First Scientific Publication Reporting Clinical Trial Results for Xinnate’s Proprietary Drug Candidate TCP-25
Helene Hartman, CEO of XinnateLund, Sweden – Xinnate AB today announces the publication of its first-in-human, open-label, single-arm clinical study evaluating the safety, tolerability, and systemic exposure of topically applied TCP-25, the company’s novel immunomodulatory peptide, in patients with Epidermolysis Bullosa (EB).
In this Phase 1 study, topical administration of TCP-25 gel was safe and well tolerated in patients with dystrophic EB, with no detectable systemic uptake. Exploratory clinical assessments also showed a consistent reduction in open wound size in TCP-25–treated wounds, indicating potential for accelerated wound healing.
The full results are presented in the article “Results of a Non-Randomized, Open-Label Phase I Study Evaluating the Novel Immunomodulatory Peptide TCP-25 for Treatment of Dystrophic Epidermolysis Bullosa” by Karl Wallblom, Katja Holmgren, Sigrid Lundgren, Emma Belfrage, Torborg Hoppe, Matilda Hugerth, Anna-Karin Lindqvist, Enikö Sonkoly, and Artur Schmidtchen, published in Orphanet Journal of Rare Diseases: Link
About TCP-25
TCP-25 is a novel immunomodulatory thrombin-derived C-terminal peptide with demonstrated anti-inflammatory, antimicrobial, and wound-healing properties.
About TCP-25 gel
Xinnate’s lead drug candidate, TCP-25 gel, is a topical formulation developed for the treatment of Epidermolysis Bullosa
For more information
Helene Hartman, CEO Xinnate, 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 correct 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 member company in SmiLe Venture Hub.
About SmiLe Venture Hub – Pioneering Life Science and Foodtech Innovations
SmiLe is a leading venture hub that specializes in advancing life science and foodtech startups from concept to commercialization. We offer comprehensive support through every stage of entrepreneurship, including tailored incubation and acceleration programs, a variety of educational courses, and access to top-tier lab facilities. To date, our flagship incubator program has supported over 120 startups, facilitating their collective acquisition of more than EUR 1.16 billion in venture capital and contributing to 21 successful IPOs. Recognized as one of Europe’s leading startup hubs in 2024 by the Financial Times and Statista, SmiLe continues to be a catalyst for innovation in the life sciences sector. As a non-profit entity based in Lund, Sweden, SmiLe is supported by Region Skåne, Lund Municipality, Lund University, and Medicon Village. We are also backed by our partners Agilent, Sparbanken Skåne, Høiberg, Setterwalls, Zacco, Key2Compliance, Phase Holographic Imaging, ChemoMetec, Samplix, Qiagen, Bio-Rad, Zeiss, SmartStone Nordics, Säkra, Servier and AbbVie Scandinavia. For more information: www.smileventurehub.com
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