A Phase 2 trial demonstrates that maintenance treatment with dry power inhaler (DPI) formulation of ensifentrine (RPL554) is safe and significantly improves lung function in moderate to severe chronic obstructive pulmonary disease (COPD) patients. The clinical trial met its Phase 2 primary and secondary goals, demonstrating that ensifentrine led to meaningful and dose-dependent improvements in lung function while being well-tolerated.
This update was reported by COPD News Today and was based on a Phase 2 study sponsored by Verona Pharma, which evaluated ensifentrine’s safety and efficacy in a two-part Phase 2 trial involving 35 patients with moderate to severe COPD.
Ana Pena of COPD News Today reported that the primary efficacy measure, or endpoint, was met. It turns out ensifentrine had considerable bronchodilator effect as seen as significant increases in peak forced expiratory volume (FEV1) from study start of mL for the 150-ug dose, 175 mL for the 500-ug dose, 180 mL for the 1,500-ug dose, and 260 mL for the 3000-ug dose.
Lead Investigator Comment
Joseph A. Boscia III, MD pulmonary physician and principal investigator at Vitalink Research Union of South Carolina noted “Achieving a bronchodilator response of this magnitude in COPD patients is clinically meaningful and very encouraging.”
About Sponsor: Verona Pharma
Verona Pharma is a clinical stage biopharmaceutical company focused on the development and commercialization of innovative prescription medicines to treat respiratory diseases with significant unmet medical needs, such as COPD, cystic fibrosis and asthma. The company is listed on the Nasdaq Global Market in the United States under VRNA ticker and the London Stock Exchange in the UK under the VRP.L ticker. Based in the UK, they are thinly traded micro-cap.
What is Ensifentrine? (RPL554)
RPL554 (Ensifentrine): Verona describes as their breakthrough lead product, RPL554, is “first-in-class”. It offers a unique dual mechanism of action unlike any other type of drug currently available or in development for respiratory diseases. Uniquely, it combines bronchodilator and anti-inflammatory properties in one compound and has the potential to benefit patients not satisfactorily treated with existing medicines. It has secured the Company Venture and Innovation awards from the Cystic Fibrosis Trust, UK, to continue its study in models of cystic fibrosis. The funds from these awards have enabled Verona to demonstrate that in addition to its bronchodilator and anti-inflammatory properties, RPL554 also activates CFTR, the protein behind the genetic defect in cystic fibrosis. This is just part of the process of building a strong clinical R&D pipeline for more breakthrough, first-in-class drugs to treat respiratory diseases.
Clinical results to date highlight the important potential benefits of this novel dual PDE3/4 inhibitor for the treatment of COPD.
VitalLink, a fully integrated network of clinical trial sites, served as principal investigator to this COPD study. They represent 13 wholly-owned and dedicated research sites, each operating under one brand with unified processes and standard operating procedures.