Xinnate receives Orphan Drug Designation from US FDA for TCP-25

 

Lund, Sweden – Xinnate AB today announced that 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,” said Helene Hartman, CEO of Xinnate.

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.

The FDA grants OODs to support the development of therapies for rare disorders affecting fewer than 200,000 people in the US. The designation qualifies a company for several benefits, including tax credits, exemptions from certain FDA fees for clinical trials, and seven years of market exclusivity following drug approval.

For more information, please contact:
Helene Hartman, CEO of Xinnate, helene.hartman@xinnate.com, +46725120312

 

About Xinnate AB

Xinnate is a clinical-stage pharmaceutical company pioneering novel therapies based on a proprietary peptide technology. These therapies aim to address dysfunctional healing by targeting the interplay of microbial presence and inflammatory responses. With an ambitious development program, Xinnate is dedicated to transforming the lives of patients with Epidermolysis Bullosa and other inflammatory skin conditions. A three-part Phase 1 study of the first drug candidate, TPC-25 gel, has been completed including a group of patients with Epidermolysis Bullosa. The phase 2 study is planned to start during 2025.

Xinnate is a member for SmiLe Venture Hub at Medicon Village in Lund, Sweden.
www.xinnate.com/

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