Pipeline

Diabetic Foot Ulcer Infection

Diabetic foot infections (DFIs) are the leading cause of diabetes-related hospitalizations and one of the leading causes of lower limb amputation.1,2 While mild infections may be easily treated, moderate infections may be limb threatening, and severe infections may be life threatening.1 The estimated lifetime risk in a person with diabetes mellitus of developing a foot ulcer ranges from 15% to 25%. The incidence and complications related to DFIs has drastically increased due to the higher incidence of multidrug resistant (MDR) organisms, and the prevalence of MRSA involvement in DFIs in the US has increased from 11.6% to 21.9% between 2003 and 2007.4,5 It has been suggested that Gram-positive bacteria tend to predominate in acute DFIs, and Gram-negative and anaerobes tend to predominate in more persistent, chronic infections. 5,6

Recent studies have also demonstrated that in many chronic wounds such as DFIs, bacteria exist in biofilm communities, which are more resistant to currently available systemic antimicrobial therapy (i.e. antimicrobials taken intravenously or orally).7,8 In a combined analysis of chronic wound studies, biofilm was present in nearly 80% of the chronic wounds.9

Our Solution

Topically administered MBN-101, an investigational therapy, has the potential to provide important advantages for the treatment of DFIs, including the dual broad-spectrum antimicrobial and anti-biofilm effects of the drug and its ability to kill common antibiotic resistant species. Standard of care is frequently ineffective in treating these patients. We are conducting a study to show that MBN-101 used in conjunction with standard of care potentially improves bacteria and biofilm clearing and resolution. Ineffective management of DFIs has the potential to result in: lower limb amputations; high treatment costs; additional hospitalizations; and the need for long courses of systemic antibiotics.

MBN-101-202 Diabetic Foot Infection Study

A Phase 1b/2a clinical study of topically applied MBN-101with adjunct systemic antibiotic in patients with moderate to severe Diabetic Foot Infection (DFI) is currently ongoing. The main objectives of the study are to evaluate the safety and tolerability of topically administered MBN-101 and the effect of adjunctive MBN-101 on resolution of infection.

Additional information about the study can be found here:

Clinical Trial for DFI

Qualified Infectious Disease Product (QIDP) designation and Fast Track status was granted by the US FDA for adjunctive treatment of moderate and severe diabetic foot ulcer infections.

References
  1. Lipsky BA. Medical treatment of diabetic foot infections. Clin Infect Dis. 2004;39:S104-114.
  2. Jeffcoate WJ et al. Unresolved issues in the management of ulcers of the foot in diabetes. Diabet Med. 2008;25:1380-1389.
  3. Gemechu, FW et al. Diabetic foot infections. Am Fam Physician. 2013;88:177-184.
  4. Khoharo HK et al. Diabetic foot ulcers: Common isolated pathogens and in vitro antimicrobial activity. Prof Med J. 2009;16:53–60.
  5. Lipsky BA et al. Skin and soft tissue infections in hospitalised patients with diabetes: culture isolates and risk factors associated with mortality, length of stay and cost. Diabetologia. 2010;53:914-923.
  6. Lipsky BA et al. 2012 Infectious Diseases Society of America clinical practice guideline for the diagnosis and treatment of diabetic foot infections. Clin Infect Dis. 2012;54:e132-173.
  7. James GA et al. Biofilms in chronic wounds. Wound Repair Regen. 2008;16:37-44.
  8. Attinger A and Wolcott R. Clinically addressing biofilm in Chronic Wounds. Advances in Wound Care. 2012;1:127-132.
  9. Malone M et al. The prevalence of biofilms in chronic wounds: a systematic review and meta-analysis of published data. J Wound Care. 2017;26:20-25.