UK-based Verona Pharma says it has initiated preliminary discussions with the European Medicines Agency (EMEA) in an effort to gain approval to conduct clinical trials of its allergic respiratory disease drug candidate RPL554. The firm said that it is in the process of preparing its submission dossier to support the application.
Verona added that RPL554 may represent a real step forward in the treatment of allergic respiratory conditions, including asthma, as it is does not utilize the steroids or beta agonists responsible for the side effects associated with currently-available medications.
The company's chief executive, Michael Walker, said that, while final analysis of toxicology data is yet to be completed, results produced so far suggest that the are no major toxicity issues associated with the drug. If approval is forthcoming, Verona plans to conduct combined Phase I/IIa trials in healthy patients suffering from mild, stable asthma in an effort to further confirm RPL554's safety and efficacy.
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