Verona Pharma, the UK company focused on the discovery and development of new drugs for chronic respiratory diseases, has applied to the Medicines and Healthcare products Regulatory Agency (MHRA) to start Phase II clinical trials in its home market with RPL554.
Verona’s lead compound is a long-acting inhibitor of phosphodiesterase 3 and phosphodiesterase 4, two enzymes known to play an important role in the development and progression of inflammatory respiratory diseases. RPL554 is in development for the treatment of respiratory diseases including asthma, allergic rhinitis (hayfever) and chronic obstructive pulmonary disease (COPD).
A completed Phase I/IIa clinical trial of RPL554 has shown clear clinical benefits in patients with asthma and allergic rhinitis, Verona noted. The company is carrying out further studies to expand the Phase II data and evaluate the potential of RPL554 in COPD. The precise indication or indications for the planned UK trials have not been disclosed yet.
The UK is “a world centre for respiratory studies and has a wealth of experience and expertise in this area, having been responsible for the introduction of most of the inhaled drugs used in the treatment of asthma and COPD”, noted Professor Michael Walker, chief executive officer of Verona Pharma.
The application to the MHRA “is part of Verona’s strategy to access the best expertise available and to pave the way for ongoing clinical development and commercialisation in key markets”, Walker added. “Approval by the MHRA to conduct UK trials of RPL554 would be an important endorsement of the drug’s potential therapeutic value.”
Verona is still in discussions with a number of potential licensees for RPL554, speculation over which the company sought to dampen with a statement in early January following a sharp rise in its share price.
While these discussions continue, Verona is running further trials “to broaden its knowledge of the therapeutic utility of RPL554 and to progress the RPL554 programme towards commercialisation” it said.
The additional data “will be provided to potential licensees and is expected to add value to the RPL554 licensing package”.
Verona also announced that it had secured ethics approval in Italy to go ahead with an exploratory Phase II trial of RPL554 in COPD patients at the Tor Vergata hospital in Rome.