Verona Pharma Updates Clinical Development of COPD Therapy RPL554

Verona Pharma recently announced clinical development updates and interim results for the first half of 2017 for RPL554 as a treatment for chronic obstructive pulmonary disease (COPD) with the start of four new clinical trials.

Verona developed RPL554 as a nebulized dual-inhibitor of the enzymes phosphodiesterase 3 and 4 (PDE3 and PDE4). The drug has anti-inflammatory and bronchodilator properties. Apart from COPD, the drug is also being tested as a treatment for cystic fibrosis and, potentially, asthma.

According to the company’s report, in the six months of 2017:

• A Phase 2a clinical trial (NCT03028142) was initiated assessing RPL554 as an add-on therapy to Spiriva (tiotropium), a long-acting bronchodilator for the treatment of COPD. Top-line data is expected in late 2017.
• A Phase 1 trial was conducted in the U.S. to study how RPL554 is processed in the body (called pharmacokinetics), following acceptance of an investigational new drug (IND) application by the U.S. Food and Drug Administration (FDA). Top-line data should be available in late 2017.
• Verona obtained approval and commenced a four-week Phase 2b dose-ranging clinical trial in Europe to study the efficacy, safety, and dose-response of RPL554 for the maintenance treatment of COPD. Top-line data is expected in the second half of 2018.
• a Phase 2a clinical study (NCT02919995) was initiated to understand how RPL554 is processed in the body, what are its effects and its mechanism of action. Up to 10 cystic fibrosis patients will be enrolled in the trial. Data is expected in the first half of 2018.

“We now have the team and funding to deliver a comprehensive package of Phase 2b data for nebulized RPL554 as maintenance therapy for both COPD and CF [cystic fibrosis], as well as for the treatment of acute exacerbations of COPD,” Jan-Anders Karlsson, CEO of Verona, said in a press release.

Verona also started the development of RPL554 as two different formulations for the maintenance treatment of COPD — as a dry powder inhaler and a metered dose inhaler.

“We are developing additional formulations of RPL554 that we believe would significantly extend the commercial opportunity in COPD and other respiratory indications. We look forward to updating the market on multiple clinical data points in this and coming years,” Karlsson said.