Curatis Holding and Japanese pharmaceutical company Neupharma have announced a landmark exclusive license and development agreement for corticorelin in Japan, targeting a condition with no approved therapies.

 

Under the deal, Neupharma gains exclusive rights to develop and commercialize corticorelin for peritumoral brain edema (PTBE), a tumor-associated condition. Neupharma will fund and conduct a pivotal clinical trial in Japan to support regulatory approval, while Curatis stands to receive upfront and milestone payments totaling up to CHF 83.5 million, plus royalties of up to 20% on future Japanese sales.

 

The agreement specifies that corticorelin will initially be introduced 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,” the companies said.

 

Preparations are also underway for the pivotal Phase 3 study targeting approval in the US and Europe, with global partnering activities proceeding as planned.

 

Curatis’ lead candidate, corticorelin, is designed to treat PTBE, which frequently occurs alongside primary and metastatic brain tumors. Symptoms include headaches, vomiting, and neurological dysfunction such as paralysis, speech disorders, visual problems, and altered mental status. 

 

Current standard-of-care corticosteroids can have severe side effects, including “severe myopathy, impaired glucose metabolism, muscle wasting, abnormal weight gain, osteoporosis, gastritis, gastrointestinal bleeding, hypertension and personality changes,” and may interfere with chemotherapy or immunotherapies.

 

Corticorelin, a 41 amino acid endogenous polypeptide, has shown in preclinical studies the ability to repair the blood-brain barrier disrupted by tumors. 

 

In two clinical studies, 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.”