Respiratory diseases biopharmaceutical specialist, Verona Pharma said Tuesday that the U.S. Food and Drug Administration has given the green light for the kick-start of a pharmacokinetic (PK) clinical trial in the U.S. for its RPL554 candidate, with the acceptance of an Investigational New Drug application (IND).
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, currently in development for the treatment of chronic obstructive pulmonary disease and cystic fibrosis.
With the IND effective, the Company plans to initiate a PK clinical trial in the middle of this year in approximately 12 healthy volunteers to determine the oral bioavailability of RPL554, as well as assess the safety and tolerability of the drug, with the results expected in the fourth quarter of 2017.
Jan-Anders Karlsson, PhD, CEO of Verona Pharma. “This important regulatory milestone reinforces Verona Pharma’s commitment to bring a novel therapeutic option with both bronchodilator and anti-inflammatory effects to patients with chronic, debilitating respiratory conditions that are not well treated by existing medicines.”