Asahi Kasei Starts Phase II Trial of Cresemba in Children in Japan

Study Will Evaluate Isavuconazonium Sulfate in Pediatric Patients

Asahi Kasei Therapeutics Corp. has started a Phase II clinical trial in Japan to evaluate isavuconazonium sulfate, sold under the brand name Cresemba, in children.

The study is being conducted in pediatric patients who are at least 1 year old and under 18 years of age.

Isavuconazonium sulfate is an antifungal medicine used to treat serious fungal infections. In Japan, Cresemba is currently approved for adults, but it is not yet approved for pediatric use.

The new Phase II trial will look at the safety and pharmacokinetics of the medicine in children who are at risk of developing deep fungal infections.

Why Pediatric Fungal Infections Need More Treatment Options

Invasive fungal infections mainly affect people whose immune systems are weakened.

These infections can become serious and may lead to severe health problems if they are not identified and treated quickly.

Children can face an additional challenge because fewer antifungal treatment options are available for pediatric patients.

This has created an unmet medical need for medicines that can be safely and effectively used in children.

Cresemba has already been approved for pediatric indications in several countries. However, pediatric use has not yet been approved in Japan.

Asahi Kasei Therapeutics is now studying the medicine in Japanese children following discussions with the country's regulatory authorities.

What Will the Phase II Trial Study?

The Phase II study is designed to evaluate the safety of isavuconazonium sulfate in children who are at risk of deep fungal infections.

Researchers will also study the pharmacokinetics of the medicine.

Pharmacokinetics, often shortened to PK, means studying what happens to a medicine after it enters the body. This includes how the medicine is absorbed, distributed, processed and removed from the body.

This information is particularly important when developing medicines for children because drug exposure can differ depending on age and body size.

The trial will provide additional information that can help determine how isavuconazonium sulfate performs in Japanese pediatric patients.

What Is Cresemba?

Cresemba is the brand name for isavuconazonium sulfate, an antifungal medicine.

It was originally developed as a new antifungal treatment by Basilea Pharmaceutica International Ltd., a pharmaceutical company based in Switzerland.

Asahi Kasei Therapeutics obtained exclusive rights to develop and commercialize isavuconazonium sulfate in Japan in September 2016.

The medicine is intended to treat serious fungal infections, including aspergillosis, mucormycosis and cryptococcosis.

Cresemba Is Already Approved for Adults in Japan

Cresemba has been available for adult patients in Japan since its approval in December 2022.

At that time, Japanese regulators approved Cresemba Capsule 100 mg and Cresemba Intravenous Infusion 200 mg for the treatment of aspergillosis, mucormycosis and cryptococcosis in adults.

Asahi Kasei later expanded the product's formulation options.

In September 2024, Cresemba Capsule 40 mg received approval in Japan as an additional formulation.

The new pediatric Phase II program is intended to evaluate whether the medicine can also be used for children who face a risk of serious fungal infections.

Why Isavuconazonium Sulfate Is Being Studied in Children

A medicine that is approved for adults cannot automatically be assumed to work in children in the same way.

Children's bodies can process medicines differently, particularly across different age groups.

For this reason, clinical studies are needed to collect pediatric-specific information about safety, drug exposure and appropriate use.

The Phase II trial will provide data on how isavuconazonium sulfate behaves in children in Japan.

The study is being conducted in patients considered to be at risk from deep mycoses, another term used for serious fungal infections affecting deeper tissues or organs.

Asahi Kasei Sees Cresemba as an Important Infectious Disease Product

Asahi Kasei Therapeutics President Daisuke Okajima said Cresemba is an important product within the company's focus on severe infectious diseases.

He noted that fungal infections can lead to serious clinical outcomes and that treatment options for pediatric patients in Japan remain limited.

The company said the pediatric development program is intended to help address this unmet medical need and potentially make another treatment option available to Japanese children.

Asahi Kasei Is Expanding Its Pharmaceutical Business

The development of Cresemba for pediatric patients also fits into Asahi Kasei's wider pharmaceutical strategy.

Pharmaceuticals has been identified as a First Priority business in Asahi Kasei's medium-term management plan.

The company sees pharmaceuticals as an important area for future growth and is continuing to develop differentiated medicines and pipeline products.

The pediatric development of Cresemba is part of this broader focus on developing medicines for patients who may have limited treatment options.

Asahi Kasei and Basilea Have a Long-Standing Product Relationship

The development of Cresemba in Japan began after Asahi Kasei Therapeutics obtained exclusive development and commercialization rights from Basilea Pharmaceutica in 2016.

Since then, the medicine has moved through development and regulatory approval in Japan.

The adult approvals in 2022 and 2024 expanded the availability of Cresemba in the country.

The new Phase II study now represents another step in the development of the medicine for the Japanese market, this time focusing on pediatric patients.

What Happens Next?

The Phase II trial will continue to collect safety and pharmacokinetic data from pediatric patients between 1 and under 18 years of age.

The results will help Asahi Kasei Therapeutics understand the use of isavuconazonium sulfate in Japanese children and provide information for future regulatory discussions.

The company will use the clinical data to determine the next steps for the pediatric development of Cresemba in Japan.

Further development could potentially expand the use of the medicine beyond its current adult indication in the country.

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