EB is a severe, debilitating, and currently underserved rare disease. This regulatory milestone enables the initiation of The STEP study, a 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 US market,” says Helene Hartman, CEO of Xinnate.

The STEP study

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, describes the company. 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, it states.

Source: SmiLe Venture Hub