begin enrolling patients in a Phase 2b clinical trial of RPL554 as a maintenance treatment for chronic obstructive pulmonary disease, or COPD.
The trial will be conducted in the United Kingdom, Germany, Romania, Bulgaria, and the Czech Republic. Verona expects to start it in the third quarter of the year. Results are expected in the second half of 2018.
RPL554 is a first-in-class, inhaled, dual inhibitor of the enzymes phosphodiesterase 3 and 4. It is a bronchodilator, or substance that widens airways to increase oxygen flow to the lungs, and an anti-inflammatory agent.
Verona, which develops respiratory disease therapies, hopes RPL554 can treat cystic fibrosis and asthma as well as COPD.
The double-blind, placebo-controlled, four-week clinical trial will investigate the safety and effectiveness of a nebulized or mist form of RPL554.
Researchers will also see how the 400 patients in the trial respond to different doses of the therapy. The study’s primary objective is to see whether RPL554 improves lung function, compared with a placebo. The yardstick researchers will use is forced expiratory volume in one second, or FEV1. That is the amount of air a person can force out their lungs in a second after taking a deep breath.
“This dose escalation trial directly supports our ongoing development plans for RPL554, and we look forward to enrolling patients in these, and potentially additional countries, subject to further approvals,” Dr. Jan-Anders Karlsson, chief executive officer of Verona Pharma, said in a press release.
“This four-week, 400-patient study is an important step forward in evaluating the potential of RPL554 as a promising first-in-class treatment option for the 210 million people around the world who suffer from COPD on an ongoing basis,” he added.
Earlier this month, Verona, which has a global strategic services agreement with QuintilesIMS, announced the start of a U.S. clinical trial for RPL554. The announcement came after the Food and Drug Administration granted Investigational New Drug status to the therapy. Initial results of the trial are expected in late 2017.
In May 2016, Verona released the results of a Phase 2 clinical trial evaluating RPL554 as a maintenance treatment for COPD. The results showed a statistically significant increase in lung function when patients received RPL554, compared with a placebo.
Another finding was that a combination of RPL554 and either of two standard COPD bronchodilators increased airway widening by up to 60 percent more than the bronchodilators alone. The standard therapies are salbutamol and ipratropium bromide.