Asahi Kasei Starts Phase 2 Cresemba Study in Japan

• Asahi Kasei Therapeutics Corp. started a phase 2 clinical study in Japan testing Cresemba in pediatric patients at risk of deep mycoses.
• The study is multicenter, open-label and non-controlled, assessing safety and pharmacokinetics in children.
• Cresemba is approved for adults with severe fungal infections in Japan but not yet for pediatric use there.
• Cresemba is already approved for pediatric use in the US, Canada, Europe and China.
• Cresemba is marketed in more than 70 countries and is the largest branded antifungal for invasive fungal infections worldwide.

Study Launch

Asahi Kasei Therapeutics Corp. started a phase 2 clinical study in Japan for Cresemba, testing isavuconazole in pediatric patients at risk of deep mycoses.

The study is multicenter, open-label and non-controlled, assessing safety and pharmacokinetics of Cresemba in children.

Cresemba is an intravenous and oral azole antifungal with the active ingredient isavuconazole.

Current Approval Status

Cresemba is approved in Japan for adults with severe fungal infections, but not for pediatric patients.

In Japan, isavuconazole is approved for adults with aspergillosis, mucormycosis and cryptococcosis.

Isavuconazole is also approved in the European Union, the United Kingdom, the United States and other countries, including in the Asia Pacific region.

Cresemba is already approved for pediatric use in the US, Canada, Europe and China.

It is marketed in more than 70 countries and holds the position of the largest branded antifungal for invasive fungal infections worldwide.

Disease Background

Deep mycoses are life-threatening fungal infections that spread into deep tissues, including the lung, eyes, brain, bones, bloodstream and other organs.

The disease predominantly affects immunocompromised patients, including those with hematologic malignancies, transplant recipients, or immunodeficiency disorders.

Company Comment

We are very pleased with the start of the pediatric study for Cresemba by our partner Asahi Kasei Therapeutics Corp.. Invasive fungal infections pose a critical threat for children suffering from hematologic malignancies or immunodeficiency disorders. Despite this high-risk setting, treatment options remain limited. Making Cresemba available to pediatric patients in Japan would represent a major advance in addressing this important medical need.

— Dr. Marc Engelhardt, Chief Medical Officer of Basilea

About Basilea

Basilea Pharmaceutica Ltd, headquartered in Allschwil, Switzerland, is a commercial-stage biopharmaceutical company focused on severe bacterial and fungal infections.

Founded in 2000, the company trades on the SIX Swiss Exchange under BSLN.

Basilea has launched two hospital brands, Cresemba for invasive fungal infections and Zevtera for bacterial infections.