BALI

Biofilm Alliance

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 Obiettivo del progetto (Objective)

'Infections by biofilm-forming microorganisms on indwelling medical devices such as catheters, prosthetic joints and internal fracture fixation devices pose a serious health threat. Overall, approximately 3% of all patients receiving such devices develop biofilm infections, with costs adding up to billions of Euro’s. Current strategies to combat biofilms are based on conventional antibiotics. They often fail because 1) biofilms are difficult to penetrate, 2) micro-organisms in biofilms are resistant to most conventional antibiotics, 3) antibiotics cause release of pro-inflammatory microbial compounds, and 4) the locally available concentrations are too low. The aim of BALI is to disrupt biofilm formation by a unique combination of Synthetic Antimicrobial Antibiofilm Peptides (SAAPs) with biofilm dispersing, microbicidal, and immune-orchestrating activity, incorporated in novel controlled release drug delivery formulations (PolyPid), for both prevention and treatment of biofilm infections. The recently developed SAAP OP-145, already tested in humans, will be the first candidate. PolyPid, a unique polymer-lipid-based drug delivery platform will be tailored for coatings allowing prolonged and pre-determined release rates of SAAPs, to ensure the required local concentrations over a desired period. The coatings will be optimized in vitro and subsequently in mice and rabbit studies to prevent and treat biofilm infection. Finally a phase 1 study in patients with bone fracture fixation devices will be performed. The novel SAAP-delivering PolyPid formulations can control biofilms and allows for treatment and management of infections, reducing infection rates of implanted medical devices. Patients relying on safe and effective medical devices thus will benefit strongly by reduction of infection frequencies. Besides improved health of EU citizens, the associated cost savings for hospitals and the economic benefits for the SMEs contribute to realization of EC policies'

Introduzione (Teaser)

Biofilm-forming microorganisms are a growing problem particularly in healthcare. A European study is looking to address this issue through coating of medical implants with specialised anti-bacterial materials.

Descrizione progetto (Article)

Biomaterial-associated infection (BAI) in implant devices is caused by biofilm formation mainly of Staphylococcus aureus and coagulase-negative staphylococci. BAI is very difficult to treat with antibiotics and alternative approaches are urgently needed to combat such infections.

The scope of the EU-funded BALI (Biofilm alliance) project is to provide a solution to BAI by combining highly innovative technologies. The consortium aims to generate synthetic antimicrobial and anti-biofilm peptides (SAAP) along with a release system for application of coating to the surface of biomaterials.

Researchers used the synthetic OP-145 peptide, because of its potent anti-inflammatory, antimicrobial and anti-biofilm activity, as the basis to derive other candidate peptides. The human blood platelet antimicrobial protein Thrombocidin-1 has also served as the starting template for SAAP synthesis. Ten peptides have been tested so far to assess their capacity to kill a wide spectrum of gram-positive and -negative bacteria.

Insight into the mode of action of these SAAPs indicate that on top of their ability to prevent biofilm formation, they exhibit strong anti-inflammatory activity. In vitro experiments also showed that OP-145 affects the integrity of both bacterial and mammalian membranes.

To achieve controlled release of SAAPs, scientists employed the PolyPid polymer-lipid-based drug delivery platform. Following extensive optimisation to make it suitable for coatings, it has successfully been used to cover implants in various animal models. Upon challenge with S.aureus, SAAPs prevented infection in these animals clearly demonstrating its clinical potential.

The consortium is confident that apart from preventing biofilm formation, this approach will also reduce the development of antimicrobial resistance. Considering the increasing number of hip fractures in Europe, the BALI method is anticipated to reduce infection risk as well as operative and hospitalisation costs.