Verona Pharma revealed the top-line results from its Phase 2a clinical trial, in which RPL554 was dosed in addition to Spiriva, one of the most commonly used drugs to treat chronic obstructive pulmonary disease (COPD). The company said in summary, despite the limited number of patients, the data from this Phase 2a trial showed 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.
Dave Singh, the Principal Investigator in this trial, said that the results from this Phase 2a study showed the very significant improvement in lung function that can be achieved in COPD patients using RPL554 in addition to tiotropium, the most widely used LAMA treatment. “These encouraging results reinforce the potential for RPL554 to provide a meaningful difference in the treatment of COPD patients,” Singh said.
Verona Pharma’s CEO, Jan-Anders Karlsson, said he was pleased for RPL554 showing meaningful improvement in lung function of COPD patients and speeds up onset of action when it is administered as an add-on treatment to one of the most widely prescribed LAMA bronchodilators in these patients.
“LAMAs are the mainstay of all regimens under the GOLD4 treatment guidelines. We observed a clear dose response with the 6 mg dose, achieving statistical significance on all of the primary and secondary endpoints,” he said.
Karlsson added that the findings extend the company’s 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. The company will continue to enroll patients in its Phase 2b study to assess nebulized RPL554 for the maintenance treatment of COPD. Karlsson said that the data from the current study further affirms the company’s belief that RPL554 can become a valuable addition to drugs commonly used by patients with COPD.
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 patients and for the treatment of patients with cystic fibrosis.
In previous clinical trials, RPL554 has been observed to result in bronchodilatory effects when used alone or as an add-on treatment to other COPD bronchodilators. These trials have shown clinically meaningful and statistically significant improvements in lung function when RPL554 is added to two commonly used bronchodilators, as compared to the improvements in lung function when either bronchodilator is administered as a single agent. RPL554 has also shown anti-inflammatory effects in a standard challenge study with COPD-like inflammation in human subjects. In these studies, RPL554 has been well tolerated.