2024-05-07 09:24Press release

Xinnate reports positive results from Phase 1 study with TCP-25, in patients with Epidermolysis Bullosa

Professor Artur Schmidtchen och Helene HartmanFounders Professor Artur Schmidtchen och CEO Helene Hartman

Lund, Sweden – Xinnate AB, today announced the headline read-out from the third and final part of the 1 a/b study with TCP-25, in patients with Epidermolysis Bullosa (EB), showing positive safety, tolerability and pharmacokinetic data as well as signs of wound healing efficacy.

The primary objective of this three-part Phase 1a/b study was to evaluate the safety of TCP-25 gel, Xinnate’s drug candidate, for the treatment of Epidermolysis Bullosa (EB). EB is a group of rare, often very severe disorders which causes fragile, blistering skin, resulting in recurring and chronic wounds. In the final third part of the study, patients with EB were included and treated with TCP-25 gel for 4 weeks.

The results now show a good safety and tolerability of TCP-25 gel, when administered topically in this patient population. As previously announced no SAE were reported in the study. The pharmacokinetic analysis shows, as expected, no detectable systemic uptake of TCP-25 in plasma. Additionally, wound healing trends are demonstrated in this cohort of EB patients.

“This data gives us additional confidence for our ongoing development of TCP-25 gel. We are currently preparing for the Phase 2 study by producing drug product and selecting participating sites”, said Xinnate´s CEO Helene Hartman.

More information about the completed Phase 1a/b study can be found at clinicaltrials.gov. ID: NCT05378997.

For more information
Helene Hartman, CEO
Phone: +46 (0)72-512 03 12

About Xinnate
Xinnate is a pharmaceutical development company that develops novel, pharmaceutical therapies based on a pioneering technology of immune modulating peptides, that targets dysfunctional healing by controlling presence of microbes and the complex interplay of inflammatory responses. Xinnate runs an ambitious development program to transform lives for patients with high unmet medical need in inflammatory skin conditions, wounds and surgical procedures. The company´s first drug candidate TCP-25 gel, is a novel pharmaceutical based on a synthetically manufactured peptide, TCP-25.

Language: English

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