Helene Hartman

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

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.

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.

For more information
Helene Hartman, CEO
Helene.hartmann@xinnate.com
Phone: +46 (0)72-512 03 12

by Helene Hartman

Xinnate completes Phase 1a/b study with TCP-25

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/

by Helene Hartman

Xinnate secures 100 million SEK in financing and applies for a patent for the treatment of Epidermolysis Bullosa

Lund, Sweden, February 7, 2024

PRESS RELEASE

Xinnate conducted a new share issue of 100 million SEK from private investors last year. The funding enables an upcoming phase-2 study for the company's first drug—a gel for topical treatment of dysfunctional healing in wounds or inflammatory skin conditions. A phase-1 study in three parts is currently underway, including one part with patients suffering from the rare and severe disease Epidermolysis Bullosa. Planning for a multi-site phase-2 study with EB patients is ongoing.

– It is incredibly powerful that we can support the patent application with existing results from our clinical study. We aim to develop a drug that reduces harmful inflammation, improves the healing process, and reduces the risk of serious complications, says Helene Hartman, CEO of Xinnate.

Read full press release here

by Helene Hartman

Xinnate appoints Anna-Karin Lindqvist as new COO

We are delighted to welcome Anna-Karin Lindqvist to our team as our new COO.

With extensive experience in the pharmaceuticals industry, Anna-Karin has proven expertise in bringing pharmaceutical products from discovery through to market authorization approval and launch. Her arrival marks a significant milestone for our team as we prepare for the next phase of development. Please join us in welcoming Anna-Karin to our team!

by Helene Hartman

Approved clinical trial application for BioC gel on complex wounds

The CTA (Clinical Trial Application) has been approved by the Swedish Medical Products Agency (Läkemedelsverket) and the Ethics committee. The study will include patients with large complex wounds and the aim is to show safety and tolerability.

by Helene Hartman

Excellent results from phase I study shows that the BioC gel is safe and well tolerated.

The first part of the phase I study has now been unblinded. The result shows that BioC gel is both safe and well tolerated. There were no adverse events reported and no systemic effect detected.

by Helene Hartman

Funding secured for the next step of BioC clinical plan

The interest was very high and a new issue of 14M SEK was oversubscribed. The money will be used for the clinical phase Ib study on patient with complex wounds and for preparation of the clinical trial phase II.

by Helene Hartman

Xinnate is awarded a prestigious grant from the US Department of Defense

Xinnate is awarded prestigious grant from the US Department of Defense (DoD) of 1,77M USD over three years. The grant was issued by US Army Medical Research Acquisition Activity (USAMRAA) and will be used for development of a BioC based formulation in the project entitled ”Prevention and Treatment of Infection and Inflammation in Pressure Ulcers”. The project will run in parallel with the clinical work on acute wounds.
Martin Malmsten, Professor in Biopharmaceuticals, Biophysics and Drug Delivery at the University of Copenhagen and the Director of LEO Foundation Center for Cutaneous Drug Delivery, has taken on the role as Sr advisor and will support the project.

by Helene Hartman

Approved clinical trial application for First in Human study on BioC gel

The Swedish Medical Products Agency (Läkemedelsverket), and the Ethics committee have approved the Clinical Trial Application of the Phase I, a First in Human study on BioC gel. They study will be run at Lund University Hospital and will include healthy volunteers and treatment of epidermal skin wounds. The aim of the study is to show safety and tolerability.

by Helene Hartman