Xinnate Receives FDA IND Approval for TCP-25, Enabling Pivotal Phase 2/3 STEP Study in Epidermolysis Bullosa

Lund, Sweden – 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.

For more information

Helene Hartman, CEO
helene.hartman@xinnate.com

About Xinnate AB

Xinnate is a clinical-stage pharmaceutical company developing next-generation therapies built on proprietary peptide technology designed to restore balance in dysfunctional wound healing. By targeting the critical interplay between microbial triggers and inflammatory responses, Xinnate aims to deliver transformative treatments for Epidermolysis Bullosa (EB) and other inflammatory skin disorders with high unmet medical need. The company has completed a three-part Phase 1 clinical study of its lead candidate, TCP-25 gel, including evaluation in patients with EB. Xinnate is now preparing to launch the pivotal Phase 2/3 STEP study, expected to begin before the end of 2025.

For more information on the STEP study, please visit: clinicaltrials.gov (NCT06594393).

Xinnate is a SmiLe Venture Hub member.

www.xinnate.com

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