Curatis: FDA Minutes Confirm Positive Outcome of Meeting on 9. September 2025 – Corticorelin on Track for Phase 3

Curatis Holding AG (SIX:CURN) received the official minutes from the FDA meeting which took place on 9. September. Based on the totality of the feedback and discussions, Curatis can proceed as planned with the clinical development of corticorelin. Corticorelin is under development as a novel treatment intended to reduce or even eliminate steroid use and associated toxicities thereby potentially impacting the quality of life of patients suffering from peritumoral brain edema (PTBE) associated with metastatic (secondary) brain tumors.

The virtual meeting with the FDA provided the opportunity to discuss the clinical development plan for corticorelin and encompassed CMC (Chemistry, Manufacturing and Control), nonclinical and clinical aspects. The offical FDA minutes which Curatis received after publication of the half year results reflect the positive outcome. Curatis may proceed without delay to a regulatory submission supporting a pivotal study in patients suffering from PTBE secondary to solid tumor brain metastases. The Phase 3 will utilize an adaptive trial design consisting of a dose optimization lead-in and confirmatory segment. "This validation of our clinical plans for corticorelin in patients with brain metastases secondary to solid tumors marks a milestone, enabling us to pursue partnering opportunities with global leaders in oncology and specialty care," stated Dr. Roland Rutschmann, CEO of Curatis. "By targeting steroid reduction or even elimination of steroid use in PTBE, we address a critical unmet need, potentially enhancing patient quality of life by mitigating glucocorticoid toxicities."

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, impared 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. In the US alone, more than 150,000 patients suffer from PTBE.

Corticorelin / C-PTBE-01

Curatis’ lead product candidate, C-PTBE-01 (corticorelin), is being developed to significantly reduce or replace steroid use in PTBE patients and demonstrate a positive effect on patient’s quality of life. 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 completely replace steroid use, which may reduce or avoid the severe glucocorticoid-related side effects and subsequently improve quality of life.

Corticorelin is an investigational drug not approved for therapeutic use in the United States or outside the United States.

About Curatis:

Curatis Holding AG is a publicly listed company (CURN.SW) specializing in the late stage development and commercialization of drugs for rare diseases and specialty care. Curatis has a sales portfolio of more than 40 products and a pipeline of orphan and specialty drugs. More information can be found on the website www.curatis.com.

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