Periodic Reporting for period 2 - WOUNDCOM (The first bioactive wound dressing - exploiting the unique wound healing and antimicrobial properties of human collagen VI)
Berichtszeitraum: 2021-05-01 bis 2025-12-31
Colzyx addresses the problem of the wound management of non-healing (chronic) wounds.
Human collagen VI has unique wound healing and antimicrobial properties in the same molecule. Colzyx has identified, isolated and further developed key molecules from Human collagen VI and combined and optimised these to create a first-in-category bioactive product for wound management.
The product, WOUNDCOM, not only successfully manipulates the wound environment to facilitate healing but also forms an antibacterial barrier. WOUNDCOM caters to the large portion of previously unhealable wounds, accelerating the wound healing process and, at the same time, combating bacterial infections, including multi-drug resistant bacterial infections.
The value for society is healing of chronic wounds that will improve patient´s quality of life as well as providing health economic benefits.
The overall objectives of the project include:
- Developing and manufacture the clinical trial material according to quality and regulatory requirements for the clinical studies
- Determining WOUNDCOM wound healing performance in the treatment of chronic venous leg ulcers through the clinical trial
- Bringing the product to commercial readiness by completing the clinical validation study and obtaining CE-marking of the product.
- Building the trust in the product among potential partners and investors by validating efficacy & safety.
Human collagen VI has unique wound healing and antimicrobial properties in the same molecule. Colzyx has identified, isolated and further developed key molecules from Human collagen VI and combined and optimised these to create a first-in-category bioactive product for wound management.
The product, WOUNDCOM, not only successfully manipulates the wound environment to facilitate healing but also forms an antibacterial barrier. WOUNDCOM caters to the large portion of previously unhealable wounds, accelerating the wound healing process and, at the same time, combating bacterial infections, including multi-drug resistant bacterial infections.
The value for society is healing of chronic wounds that will improve patient´s quality of life as well as providing health economic benefits.
The overall objectives of the project include:
- Developing and manufacture the clinical trial material according to quality and regulatory requirements for the clinical studies
- Determining WOUNDCOM wound healing performance in the treatment of chronic venous leg ulcers through the clinical trial
- Bringing the product to commercial readiness by completing the clinical validation study and obtaining CE-marking of the product.
- Building the trust in the product among potential partners and investors by validating efficacy & safety.
In terms of the project management, the work proceeded as planned, with regular meetings with partners and clinicians. In relation to WOUNDCOM development, WOUNDCOM was developed according to the regulatory requirements and according to plan. The project was prematurely ended due to unforeseen requirements from the German authority BfArM. Colzyx has engaged in presentation of WOUNDCOM on both business and scientific events during the project.
The available wound care options can manipulate one or multiple aspects of the wound environment, but cannot form an antibacterial barrier and facilitate healing to a satisfactory level at the same time. Comparing to today’s wound dressings, WOUNDCOM will cater to the largest needs in wound management: fast wound healing process and combat of bacterial infection.