Curatis Holding AG (SIX: CURN) and Neupharma Co., Ltd. (“Neupharma”), a Japanese pharmaceutical company specializing in oncology, immunology, pulmonology and cardiology disorders,  announce an exclusive license and development agreement for corticorelin (C-PTBE-01) in Japan.

Under the terms of the agreement, Neupharma will receive exclusive rights to develop and commercialize corticorelin for the treatment of peritumoral brain edema (PTBE) in Japan. PTBE is a tumor-associated condition for which no approved targeted therapies currently exist. Neupharma will finance and conduct a pivotal clinical trial in Japan to support filing for approval in Japan. Curatis will receive upfront and milestone payments for the achievement of regulatory and commercial targets totaling up to CHF 83.5 million, as well as royalties on future sales in Japan of up to 20%.

The agreement stipulates that corticorelin is planned to be introduced in Japan initially for children and adolescents. A meeting with the Japanese drug regulatory authority PMDA to discuss the registration enabling study is planned for summer 2026, and the clinical study is expected to start in 2027.

At the same time, preparatory work for the pivotal Phase 3 study for approval in the US and Europe as well as global partnering activities are proceeding as planned.

Corticorelin / C-PTBE-01

Curatis’ lead product candidate, C-PTBE-01 (corticorelin), is being developed to treat peritumoral brain edema (PTBE). PTBE occurs in association with many primary and metastatic (secondary) brain tumors, often in connection with metastases caused by lung cancer, breast cancer, melanoma and colorectal cancer. PTBE results in impairment of brain function due to the accumulation of extracellular fluid around the tumor and can cause symptoms such as headaches, vomiting and neurological dysfunction such as paralysis, speech disorders, visual problems and altered mental status. Standard of care treatment for PTBE is the use of corticosteroids which frequently have serious side effects such as severe myopathy, impaired glucose metabolism, muscle wasting, abnormal weight gain, osteoporosis, gastritis, gastrointestinal bleeding, hypertension and personality changes. Additionally, corticosteroids can also counteract certain cancer therapies such as chemotherapy or emerging immunotherapies that rely on adequate T-cell functionality which is impaired by corticosteroids.

Corticorelin (hCRH), a 41 amino acid endogenous polypeptide, has demonstrated preclinically (in vivo) the ability to positively impact the blood-brain barrier after a disruption due to the underlying malignant tumor. In two clinical studies in patients with PTBE, corticorelin demonstrated the potential to substantially reduce, or in some cases completely replace, steroid use, which may reduce or avoid the severe glucocorticoid-related side effects and subsequently improve quality of life. In the US alone, more than 150,000 patients suffer from PTBE. The estimate for the potential market opportunities for corticorelin is therefore over USD 1 billion per year. Corticorelin is an investigational drug not approved for therapeutic use in the United States or outside the United States.