Verona Pharma, a biopharmaceutical company developing therapeutics for the treatment of respiratory diseases, recently announced the initiation of a clinical trial in the United States for its product RPL554. The drug is currently in development for patients with chronic obstructive pulmonary disease (COPD) and cystic fibrosis (CF).
Announcement of the clinical trial follows the recent acceptance of RPL554 by the U.S. Food and Drug Administration (FDA) as an investigational new drug (IND).
The medication, a first-in-class inhaled dual-inhibitor, is designed to target the enzymes phosphodiesterase 3 and 4 which are believed to be associated with pulmonary inflammation. In addition to its reported anti-inflammatory effect, RPL554 also functions as a bronchodilator.
Both COPD and CF are pulmonary diseases associated with obstruction of the airways and a decreased ability to exhale, leading to shortness of breath, hypoxia (low levels of oxygen), and an increased risk of infection. Obstructive lung disease is associated with significant mortality and morbidity in the U.S.
The clinical trial, which recently enrolled its first participants, will investigate the oral bioavailability of the medication, as well as its pharmacokinetic properties in 12 healthy volunteers. Bioavailability and pharmacokinetics refer to the absorption of the medication in the body, as well as how the medication is distributed, metabolized and excreted.
The study also seeks to assess the tolerability and safety profile of a single nebulized dose of RPL554, in addition to the oral bioavailability and potential contributory effects arising from the swallowed portion of a nebulized dose of the medication.
“We are pleased that the IND for RPL554 has been accepted by the FDA and to initiate clinical studies with RPL554 in the United States” Jan-Anders Karlsson, PhD, CEO of Verona Pharma, said in a press release. “This study will support further development of RPL554 to address unmet clinical needs in patients suffering from COPD and other debilitating respiratory diseases.”
Verona Pharma states that initial data from the clinical trial is expected in late 2017.
In addition to the treatment of COPD and CF, the company reported that RPL554 also may have the potential to benefit to patients with asthma. The company said it also is developing different formulations of RPL554 for the treatment of several respiratory conditions.