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news.Sosei Co., a wholly owned Japanese subsidiary of Sosei Group, has completed Phase I study of SO-1105, for the treatment of oropharyngeal candidiasis
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The clinical study was designed to evaluate the pharmacokinetics and safety of SO-1105 in healthy Japanese adults.
Sosei Group CEO Shinichi Tamura said, "This is an important step forward in 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 muco-adhesive buccal tablet containing 50mg of miconazole administered to the buccal mucosa in 12 healthy volunteers provided a 24-hours sustained high concentration in saliva and on the infection site.
The results also demonstrated that SO-1105 had a good overall safety profile, and the usability and compliance were 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.