Press release
Aug 29, 2016

Sosei announces completion of Japanese Phase III clinical study of SO-1105 for oropharyngeal candidiasis and achievement of principal endpoints

Tokyo, Japan – 29 August 2016: Sosei Group Corporation (TSE Mothers Index: 4565) hereby announces that its Japanese subsidiary Sosei Co. Ltd. has completed the Japanese Phase III study of SO-1105 (miconazole 50 mg, muco-adhesive tablet) for the treatment of oropharyngeal candidiasis; meeting the primary endpoint as requested for submission.

The study was an open-label, randomized, multi-site, parallel-group, comparative clinical study to investigate the efficacy and safety of SO-1105 in comparison with a commercialized formulation of miconazole in patients with oropharyngeal candidiasis in Japan.

The cure rate after the completion of the targeted study medication period with SO-1105 was the same as the comparator in terms of the primary endpoint. In addition, the primary endpoint in the sub-group analysis (cure rate in post-radiotherapy patients with head-and-neck cancer) was similar to the one from overseas clinical studies with SO-1105 in this population. All other efficacy endpoints demonstrated non-differentiation between SO-1105 and the comparator in the Japanese study as well as overseas. Furthermore, the safety of SO-1105 showed a similar profile to the comparator.

SO-1105 is an antifungal agent administered for the first time in Japan as a once-daily mucoadhesive tablet for the treatment of oropharyngeal candidiasis in immunocompromised patients. It has the potential to offer a new treatment option, as release of the active component is local and sustained thereby increasing the convenience for patients.

Loramyc® (SO-1105 in Japan) was developed by Onxeo SA (referred to hereafter as “Onxeo”), formerly known as BioAlliance Pharma SA. The product is commercialized in the US under the name of Oravig® and in Europe under the name of Loramyc®. The technology used for SO-1105, called Lauriad™, has been developed to provide high concentrations of the active ingredient directly at the site of infection. Sosei Co. Ltd. obtained the exclusive marketing rights for SO-1105 in Japan from Onxeo in May 2011 and has already entered into an exclusive contract for marketing and commercialization with Fujifilm Pharma Co., Ltd.

Sosei Co. Ltd. is currently preparing the application for approval of SO-1105.