Microbion Corporation Announces Results from Randomized, Double Blind, Placebo-Controlled Phase 1b Trial of Pravibismane (MBN-101) for Treatment of Moderate to Severe Chronic Infected Diabetic Foot Ulcers
- Treatment with pravibismane (MBN-101) was safe and well-tolerated
- Wound sizes were reduced three-fold and ulcer-related amputation reduced six-fold in treated group plus standard of care vs. placebo plus standard of care
- Findings presented at 2019 Symposium on Advanced Wound Care Fall Meeting
BOZEMAN, MT, and VANCOUVER, BC. October 28, 2019 – Microbion Corporation of Bozeman, MT, and Microbion Pharma Corp. of Vancouver, BC (“Microbion”) today announced results from a Phase 1b trial of its novel microbial bioenergetic inhibitior, pravibismane, in patients with moderate to severe infected diabetic foot ulcers. Results were presented at the 2019 Symposium on Advanced Wound Care Fall Meeting.
“Topical pravibismane, or MBN-101, shows promise to improve outcomes and the quality of life of patients with chronic diabetic foot ulcers that are infected or colonized with bacteria,” said Dr. Paul Kim, Professor Department of Plastic Surgery and Orthopedic Surgery, Medical Director of the Wound Program at William P. Clements Jr. University Hospital. “The potential to prevent amputations and close wounds with pravibismane would be a significant benefit to patients and requires further study.”
The randomized, double blind, placebo-controlled Phase 1b trial evaluated topically applied pravibismane (MBN-101) plus standard of care treatment, versus placebo plus standard of care treatment, in 52 patients with moderate to severe diabetic foot ulcer infection. MBN-101 was well tolerated and no Treatment Emergent Adverse Events (TEAEs) or Serious Adverse Events (SAEs) occurring in the study were considered related to study drug.
Although the study was not designed to demonstrate statistical efficacy, a numerical trend of greater median wound size reduction and reduced amputation rate with MBN-101 treatment was observed compared to placebo.
· The median percent reduction in ulcer wound size from baseline was approximately 3-fold higher in the pooled MBN-101 group (85% wound size reduction) compared to placebo (29% wound size reduction) at End of Study (defined as 4 weeks after end of treatment).
· Target ulcer-related amputation in the pooled MBN-101 treatment groups were 2.6% vs 15.4% for placebo, an approximate 6-fold reduction.
There was no evidence of pravibismane systemic exposure and no differences in resolution of infection signs and symptoms across treatment groups.
“These are very encouraging data that support further, continued evaluation of pravibismane for chronic wounds,” said Dr. Brett Baker, Microbion’s Chief Scientific Officer and President. “We look forward to working with the FDA and other stakeholders on the continued development of this program towards its approval. We would like to deeply thank all the patients and investigators who participated in this important study.”
Subsequent to sharing the above data with the US FDA, Microbion has received guidance on development required to bring topical pravibismane towards approval.
Microbion is a clinical-stage biopharmaceutical company that is developing pravibismane as the first product in a new class for the local treatment of antibiotic-resistant and difficult to treat infections. Pravibismane has broad spectrum, antibacterial efficacy against a broad range of pathogens, including multiple priority pathogens or “superbugs” identified by the US CDC. In addition to antibacterial efficacy, pravibismane has also demonstrated the ability to eradicate microbial biofilms. This dual antimicrobial action from this first-in-class microbial bioenergetic inhibitor provides a much-needed novel clinical approach to treat infections. Microbion has been granted QIDP and Fast Track designations for multiple indications by US FDA.
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.
Director, Business Operations