Asahi Kasei Pharma has started enrolling patients in a Phase III trial of isavuconazole to treat deep-seated mycosis, comprised of invasive aspergillosis, chronic pulmonary aspergillosis, mucormycosis and cryptococcosis.
The randomised, multi-centre trial is designed to evaluate the safety and efficacy of intravenously (i.v.) or orally administered isavuconazole versus i.v. or oral voriconazole as an active comparator in the treatment of patients with deep-seated mycosis.
It aims to enrol around 100 adult patients in Japan.
Part of an abbreviated development programme, the trial is the result of a licence agreement signed between Asahi Kasei Pharma and Switzerland’s Basilea Pharmaceutica International in 2016.
The agreement gives Asahi Kasei Pharma exclusive rights to develop and commercialse Basilea’s isavuconazole in Japan.
Depending on the successful completion of the Phase III trial, Asahi Kasei Pharma plans to submit a marketing authorisation application for isavuconazole in Japan.
Basilea Pharmaceutica CEO Ronald Scott said: “Invasive fungal infections can be life-threatening and are an area of significant medical need worldwide.
“Basilea is working together with its partners to bring isavuconazole to patients around the world.”
Isavuconazole is an oral azole antifungal, commercialised under the brand name of Cresemba.
The drug is currently available under various licence and distribution agreements in the US, Europe, China, Japan, Latin America, Canada, Russia, Turkey, Israel, the Asia-Pacific, Middle East and North Africa regions.
In the US, isavuconazole is approved for the treatment of patients aged 18 and older for invasive aspergillosis and invasive mucormycosis. However, it is not approved for commercial use outside the US and Europe.