Global strategic services agreement for lead compound RPL554.
The London-based clinical-stage biopharmaceutical firm, Verona Pharma, has entered into a global strategic services agreement with global contract research organization QuintilesIMS. Under this agreement, QuintilesIMS will serve as the sole provider of core clinical trial services for Verona Pharma’s lead candidate, RPL554.
RPL554 is in development for the maintenance treatment of chronic obstructive pulmonary disease (COPD), as an add-on to commonly used therapies for the treatment of hospital patients with acute exacerbations of COPD and for cystic fibrosis (CF). Verona CEO Dr. Jan-Anders Karlsson said that the agreement “will enhance the agility, productivity and commercial viability” of development activities as they progress to larger-scale clinical trials.
Full terms of the agreement were not disclosed but it is known that Verona will have full access to QuintilesIMS’s therapeutic and operational experts throughout each trial, from planning and design through to execution, as well as to QuintilesIMS's global commercial insights when developing a future market access strategy in the U.S. The two companies have established joint governance and quality oversight in order to ensure that strategic and operational goals are met and that regulatory and quality requirements are complied with.
Taken by inhalation, RPL554 is a dual inhibitor of the phosphodiesterase 3 (PDE3) and phosphodiesterase 4 (PDE4) enzymes. It acts as both a bronchodilator and an anti-inflammatory agent in a single compound. This makes it very different to the corticosteroids, beta2-agonists and anti-muscarinics that are currently used to treat COPD. According to Verona, this is “a unique, dual mechanism of action unlike any other type of drug currently available or in development for respiratory diseases.” with the potential “to benefit patients not satisfactorily treated with existing medicines.”
RPL554 has won Verona ‘Venture & Innovation’ awards from the Cystic Fibrosis Trust, UK, to continue its study in models of CF. To date, these have enabled the company to demonstrate that RPL554 also activates the CF trans-membrane conductance regulator, the protein behind the genetic defect in CF, which helps to reduce mucous viscosity and improving mucociliary clearance.
RPL554 is seen as an attractive alternative to existing PDE4 inhibitors for COPD, asthma and other indications, which have generally been plagued by unpleasant side effects, like nausea, vomiting and weight loss. By contrast, RPL554 has a distinct chemical structure to other PDE4 inhibitors, has high selectivity for PDE3 and PDE4 over other enzymes and receptors and is delivered directly to the lung by inhalation, thereby maximizing pulmonary exposure to it while minimizing systemic distribution and potential adverse events.
The announcement came shortly after Verona Pharma’s annual general meeting, during which shareholders agreed by an overwhelming majority to consolidate the share capital. Within a week, the company applied to join the Alternative Investment Market of the London Stock Exchange. Trading in consolidated ordinary shares began on February 13th, under the new ISIN of GB00BYW2KH80 and a new SEDOL number of BYW2KH8.
