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Xinnate receives Orphan Drug Designation from the FDA

The US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for the company’s drug candidate TCP-25 for the treatment of the severe disease Epidermolysis Bullosa (EB).
“We are excited about FDA’s decision to grant ODD for TCP-25, recognizing its unique mechanism of action, the robust data generated during preclinical and clinical development and the significant unmet medical needs of patients suffering from EB. This designation underscores the potential of TCP-25 as a transformative treatment option and will facilitate our efforts to bring this therapy to patients who needs it most,” says Helene Hartman, CEO of Xinnate.
An immunomodulatory peptide
TCP-25 is an immunomodulatory peptide being developed by Xinnate for the treatment of the rare, devastating disease EB as well as other conditions involving inflammation and infection in skin and wounds. TCP-25 has demonstrated dual-action capabilities, targeting both inflammation and bacterial infection to promote faster and more effective healing.
Source: SmiLe Incubator
Updated: January 21, 2025, 02:17 pm
Published: January 14, 2025
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