Xinnate announces that recruitment has started and the first patient has been included in the STEP study with TCP-25
Helene Hartman, CEO of XinnateLUND, SWEDEN – Xinnate AB, a Swedish clinical-stage drug development company developing novel therapies based on its groundbreaking peptide technology, today announces that the first patient first visit (FPFV) has been completed in the company’s clinical Phase 2/3 study with TCP-25 for the treatment of Epidermolysis Bullosa (EB).
The STEP study is a global, randomized, placebo-controlled clinical trial evaluating the safety and efficacy of TCP-25 gel in patients with EB, a rare and severe genetic disease characterized by fragile skin, chronic wounds, severe pain, and an increased risk of infection. The study has been approved in the EU, and clinical sites in several European countries have been initiated. Clinical sites in the United States are also in the start-up phase.
“Including the first patient in the STEP study is an important milestone for Xinnate and for patients with EB, who currently lack satisfactory treatment options. We are very proud of the extensive scientific and clinical work that has made this possible, and we look forward to continuing the development of TCP-25 together with our clinical partners and patients,” says Helene Hartman, CEO of Xinnate.
The STEP study will include 32 patients with different EB subtypes, and the results have the potential to be registration-enabling.
For more information, please contact:
Helene Hartman, CEO helene.hartman@xinnate.com
About Xinnate AB
Xinnate is a Swedish clinical-stage drug development company developing novel therapies based on its unique, groundbreaking peptide technology. These therapies address dysfunctional healing by modulating the interaction between microbes and inflammatory processes. With an ambitious development program, Xinnate is dedicated to improving the lives of, primarily, patients with Epidermolysis Bullosa. Xinnate is a member of the SmiLe Venture Hub at Medicon Village in Lund.
www.xinnate.com
About TCP-25
TCP-25 is a novel immunomodulatory peptide with demonstrated anti-inflammatory, antimicrobial, and wound-healing properties. Xinnate’s lead drug candidate, TCP-25 gel, is a topical formulation developed for the treatment of Epidermolysis Bullosa (EB).
About the STEP study
The STEP study, protocol number TCP25-002, is a double-blinded, randomized, placebo-controlled study designed to evaluate the efficacy, safety, and tolerability of topically applied TCP-25 gel in patients with confirmed dystrophic EB (DEB) or junctional EB (JEB). The study uses intra-individual randomization, meaning that a pair of matched index wounds are randomized to local treatment with either TCP-25 gel or placebo. Approximately 32 patients from 4 years of age will be included in the study. The study is conducted in France, Greece, Italy, Spain, Sweden, and the United States.
For more information about the study, please see www.clinicaltrials.gov, ID: NCT06594393.
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 1.22 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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