Xinnate announces successful FDA meeting for TCP-25

Helene Hartman, CEO of Xinnate AB

Lund, Sweden – Xinnate AB, a clinical-stage company focused on developing treatments for patients with Epidermolysis Bullosa (EB), today announced that positive feedback from its Type C meeting with the U.S. Food and Drug Administration (FDA), Division of Dermatology and Dentistry, in the Office of Immunology and Inflammation. As a result, of the meeting the upcoming study is now being upgraded to serve as a registrational trial.

“We are grateful that we have FDA’s support for the development program of the drug candidate TCP-25 and the upcoming clinical trial”, says Helene Hartman, CEO of Xinnate. FDA acknowledged the unmet medical need in the EB population and provided valuable input to the study design which would allow the study to be upgraded to serve as the basis of registration upon successful completion.

The clinical trial, which is named the STEP trial, is an international multicenter, randomized, double-blind, placebo controlled study designed to assess the efficacy and safety of TCP-25 in patients with dystrophic and junctional EB. The STEP trial is planned to start during 2025.

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. Earlier this year the US Food and Drug Administration (FDA) granted Orphan Drug Designation (ODD) for the company’s drug candidate TCP-25 for the treatment of the severe disease Epidermolysis Bullosa (EB). 

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 clinical phase 2/3 STEP study is planned to start during 2025.

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