According to Verona Pharma’s mid-year update, the company is developing MDI and DPI formulations of its RPL554, an inhaled PDE3/PDE4 inhibitor. Nebulized RPL554 is currently in Phase 2 development, and Verona reported positive results from a Phase 2a trial of RPL554 for the treatment of acute exacerbations in COPD patients in March 2016.
The company said that it has initiated a Phase 2b dose-ranging trial of nebulized RPL554 for the maintenance treatment of COPD in Europe within the past 6 months and expects to report top line data in the second half of 2018. A Phase 2a trial of RPL554 as an add-on to tiotropium for COPD is also underway, with top line data expected by the end of this year.
The update also noted 2 other trials that began in the first half of this year: a now-completed Phase 1 PK trial and a Phase 2 PK/PD trial in cystic fibrosis patients.
In addition, the company said that Quintiles IMS will serve as the sole provider of clinical trial services for the RPL554 development program. Verona also noted that it is now trading on the NASDAQ and had raised $90 million gross through its initial public offering, as well as private placements.
Verona CEO Jan-Anders Karlsson commented, “It has been a transformative six months for Verona Pharma. Not only have we successfully completed our IPO of ADSs on NASDAQ, but we have also commenced four clinical trials with our lead candidate RPL554, including our first clinical study in the United States following FDA acceptance of our IND application and have continued to expand our senior management. 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, as well as for the treatment of acute exacerbations of COPD. 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.”
Read the Verona Pharma press release.