Verona Pharma plc has signed a contract with the Medicines Evaluation Unit (MEU) in Manchester, UK to undertake a Phase II clinical trial to demonstrate the anti-inflammatory effects of RPL554 with respect to chronic obstructive pulmonary disease (COPD).
The trial, being led by Professor Dave Singh, is designed as a randomized, double-blind, placebo-controlled crossover study in healthy volunteers who will have their airways exposed to an inflammatory stimulus which causes the infiltration of specific cells resulting in inflammation.
Patients will then be treated using 6 repeated daily doses of RPL554 via a nebulizer inhaler, with the primary endpoint being the reduction of inflammation.
This is a standard clinical test used and recognized by big pharma to evaluate the potential anti-inflammatory effects of a drug in the treatment of COPD.
The trial is planned to start within the next couple of months following necessary ethical and regulatory approvals. The preliminary results from the trial are expected in Q4 this year.
This clinical trial follows earlier work to test the anti-inflammatory actions of RPL554, including preclinical studies and a pilot nasal study in humans performed as part of the initial Phase I/IIa clinical trial with RPL554.
Michael Walker, CEO of Verona Pharma, said: “The fundraising completed in January this year has enabled us to initiate this important trial to show that RPL554 is anti-inflammatory. We have already demonstrated that this drug is a bronchodilator i.e. dilates the airways, enabling patients to breathe more easily. If we can demonstrate there is also a combined anti-inflammatory action, this would place RPL554 in a completely new class of therapy for COPD and asthma sufferers.”
He added: “Our objective continues to be to appoint a partner to develop RPL554 into a marketed medicine. The results from this trial will provide further useful and important data for this purpose”.