Microbion Corporation today announced that a Phase 2, randomized, controlled study has been initiated to assess the safety and efficacy of topical pravibismane for the treatment of subjects with moderate infections of chronic diabetic foot ulcers (DFU). DFU infections are a serious complication of diabetes associated with significant morbidity and mortality. DFU infections are the most frequent diabetic complication requiring hospitalization and may lead to lower extremity amputation if the infection fails to resolve. In 2018, approximately 8.25 million hospital discharges associated with diabetes were reported, including 154,000 for lower-extremity amputation.1 Estimates of 5-year mortality for DFU, minor and major amputations range from 30.5% to 56.6%.2  With the increasing global prevalence of diabetes, novel treatments for DFU infection represent an increasing global unmet need.

In this current Phase 2 exploratory study, Microbion plans to enroll 54 subjects with chronic moderate DFU infections, comparing 12 weeks of pravibismane treatment plus standard of care versus standard of care treatment alone. The study's main objective is to assess the safety and tolerability of topical pravibismane, while the secondary objective is to explore key signals of efficacy demonstrated in an earlier study. These efficacy endpoints include complete wound closure, reduction in the number and extent of amputations, reduction in wound size, and resolution of infection. This study is being conducted at select wound care sites in Texas and California, and potentially other U.S. sites in the future. More information about the study can be found on Clinicaltrials.gov (identifier number: NCT05174806).

In a previous Phase 1b randomized, double-blind, placebo-controlled trial treating patients with chronic moderate to severe DFU infection, three weeks of topical pravibismane treatment plus standard of care demonstrated a numeric 85% wound size reduction compared to 30% for placebo plus standard of care. Pravibismane also demonstrated a numeric 6-fold reduction in ulcer-related amputations (2.6% in the pravibismane group vs. 15.4% in the control group). Pravibismane was safe and well-tolerated at all doses.

This current study is funded, in part, by a $2.1 million award from the Naval Medical Research Center, Naval Advanced Medical Development (NMRC-NAMD) through CUBRC, Inc. and the Medical Technology Enterprise Consortium (MTEC).

Pravibismane is the first in a new class of anti-infective drugs demonstrating broad-spectrum potency against a wide range of multidrug-resistant bacteria, and biofilms ubiquitous in DFU infections and widely recognized as one of the leading causes of treatment failure. Topical pravibismane has been safe and well-tolerated in five clinical studies involving over 325 human subjects.

"We are extremely excited to have initiated this Phase 2 study and we're very pleased that subject enrollment has exceeded our projections, demonstrating the unmet medical need of patients with DFU infections," said Karim Lalji, Chief Executive Officer of Microbion Pharma Corp. "In addition to expanding our safety and tolerability data with topical pravibismane, this study was designed to further explore efficacy signals identified in our Phase 1b study, including pravibismane's impact on closing wounds and lowering risk of amputation. With the successful initiation of our latest study, we move closer to fulfilling Microbion's commitment to providing patients and stakeholders with new solutions to treat this debilitating complication of diabetes."

"We are delighted to be working with Microbion in this randomized clinical study to assess the effects of topical pravibismane in chronic diabetic foot ulcer infections," said Dr. Anna Sanchez, DPM, President of Bio-X-Cell Research, LLC, and a participating clinical investigator in the study. "One of the biggest unmet needs are advances to treat infection and accelerate healing in people with diabetes. Our hope is that this innovative approach will advance our ability to treat high-risk patients and prevent amputations."

"We are excited to evaluate topical pravibismane's efficacy in closing wounds and reducing the need for amputations in our patients suffering from chronic diabetic foot ulcer infection," said Dr. Shawn Cazzell, DPM, FAPWCA, FAPWH, Chief Medical Officer, Division of Chronic Wound and Podiatric Research at Limb Preservation Platform, Inc., and a participating clinical investigator in the study. "Given the growth of diabetes in our aging population and rise in DFU infections, novel agents, such as topical pravibismane, are needed to bolster the armamentarium for simple to use treatment options that manage infected, chronic ulcers and their associated biofilms to advance healing."

Approximately 28.5 million adults in the US are diagnosed with diabetes, of which 15 – 25% are at risk of developing foot ulcers.1,3 More than half of diabetic foot ulcers become infected.4 DFU infections remain the most frequent diabetic complication requiring hospitalization and are the most common precipitating event leading to lower extremity amputation.5 Furthermore, recent studies suggest that many DFU infections are caused by bacteria in a biofilm mode.5 The direct cost of diabetes in the U.S. in 2017 was $237 billion, of which one-third of these direct costs were attributable to care for diabetic foot disease.2

References:

1. Centers for Disease Control and Prevention. National Diabetes Statistics Report website. https://www.cdc.gov/diabetes/data/statistics-report/index.html. Accessed March 8, 2023.
2. Armstrong, DG et al. Five year mortality and direct costs of care for people with diabetic foot complications are comparable to cancer. J Foot Ankle Res. 2020;13:16. doi: 10.1186/s13047-020-00383-2
3. Lavery LA, Davis KE, Berriman SJ, et al. WHS guidelines update: Diabetic foot ulcer treatment guidelines. Wound Repair Regen. 2016;24(1):112–26. doi: 10.1111/wrr.12391
4. Armstrong, DG, Boulton, AJM, and Bus, SA. Diabetic foot ulcers and their recurrence. N Engl J Med.  2017;376:2367-75. doi: 10.1056/NEJMra1615439
5. Lipsky et al. Guidelines on the diagnosis and treatment of foot infection in persons with diabetes (IWGDF 2019 update). Diab Metab Res Rev. 2020. e3280. doi: 10.1002/dmrr.3280

 

Source:prnewswire.com

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