Pharmacokinetic clinical study initiated by Verona Pharma

Published: 5-Jun-2017

Verona Pharma initiates US clinical pharmacokinetic study for RPL554 following acceptance of an investigational new drug (IND) application by the US Food and Drug Administration (FDA)

A clinical-stage biopharmaceutical company, Verona Pharma recently initiated a clinical pharmacokinetic trial in the US for the product candidate, RPL554, following the acceptance of an IND application by the US FDA.

Verona Pharma is focused on developing and commercialising innovative therapeutics for the treatment of respiratory diseases with significant unmet medical needs.

The first subjects have been enrolled and dosed in the study.

RPL554 is a first-in-class, inhaled, dual inhibitor of the enzymes phosphodiesterase 3 and 4, designed to have anti-inflammatory, as well as bronchodilator properties.

This study will support further development of RPL554 to address unmet clinical needs in patients suffering from COPD and other debilitating respiratory diseases.

RPL554 is currently in development for the treatment of chronic obstructive pulmonary disease (COPD) and cystic fibrosis (CF).

This complete block two-way crossover trial, will investigate the oral bioavailability and pharmacokinetics (PK) of nebulised RPL554 in 12 healthy volunteers.

The study will also assess the tolerability and safety of single nebulised doses of RPL554. The oral bioavailability examines the potential contribution arising from the absorption of the swallowed portion of a nebulised dose of RPL554 to its systemic bioavailability.

Top-line data is expected in the fourth quarter 2017.

Jan-Anders Karlsson, CEO of Verona Pharma, said: "This study will support further development of RPL554 to address unmet clinical needs in patients suffering from COPD and other debilitating respiratory diseases.”

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