Sosei Group, a biopharmaceutical company, has announced the completion of a Phase 1 study of SO-1105 for the treatment of oropharyngeal candidiasis, by its wholly owned Japanese subsidiary, Sosei Co., Ltd.
The clinical study, which was designed to evaluate the pharmacokinetics and safety of SO-1105 in healthy Japanese adults, was conducted in a single study centre in Japan.
Sosei Group CEO, Shinichi Tamura, said: "This is an important step forward in the development of SO-1105. We will continue our efforts to bring this widely used drug to the Japanese market as quickly as possible."
The once-daily, mucoadhesive buccal tablet containing 50mg of miconazole administered to the buccal mucosa in 12 healthy volunteers provided a 24-hour, sustained high-concentration in saliva and on the infection site.
With low plasma concentration, no serious systemic adverse events can be expected.
The Phase 1 study results even demonstrated that SO-1105 had a good overall safety profile, and the usability and compliance were also good.
According to the company, SO-1105 has the potential to become the long-acting, sustained-release treatment in tablet form for oropharyngeal candidiasis in Japan that could enhance patients’ compliance and quality of life.
Oropharyngeal candidiasis is commonly found in immunocompromised patients, including HIV and cancer patients, and in other chronic disease states such as diabetes.
SO-1105, which was originally developed by BioAlliance Pharma, a French pharmaceutical company, first gained marketing authorisation in October 2006.
SO-1105 has since been registered in 26 European countries, in South Korea, and in the US, under the trade names Loramyc / Oravig.