Innocoll is developing CollaRx GENTAMICIN TOPICAL for the treatment and prevention of diabetic foot infections of varying severities, as defined according to the clinical classification in the IDSA Guidelines. An IND has been filed in the US and Innocoll has received FDA approval to commence Phase II clinical trials.

CollaRx GENTAMICIN TOPICAL is a biodegradable and fully resorbable Gentamicin-Collagen Sponge formulated and manufactured using Innocoll's proprietary collagen-based drug delivery technology, CollaRx. Upon application to a wound, the product releases gentamicin, a broad-spectrum, aminoglycoside antibiotic (having a concentration-dependent mechanism of action), for local action. This achieves a high concentration of drug at the target tissue, while maintaining low systemic levels well below the toxicity threshold.

CollaRx GENTAMICIN TOPICAL represents the clinical development of Innocoll's Gentamicin-Collagen Sponge as a therapy for the treatment and prevention of infected chronic wounds. The product is already approved and marketed in Europe and other non-US territories as a surgical implant for the treatment of localized, deep tissue infections and the prevention of surgical site infections in both hard and soft tissues.

The development of the topical indication is based upon a series of published clinical case studies and anecdotal reports from clinicians where the marketed implant product was applied topically to chronic wounds of various etiologies. This data supports its effectiveness for such clinical applications, particularly in the treatment of infected diabetic foot ulcers.

Out-license and co-development in the US.