Date: 2011-08-17
Type of information:
phase:
Announcement: completion of the study
Company: Verona Pharma (UK)
Product: RPL554
Action mechanism: RPL554 is a long acting bronchodilator/anti-inflammatory drug belonging to a class of drugs known as a mixed phosphodiesterase (PDE) 3/4 inhibitor. Verona Pharma is investigating its use for the treatment of respiratory diseases including asthma, chronic obstructive pulmonary disease (COPD) and allergic rhinitis (hay fever).
Disease: mild asthma
Therapeutic area: Allergic diseases - Inflammatory diseases - Respiratory diseases
Country:
Trial details:
Latest
news: * On August 17, 2011, Verona Pharma has successfully completed a further Phase II study to test the duration of bronchodilator action with repeated doses of its lead drug, RPL554, in patients with mild asthma. The trial successfully demonstrated that RPL554 had sustained bronchodilator actions throughout the treatment period. There was no accumulation of the drug in plasma and no safety issues were observed. There was a minor increase in heart rate at day 6 only, being the last day of treatment.
This is the third trial with RPL554 in patients with allergic asthma. The second trial, recently completed at the CHDR in February 2011, established the effectiveness of higher doses of the drug. A further trial currently being planned to test the anti-inflammatory actions of RPL554 is expected to start later this year.
* On May 12, 2011, Verona Pharma has commenced a new trial with its lead respiratory drug, RPL554, at the Centre for Human Drug Research (“CHDR”) in the Netherlands. The company 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 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.
