Galephar opens new perspectives in the treatment of chronic respiratory infections

Biopharmacy Home_Spotlight — 13 March 2013

Galephar will soon launch phase 1 clinical trials to confirm the effectiveness of new inhaled synergetic combinations in the treatment of cystic fibrosis.

Here lies yet another example of how Biowin, through its R & D projects, is setting the stage for the success of SMEs in Belgium. Galephar (Marche-en-Famenne, Belgium), following its involvement and contribution to the BioFiNa* project, and in collaboration with the project’s consortium, has successfully developed a highly original inhaled formulation that acts as an agent to break down the biofilm** responsible for severe respiratory conditions.

The 4-year R & D project has actually led Galephar to further the development of an innovative inhaled synergetic combination to treat chronic respiratory conditions caused by a bacteria producing biofilm; in this case, cystic fibrosis. The mechanisms that trigger the onset of bacterial resistance in respiratory pathologies such as cystic fibrosis, chronic obstructive pulmonary diseases and various types of pneumonia pathologies very often rely on the presence of such a biofilm. Currently there are no drugs that specifically target these biofilms.

During the Phase 1 clinical trials, Galephar will continue to carry out the necessary toxicology tests to establish the innocuousness of the inhalation formulation as well as carry out the first pharmacokinetic and clinical tests to confirm the effectiveness of this combination in the treatment of cystic fibrosis. Following its strategic involvement in the BioFiNa project, Galephar has now reached the end of the research stage and will continue to develop the innovative formulation until it is put on the market. Phase 1 clinical trials are expected to get under way in 2013 and will target European and North American markets first. The original formulation, which is protected by a strong patent portfolio, will first be used to treat Pseudomonas aeruginosa infections in patients with cystic fibrosis and ultimately will be used to treat respiratory infections that are resistant to conventional treatments.

Not only has the network developed by BioWin facilitated the collaboration between researchers in Wallonia and Brussels for Galephar but it has opened new research perspectives for the company as well. To date, Galephar has also submitted 6 patents applications and produced 11 scientific publications: GALEPHAR has patents on DPI composition, DPI device and a patent application for compositions active against the biofilms; ULB-LPB also holds patent applications for specific spray-dried compositions; and ULg (Human Histology Laboratory – HISTOHUM – Partner7) has filed patent applications on methods to extract microorganisms from biofilms.

Deservedly so its involvement with the BioFiNa project and further development of this particular inhaled formulation along with other potential inhaled synergetic combinations will hopefully lead to new opportunities for Galephar well into the future.

*The BioFiNa project began in 2008 and is led by a consortium comprising three SMEs Galephar (project coordinator), Microbelcaps and the Advanced Technology Corporation; and five university research centers. The project aims to develop and assess the activity of new pharmaceutical combinations made up of an antibacterial agent and an agent capable of dismantling the resistant biofilm administered by inhalation, both in vitro and in vivo.

**Biofilms are constituted of polysaccharides and/or alginate surfaces, resistant to traditional antibacterial agents, which cover bacterial microcolonies and which are consequently responsible for the persistence of the germ within the pulmonary parenchyma as well as the chronic underlying inflammation.

Sources: