Verona Pharma plc Announces Completion of Patient Enrolment in RPL554 PhIIa Studies
Nov 5 15
Verona Pharma plc announced it has completed patient enrolment for the Phase IIa dose-finding study of RPL554 in asthma and the Phase IIa combination study of RPL554 in chronic obstructive pulmonary disease (COPD), in which the drug is being administered in addition to standard of care bronchodilators. Headline data is expected First Quarter 2016 for the asthma study and Second Quarter 2016 for the COPD combination study. RPL554 is a novel inhaled PDE3/PDE4 inhibitor with anti-inflammatory as well as bronchodilatory properties, currently in development as a nebulised treatment for acute exacerbations in COPD patients in a hospital or home-care setting. The nebulised bronchodilator market was worth approximately $1 billion in 2014 in the US.
Verona Pharma Kicks Off Phase IIa Trial of RPL554 as Part of COPD Combination Therapy
Oct 14 15
Verona Pharma Plc announced that it had commenced dosing in a Phase IIa trial evaluating its inhaled PDE3/PDE4 inhibitor RPL554 as an adjunct to standard reliever therapies in patients with chronic obstructive pulmonary disease (COPD). Verona Pharma plans to enroll up to 30 subjects for the study, which will seek to determine if RPL554 produces an additive bronchodilator effect when administered alongside standard of care bronchodilators in COPD patients. The company expects to report headline results from the combination study in the second quarter of 2016.
Verona Pharma plc Announces Positive Headline Data from RPL554 Study
Sep 29 15
Verona Pharma plc announced encouraging positive headline data of the third and final part (part C) of a randomized, double blind, placebo controlled Single Ascending Dose (SAD) /Multiple Ascending Dose (MAD) clinical study in stable chronic obstructive pulmonary disease (COPD) patients. This study uses a new proprietary and commercially scalable nebulised suspension formulation of the Company's lead pipeline drug, RPL554.1,2 The primary objective of this part of the study was to show the safety and tolerability of the new drug formulation in stable COPD patients with moderate severity of disease. Measurement of lung function using FEV14 was included. Evaluation of the full data set is ongoing and will be presented in an appropriate scientific, peer-reviewed forum at a later date. In the third part of the trial, nebulised RPL554, a novel dual PDE3/PDE4 inhibitor, was administered twice daily using a new proprietary, commercially scalable, suspension formulation to stable COPD patients with moderate disease severity for up to five-and-a-half consecutive days at doses significantly in excess of the previously used active dose. Patients withheld their regular bronchodilator therapy for the duration of the treatment phase of the study. The study met its primary objective and all doses of RPL554 were found to be well tolerated. As with earlier parts of the trial, which were conducted in healthy volunteers, there were no reports of serious adverse events and the adverse event profile was similar to that seen with placebo. In particular, there was an absence of gastro-intestinal or cardiovascular adverse events. Lung function, as measured by peak FEV1, was increased in all dose groups and ranged between 199-257ml over placebo suggesting a clinically meaningful bronchodilator effect which will be confirmed in Phase IIb studies. In the high dose there was a small increase in heart rate as might be expected from the pharmacology of the product. The new commercially scalable formulation of RPL554 results in a uniform suspension of RPL554 and was designed to provide improved tolerability, allowing higher doses of RPL554 to be inhaled, yielding an optimized bronchodilator effect than with the previous prototype, solution formulation. Additionally the new formulation offers potential for improvements in convenience and compliance. Data to date supports this profile, suggesting a twice daily dosing regimen and is consistent with a longer residence time of the drug in lung tissue and slower release into the blood than with the original formulation. In addition, the commercial viability of the new formulation is underlined by significantly improved stability compared to the previous formulation.