Commencement of New Phase II Clinical Trial of RPL554 in Asthma
First patient treated in repeat dosing trial in the Netherlands
Verona Pharma plc (AIM: VRP.L), the biotechnology company focused on discovering new drugs for the treatment of chronic respiratory diseases, has commenced a new trial with its lead respiratory drug, RPL554, at the Centre for Human Drug Research (“CHDR”) in the Netherlands. Verona has treated its first patient in this Phase II clinical trial which is designed to determine whether RPL554 has sustained bronchodilator actions, and is safe when given daily to patients with mild asthma. This trial is a necessary preliminary trial prior to performing a complete and thorough assessment of the anti-inflammatory actions of the drug in terms of reducing the effects of allergen challenge in patients with allergic asthma. This allergen challenge trial is scheduled for later in 2011.
This study into whether RPL554’s bronchodilator actions can be safely sustained over several days of treatment extends the Company’s knowledge of the drug and is the third trial with RPL554 in patients with allergic asthma. The second trial, recently completed at the CHDR (February 2011), established the effectiveness of higher doses of the drug.
The key measurement that will be performed in the trial is the standard measure of FEV1 (Forced Expiratory Volume in 1 sec) to test the effect of RPL554 on lung function. Cardiovascular safety and gastrointestinal tolerance will also be assessed. The drug will be given in the same nebulized form as in the previous clinical trials.
Professor Michael Walker, CEO of Verona Pharma, said: “This trial, which has just started, will test the therapeutic usefulness of RPL554 when given over a period of days, reflecting the manner in which the drug will eventually be used medically. All the evidence we have accumulated so far with RPL554 strengthens the view that it is the first drug in a significant new class of bronchodilator with possible combined anti-inflammatory actions. While licensing efforts for RPL554 continue, the Company is performing further clinical trials to broaden its knowledge of the therapeutic utility of RPL554 and, of course, add value in terms of licensing.”
The RPL554 compound is a novel long acting bronchodilator/anti-inflammatory drug belonging to a class of drugs known as a mixed phosphodiesterase (PDE) 3/4 inhibitor. Verona is investigating its use for the treatment of respiratory diseases including asthma, chronic obstructive pulmonary disease (COPD) and allergic rhinitis (hay fever).