Periodic Reporting for period 1 - NABIHEAL (ANTIMICROBIAL NANOSTRUCTURED BIOMATERIALS FOR COMPLEX WOUND HEALING)
Reporting period: 2023-01-01 to 2024-06-30
Complex wounds are a global health problem with significant impact on the health care economy. In developed countries alone, they impact the quality of life of more than 2% of total population. Complex wounds, including chronic wounds or major burns, are highly susceptible to microbial infection and biofilm formation, and difficult to treat. Moreover, silver is a widely used metal in antimicrobial products to treat wound infections. However, silver-based products are expensive, and show several drawbacks due to costs, as well as environmental and safety concerns. The NABIHEAL project will develop multifunctional biomaterials, from proof-of-concept (TRL 3) to the preclinical regulatory stage (TRL 5), to improve wound management. The resulting biomaterials will enable affordable treatment of wound infections or prevention of complications during all phases of the wound healing process. In the short and medium term, NABIHEAL will develop at least two innovative multifunctional wound-healing biomaterials, using affordable EU-based manufacturing technologies. In the long term, NABIHEAL could become a game-changing alternative to silver in wound-healing dressings. A consortium comprising 5 SMEs and 9 academic institutions, with expertise in wound healing product development, evaluation and commercialization, nanotechnology, safety, and regulatory affairs, will join forces to address these ambitious objectives.
At M18, NABIHEAL project is successfully being implemented under the coordination of the public research consortium CIBER on biomedicine and health sciences and its affiliated entity CSIC research institution.
All partners are fully engaged through the activities of the project, and no major deviations have been detected. Currently, up to 5 different new biomaterials are being developed for the treatment of complex wounds, and it is expected that at least two of these new materials will enter in further in vivo testing on 2025, as proposed in the DoA.
Overall, 9 work packages (WPs) are working together to advance towards the objectives of the project. The development of the novel multifunctional biomaterials is carried out in the frame of WP1, Design and optimization of multifunctional biomaterials (WP lead: CIBER), and WP2, Physicochemical characterization tools and definition of critical quality attributes (CQA) (WP lead: University of Maribor). The efficacy of the new biomaterials is being evaluated using established in vitro and ex vivo models for antimicrobial and wound healing capacity in the frame of WP3 (WP lead: Charité Hospital).
The most promising biomaterial candidates in terms of physicochemical characteristics, antimicrobial, and wound healing activity will be scaled up and manufactured considering GMP in WP4 devoted to scaling up and CMC (WP lead: MyBiotech GmbH). These systems will have the required quantity and quality to carry out the in vivo evaluation of efficacy and toxicology, in animal models (WP3 and WP5, Biocompatibility and safety evaluation (WP5 lead: Institute of medical research IMROH).
Along all the period, regulatory guidance has been provided by WP6, Regulatory aspects and ethics (WP6 lead: Asphalion SA consultancy), to advise on the most advisable strategic approaches to be taken with regard on the different product development stages up to the first administration in humans. Additionally, during the initial phase of the project, significant work in the frame of WP7, Business Development and Exploitation (WP leads: biotech companies Nanomol Technologies SL & Histocell SL), has begun to ensure that the project results are effectively translated into benefits for patients with complex wounds.
All these WPs are closely collaborating with WP8, Dissemination, Communication and Stakeholder involvement (WP lead: BioNanoNet), whose activities expect to be more intensive in the latter stages of the project. Importantly, under the frame of WP9, Project and Data Management (WP lead: CIBER) a data management system has been implemented to monitor, secure, organize and maintain all data generated within NABIHEAL project.
All partners are fully engaged through the activities of the project, and no major deviations have been detected. Currently, up to 5 different new biomaterials are being developed for the treatment of complex wounds, and it is expected that at least two of these new materials will enter in further in vivo testing on 2025, as proposed in the DoA.
Overall, 9 work packages (WPs) are working together to advance towards the objectives of the project. The development of the novel multifunctional biomaterials is carried out in the frame of WP1, Design and optimization of multifunctional biomaterials (WP lead: CIBER), and WP2, Physicochemical characterization tools and definition of critical quality attributes (CQA) (WP lead: University of Maribor). The efficacy of the new biomaterials is being evaluated using established in vitro and ex vivo models for antimicrobial and wound healing capacity in the frame of WP3 (WP lead: Charité Hospital).
The most promising biomaterial candidates in terms of physicochemical characteristics, antimicrobial, and wound healing activity will be scaled up and manufactured considering GMP in WP4 devoted to scaling up and CMC (WP lead: MyBiotech GmbH). These systems will have the required quantity and quality to carry out the in vivo evaluation of efficacy and toxicology, in animal models (WP3 and WP5, Biocompatibility and safety evaluation (WP5 lead: Institute of medical research IMROH).
Along all the period, regulatory guidance has been provided by WP6, Regulatory aspects and ethics (WP6 lead: Asphalion SA consultancy), to advise on the most advisable strategic approaches to be taken with regard on the different product development stages up to the first administration in humans. Additionally, during the initial phase of the project, significant work in the frame of WP7, Business Development and Exploitation (WP leads: biotech companies Nanomol Technologies SL & Histocell SL), has begun to ensure that the project results are effectively translated into benefits for patients with complex wounds.
All these WPs are closely collaborating with WP8, Dissemination, Communication and Stakeholder involvement (WP lead: BioNanoNet), whose activities expect to be more intensive in the latter stages of the project. Importantly, under the frame of WP9, Project and Data Management (WP lead: CIBER) a data management system has been implemented to monitor, secure, organize and maintain all data generated within NABIHEAL project.
Results beyond the state of the art are anticipated once this project reaches its full potential, since it is currently in its early stages. As development progresses, we expect groundbreaking outcomes that will contribute to reach the objectives of the project.