Xinnate Receives FDA IND Approval Enabling Pivotal Phase 2/3 Study in Epidermolysis Bullosa

Xinnate is taking a major step toward reshaping the treatment landscape for Epidermolysis Bullosa with the FDA’s approval of its IND application for TCP-25 – positioning the company’s lead asset for a pivotal Phase 2/3 program and creating a clear path toward U.S. market entry.

Xinnate today announced that the U.S. Food and Drug Administration (FDA) has approved the Company’s Investigational New Drug (IND) application for TCP-25, a novel topical immunomodulatory peptide being developed for the treatment of Epidermolysis Bullosa (EB)—a severe, debilitating, and currently underserved rare disease. This key regulatory milestone enables the initiation of The STEP study, a pivotal Phase 2/3 clinical program designed to evaluate TCP-25 in patients with dystrophic and junctional EB.

“The opening of the IND for TCP-25 is a validation of our data package and represents a major milestone in Xinnate’s clinical development strategy, significantly strengthening our regulatory position in the U.S. market,” said Helene Hartman, CEO of Xinnate.

The STEP study is a placebo-controlled, randomized, multi-center trial that will enroll patients across Europe and the United States. The program is fully funded, with topline results expected in the first half of 2027.

Backed by FDA input, the STEP study has been strategically designed to potentially support a future market-approval pathway, positioning TCP-25 as a potential first-in-class, patient-friendly topical immunomodulator for EB. This regulatory clarity, combined with the program’s advanced stage and robust mechanistic rationale, underscores Xinnate’s momentum as it moves toward late-stage development.

With the IND now open, Xinnate is actively engaging with commercial partners and investors to accelerate global development and maximize the commercial potential of TCP-25 within the rare-disease and dermatology markets.