PRESS RELEASE March 18, 2024:
Xinnate AB, a pharmaceutical development company that develops novel, pharmaceutical therapies that targets dysfunctional healing in inflammatory skin conditions, today announced the completion of its clinical Phase 1 a/b study with TCP-25.
The primary objective of this three-part Phase 1a/b study is to evaluate the safety of TCP-25, 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 Part I of the study healthy volunteers with acute epidermal wounds formed by the suction blister technique were included and in Part II patients with non-healing leg ulcers were enrolled. In the final third part, patients with EB were included and treated with TCP-25 for 4 weeks. In total, the study included 35 participants, and they have now all completed the study.
“We have used a step-wise approach in our phase 1 program, continuously implementing our learnings from the previous parts. I am especially delighted about the generation of data with TCP-25 in our target indication EB”, said Xinnate´s CEO Helene Hartman.
“I would like to extend our gratitude to all patients and their families who participated in the study, as well as the clinicians and CRO staff for their excellent work”, continued Helene Hartman.
No serious adverse events (SAEs) have been reported in the study. The next step is to process and evaluate data, including biomarkers and clinical assessments. Thereafter, Xinnate plans to start a clinical Phase 2 study in patients with EB.
More information about the completed Phase 1a/b study can be found at clinicaltrials.gov. ID: NCT05378997. The method for part I of the study is published in in BMJ Open by Dr. Sigrid Lundgren et al1
1Lundgren S, Wallblom K, Fisher J, et al. Study protocol for a phase 1, randomised, double-blind, placebo-controlled study to investigate the safety, tolerability and pharmacokinetics of ascending topical doses of TCP-25 applied to epidermal suction blister wounds in healthy male and female volunteers. BMJ Open. 2023 Feb 22;13(2):e064866. doi: 10.1136/bmjopen-2022-064866. https://pubmed.ncbi.nlm.nih.gov/36813496/