Japanese subsidiary of the Sosei Group, Sosei Co, has commenced a Phase III study of an antifungal agent, SO-1105, for the treatment of oropharyngeal candidiasis caused by Candida species.
The open-label, randomised, multiple centre study with parallel-group design is designed to evaluate the efficacy and safety of SO-1105, with open active comparator miconazole gel.
Sosei Group CEO Shinichi Tamura said; "This is an important step forward in development of SO-1105. With its once-daily mucoadhesive administration, SO-1105 is expected to improve compliance and patients' quality of life."
The company believes that the antifungal agent has the potential to become the first long-acting, sustained-release treatment available in the form of a tablet.
France-based BioAlliance Pharma originally developed SO-1105, which is administered as a muco-adhesive buccal tablet against oropharyngeal candidiasis in immunocompromised patients.
Since obtaining its first marketing authorisation in France in October 2006, SO-1105 has been registered across 24 European countries, in South Korea and in the US, under the trade names Loramyc and Oravig.