Periodic Reporting for period 2 - NABIHEAL (ANTIMICROBIAL NANOSTRUCTURED BIOMATERIALS FOR COMPLEX WOUND HEALING)
Berichtszeitraum: 2024-07-01 bis 2025-12-31
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 chronic wound management, which represent around 70-90% of complex wounds. 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 potential alternative to silver in wound-healing dressings. A consortium comprising 5 SMEs and 10 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 M36, NABIHEAL project is successfully being implemented under the coordination of the public research consortium CIBER on biomedicine and health sciences (ICMAB-CSIC) and Nanomol Technologies SL.
All partners are fully engaged through the activities of the project, and no major deviations have been detected. At this stage of the project, important advances have been made in relation to the design and development of new biomaterials with antimicrobial and wound healing functionalities. Several products were developed as potential candidates for in vivo testing. From 14 initial candidates, three products were selected as the most promising for further development. Currently, these three new biomaterials have reached the in vivo testing phase for the treatment of chronic wounds, which will be completed during 2026 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, ex vivo and in 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 are currently being scaled up and manufactured considering GMP in WP4 devoted to scaling up and CMC (WP lead: MyBiotech GmbH). The in vivo tested systems were produced with 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. Two roadmaps were generated for Nabiheal new products. Additionally, significant work in the frame of WP7, Business Development and Exploitation (WP leads: biotech companies Nanomol Technologies SL & Histocell SL), has been done to ensure that the project results are effectively translated into benefits for patients with complex wounds. Nabiheal results protection has been started and a first exploitation plan has been stablished.
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 last year of the project, once IP protection has been properly addressed. 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. At this stage of the project, important advances have been made in relation to the design and development of new biomaterials with antimicrobial and wound healing functionalities. Several products were developed as potential candidates for in vivo testing. From 14 initial candidates, three products were selected as the most promising for further development. Currently, these three new biomaterials have reached the in vivo testing phase for the treatment of chronic wounds, which will be completed during 2026 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, ex vivo and in 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 are currently being scaled up and manufactured considering GMP in WP4 devoted to scaling up and CMC (WP lead: MyBiotech GmbH). The in vivo tested systems were produced with 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. Two roadmaps were generated for Nabiheal new products. Additionally, significant work in the frame of WP7, Business Development and Exploitation (WP leads: biotech companies Nanomol Technologies SL & Histocell SL), has been done to ensure that the project results are effectively translated into benefits for patients with complex wounds. Nabiheal results protection has been started and a first exploitation plan has been stablished.
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 last year of the project, once IP protection has been properly addressed. 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.
RP2 has generated significant results that contribute to advancing beyond the current state of the art by developing new biomaterials aligned with the project objectives. While final outcomes will be reached in later stage of the project, the achievements in RP2 are a strong basis for facing the last year of the Project.
RP2 has achieved significant progress in identifying three promising different biomaterial candidates to promote wound healing in the presence of bacteria, which are currently under in vivo evaluation (efficacy and toxicity). These advances go beyond the current state of the art by combining systematic candidate selection with comprehensive physicochemical characterisation and the definition of critical quality attributes in line with preclinical regulatory requirements and scale-up strategies. IP protection of the new results is currently on-going. A first exploitation analysis has been done to transform the project results in new marketed products for chronic wounds treatment.
RP2 has achieved significant progress in identifying three promising different biomaterial candidates to promote wound healing in the presence of bacteria, which are currently under in vivo evaluation (efficacy and toxicity). These advances go beyond the current state of the art by combining systematic candidate selection with comprehensive physicochemical characterisation and the definition of critical quality attributes in line with preclinical regulatory requirements and scale-up strategies. IP protection of the new results is currently on-going. A first exploitation analysis has been done to transform the project results in new marketed products for chronic wounds treatment.