Enrollment for Phase 2b Trial of Verona’s COPD Therapy RPL554 Is Ahead of Schedule

Alice Melão, MSc avatar

by Alice Melão, MSc |

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RPL554 Phase 2b trial

Verona Pharma has enrolled more than half of the 400 COPD patients it is seeking for a Phase 2b clinical trial of its therapy candidate RPL554, putting the program ahead of schedule.

This means the company may be able to report the results of the study by mid-2018, sooner than expected. The trial is evaluating RPL554 as a maintenance treatment for chronic obstructive pulmonary disease.

“We are pleased to be making excellent progress in this important study,” Dr. Jan-Anders Karlsson, Verona’s CEO, said in a press release. “We are on track to complete enrollment faster than our original timeline, and are confident of now reporting top-line data in mid-2018, sooner than our previous guidance” of the second half of 2018.

RPL554 is an inhalant designed to inhibit two enzymes associated with COPD, PDE3 and PDE4. It is different from other therapies because it has both anti-inflammatory and bronchodilator properties. A bronchodilator opens airway passages so people can breathe easier.

Verona is conducting clinical trials of RPL554 for cystic fibrosis as well as COPD.

A Phase 2a trial (NCT03028142/2016-004450-15) showed that RPL554, either alone or in combination with Spiriva (tiotropium), opened COPD patients’ airways, improved their lung function, and reduced their inflammation. Spiriva is made jointly by Boehringer Ingelheim Pharmaceuticals and Pfizer.

Verona started the Phase 2b trial (2016-005205-40) in July 2017. It is evaluating the safety and effectiveness of RPL554 as a maintenance therapy for people with moderate to severe COPD. The company is conducting the study at several sites in Europe.

Patients are receiving one of four doses of RPL554 or a placebo twice a day for up to four weeks. They must stop using other long-lasting bronchodilators during the trial.

The primary goal of the study is to assess RLP554’s effect on lung function. The yardstick that researchers are using is FEV1, the amount of air a person can force from their lungs in a second.

Researchers are also looking at whether RPL554 can reduce patients’ COPD symptoms, breathlessness, and need for additional therapies.