Verona Pharma’s respiratory drug proves positive in study
pharmafile | October 1, 2015 | News story | Research and Development | COPD, verona pharma
Verona Pharma has announced encouraging positive headline data of the third and final part of a randomised, clinical study in stable chronic obstructive pulmonary disease (COPD) patients.
The primary objective of this part of the study was to show the safety and tolerability of RPL554 in stable COPD patients with moderate severity of disease. Measurement of lung function was included and evaluation of the full data set is ongoing.
Part C of the study in 32 stable COPD patients with moderate disease severity showed the drug formulation was well tolerated at all dose levels with no serious adverse events reported and RPL554 caused pronounced improvement in lung function.
RPL554 is Verona’s lead drug. Delivered via inhaler, it inhibits the phosphodiesterase 3 (PDE3) and phosphodiesterase 4 (PDE4) enzymes, two enzymes known to be of importance in the development and progression of immunological respiratory diseases.
Verona says the drug has the potential to act as both a bronchodilator and an anti-inflammatory, which would significantly differentiate it from existing treatments.
Dr Jan-Anders Karlsson, chief executive of Verona Pharma, says: “We are excited by the robust and consistent results arising from our SAD/MAD study of RPL554 in both healthy volunteers and now, stable COPD patients with moderate disease severity. The data demonstrates that, as designed, the new commercially scalable, suspension formulation is well tolerated and has allowed us to extend the dose range and the duration of bronchodilation effect that can be produced in COPD patients.
“We will now fully analyse the data from this trial. While we need to discuss these results and confirm our further development plans for the drug with the appropriate regulatory authorities, we currently expect to begin Phase IIb studies in the second half of 2016.”
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 highest dose there was a small increase in heart rate as might be expected from the pharmacology of the product.
Professor Dave Singh of the Medicines Evaluation Unit, University of Manchester, lead investigator on this study, says: “I am very encouraged by the headline results of this study using the new suspension formulation of RPL554. The marked improvement in lung function seen in this initial small study shows that this product has potential to be a meaningful addition to existing treatment options for COPD.”
Yasmita Kumar
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