FDA Confirms Type B Meeting on Corticorelin Pivotal Phase 3 Study

MEDIA RELEASE

Liestal, Switzerland– Curatis Holding AG (SIX: CURN) – July 31, 2025. The U.S. Food and Drug Administration (FDA) have agreed to a Type B meeting in Q3 2025 to review the Phase 3 clinical development plan for corticorelin, a novel investigational biologic in development to treat Peritumoral Brain Edema (PTBE).

The meeting aims to achieve alignment on the design of a pivotal Phase 3 clinical trial for corticorelin, planned for initiation in 2026, as well as on key non-clinical and manufacturing aspects.

“This meeting is a critical step forward in advancing the development of corticorelin to  substantially reduce steroid-use in PTBE patients and thereby demonstrate an impact on clinically meaningful endpoints,” said Dr. Roland Rutschmann, CEO of Curatis. “We are committed to completing development and delivering this novel treatment to address a major unmet need.”

About Corticorelin (C-PTBE-01)

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. 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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