Verona Pharma plc, a company with a focus on first-in-class drugs for the treatment of respiratory diseases, recently announced that the first patient was dosed in its Phase IIa combination clinical study examining the addition of RPL554 to standard reliever drugs for patients with chronic obstructive pulmonary disease (COPD).
RPL554 is a new inhaled PDE3/PDE4 inhibitor with bronchodilatory and anti-inflammatory properties that is being developed as a nebulized therapy for acute exacerbations in patients with COPD in home or hospital-care settings. In the United States in 2014, the market for nebulized bronchodilators was worth about $1 billion.
The study’s primary endpoint is to assess whether RPL554 is able to provide an additive bronchodilator effect when given to COPD patients in addition to conventional bronchodilators. The placebo-controlled, double-blind, six-way crossover study is aiming to enroll up to 30 COPD patients and will explore the pharmacodynamic effect of RPL554 in a commercially ascendable suspension preparation.
To compare RPL554 to placebo when given to patients with a beta2 agonist (salbutamol) and a muscarinic antagonist (ipratropium), the trial will use whole body plethysmography and spirometry. Lead investigator Professor Dave Singh is conducting the study at the Medicines Evaluation Unit in Manchester.
As stated on September 29th, results from a previous Phase IIa study where moderate COPD patients were administered RPL554 revealed that the nebulizer demonstrated a good safety and tolerability profile and was able to improve lung function as assessed by peak FEV1, indicating that the drug had a clinically meaningful bronchodilator effect.
Dr. Jan-Anders Karlsson, the CEO of Verona Pharma, said: “We believe RPL554 has the potential to become an important new treatment option for COPD patients. This latest study will evaluate the potential of RPL554 when added to existing therapies. We recently announced encouraging results from our standalone Phase IIa study, which demonstrated that the new commercially scalable, suspension formulation of RPL554 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. Headline data from this combination study is expected in Q2 2016. “We are also evaluating the potential of RPL554 in a Phase IIa trial in asthma patients and look forward to reporting headline data in Q1 next year.”
COPD, or chronic obstructive pulmonary disease, is a progressive disease that makes it hard for patients to breathe. “Progressive” means the disease gets worse over time. COPD can cause coughing that produces large amounts of mucus (a slimy substance), wheezing, shortness of breath, chest tightness, and other symptoms. Cigarette smoking is the leading cause of COPD. Most people who have COPD smoke or used to smoke. Long-term exposure to other lung irritants — such as air pollution, chemical fumes, or dust—also may contribute to COPD.
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