Microbion to Present Design of Ongoing Phase 2 Study Treating Diabetic Foot Ulcer Infections at the 2023 Military Health System Research Symposium
- Poster presentation describes Phase 2 study assessing safety and efficacy of topical pravibismane in subjects suffering from moderate infections associated with chronic diabetic foot ulcers
- Phase 2 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)
- Poster presentation to take place August 14th to 17th, 2023, at the Gaylord Palms Resort and Convention Center in Kissimmee, FL
BOZEMAN, MT. August 14, 2023 -- Microbion Corporation today announced that the company will be presenting a poster that highlights key clinical study design elements from an ongoing phase 2 study assessing safety and efficacy of topical pravibismane in subjects suffering from moderate infections associated with chronic diabetic foot ulcers at the 2023 Military Health System Research Symposium being held from August 14th to 17th, 2023, at the Gaylord Palms Resort and Convention Center in Kissimmee, FL. This Phase 2 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 drug in a new class of therapeutics that have a novel mechanism of action and broad-spectrum anti-infective and anti-biofilm activity, including activity against antibiotic-resistant organisms commonly associated with diabetic foot infection (DFI) such as Staphylococcus aureus, Pseudomonas aeruginosa and obligate anaerobic bacteria.
Title: Investigating safety, tolerability, and efficacy of topically applied pravibismane in subjects with moderate diabetic foot infection: Phase 2 randomized, open label, controlled, multi-center study (MHSRS-23-10337).
Presenter: Dr. Brett Baker, President and Chief Innovation Officer of Microbion Corp.
Time/Location: August 16, 2023, 10:00am – 12:00pm ET. Poster Session #3 (Antimicrobial Countermeasures for Wound Infections in Military Personnel), Florida Exhibit Hall A-D, #92.
Phase 2 study 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 randomized 2:1, respectively.
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 including: complete wound closure; reduction in the number and extent of amputations; reduction in wound size; and resolution of infection.
In previous Phase 1b/2a studies, topical and local administration of pravibismane was safe and well tolerated, while demonstrating signals of clinical efficacy in patients with moderate to severe diabetic foot infection and orthopedic device infections.
“We are excited to share our Phase 2 diabetic foot infection study design with the broader military community,” said Dr. Brett Baker, President and Chief Innovation Officer at Microbion Corporation. “Positive safety and efficacy results from this study could potentially provide proof of concept for use of topical pravibismane as a medical countermeasure in treating open injuries, particularly those contaminated wounds that are at risk of biofilm formation suffered by military personnel during combat in the field or recovery at the hospital.”
Microbion is a clinical-stage pharmaceutical company developing a new class of therapeutic compounds to improve the lives of patients with rare and serious diseases. Microbion's lead drug candidate, pravibismane, is the first product in this new class and has multiple novel modes of action, including potent broad spectrum anti-infective and antibiofilm activity, offering unique potential to address the unmet needs of chronic and severe health conditions. The Company is advancing inhaled pravibismane in Phase 1 clinical development for the treatment of chronic lung diseases, including non-tuberculous mycobacteria (NTM) and cystic fibrosis-related lung infections. Topical/local pravibismane is in Phase 2 development for the treatment of chronic wounds and orthopedic infections. Pravibismane has received backing from the Cystic Fibrosis Foundation, NIH, US DoD, and CARB-X with over $21 million in grants. The FDA has granted pravibismane Orphan Drug, Fast Track, and QIDP designations.
For more information visit: www.microbioncorp.com.
Safe Harbor Statement
Certain of the statements made in this press release are forward-looking, such as those, among others, relating to the success of clinical development of pravibismane or MBN-101 and preparation for potential commercialization. These statements are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated, including, but not limited to, risks and uncertainties related to: our ability to enroll patients in our clinical trials at the pace that we project; the size and growth of the potential markets for pravibismane or MBN-101 or any future product candidates and our ability to serve those markets; our ability to obtain and maintain regulatory approval of pravibismane or MBN-101 or any future product candidates; and our expectations regarding the potential safety, efficacy or clinical utility of pravibismane or MBN-101 or any future product candidates. Actual results or developments may differ materially from those projected or implied in these forward-looking statements. Microbion Corporation disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
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