Innocoll, Inc. announced Nov. 9th it had filed an Investigational New Drug (IND) application with the U.S. Food and Drug Administration for its CollaRx Gentamicin as a topical antibiotic treatment for diabetic foot ulcers that are clinically infected or at risk of infection.

CollaRx Gentamicin is a biodegradable and fully resorbable Gentamicin-Collagen Sponge formulated and manufactured using Innocoll's proprietary CollaRx technology.

The product releases gentamicin, a broad-spectrum, concentration-dependent aminoglycoside antibiotic, 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, as a surgical implant, is already approved and marketed in Europe as an adjunct to systemic therapy for the treatment and prevention of post-surgical site acquired infection.

ublished clinical case studies and anecdotal reports from clinicians using the marketed product strongly suggest its effectiveness in the treatment and cure of infected chronic wounds, including diabetic foot ulcers.

Practically all diabetic foot ulcers are colonized with pathogenic bacteria, and a high proportion become clinically infected requiring treatment with antibiotics, Innocoll said.

Orally administered and injected antibiotics are often associated with systemic side effects, and widespread use leads to development of bacterial resistance. Furthermore, diabetic ulcers are often associated with vascular disease and restricted peripheral blood flow (ischemia), which may render systemically acting antibiotics less effective.

Currently, there are no topically applied antibiotics marketed in the US that are specifically indicated for the treatment of infected diabetic foot ulcers.

Innocoll plans to study the treatment of diabetic foot infections of varying severities, as defined according to the clinical classification in the IDSA Guidelines, in a series of phase 2 trials.

The lead indication is the treatment of mild infection where CollaRx Gentamicin will be compared to an orally administered antibiotic. In subsequent trials, Innocoll plans to investigate the product as an adjunct to systemic therapy for treating infections of higher severity and also as a method to prevent ulcers from becoming clinically infected.