Microbion's Topical Pravibismane Phase 1b Moderate or Severe Diabetic Foot Ulcer Infection Study is Published in International Wound Journal

• Topical pravibismane was found to be safe and well-tolerated for all doses tested in subjects with moderate to severely infected, chronic diabetic foot ulcers
• Pravibismane treatment demonstrated favorable trends towards greater reduction of ulcer size and lower incidence of ulcer-related lower limb amputations compared to placebo

BOZEMAN, Mont. and VANCOUVER, BC, April 4, 2024 /PRNewswire/ - Microbion Corporation today announced that the company has published results from its topical pravibismane Phase 1b study in the peer-reviewed International Wound Journal. The manuscript titled "Topical Pravibismane as Adjunctive Therapy for Moderate or Severe Diabetic Foot Infections: A Phase 1b Randomized, Multi-Center, Double-Blind, Placebo-Controlled Trial" is available for free download at International Wound Journal's website (https://doi.org/10.1111/iwj.14817). The main objective of the study was to assess the safety and tolerability of adjunctive administration of topical pravibismane added to standard of care, for 2 to 3 weeks, for subjects with moderate or severely infected chronic diabetic foot ulcers (DFI). Though the study was not powered to demonstrate statistical efficacy, positive trends signalling clinical efficacy were demonstrated with pravibismane (versus placebo [vehicle]) added to standard of care, including greater reduction in wound area and lower amputation risk versus vehicle. Pravibismane is the first product in a new class of compounds that has a unique triad of novel modes of action, including potent broad spectrum anti-infective, antibiofilm, and immuno-modulatory activity.

"We are excited to share the results of this Phase 1b study that was designed mainly to assess the safety of topical pravibismane administration to DFI patients," said Dr. Benjamin A. Lipsky, Professor of Medicine Emeritus at University of Washington, and the primary author of the manuscript. "We are pleased with the safety results and signals of clinical efficacy, which we believe warrant further clinical development of pravibismane in future studies. There is currently a major unmet need for new, easy to apply drug agents with multiple modes of activity to treat infection, and possibly help close, these infected, chronic wounds."

"We are encouraged by the clinical efficacy signals demonstrated with pravibismane administration, such as greater wound size reduction, compared to placebo control," said Dr. David G. Armstrong, Professor of Surgery at the Keck School of Medicine of University of Southern California, and co-author of the manuscript. "Diabetic foot ulcers more than double a person's mortality risk that year and dramatically reduce quality of life. Occurrence of infections, especially antibiotic-resistant infections, within a chronic, persistent foot ulcer increases the risk of sepsis, and makes the ulcer even more difficult to treat, especially with the presence of infectious biofilms. We need new agents that promote faster closing of infected wounds because we are currently dependant on an expensive, time-consuming, two-pronged approach: firstly, use of systemic antibiotics to clear the infection; and then secondly, another agent, device, or advanced cellular or tissue therapeutic to attempt to close the wound."

"We are pleased to have published the safety and efficacy results from this Phase 1b study," said Dr. Brett Baker, Microbion's President, Chief Innovation Officer and co-author of the manuscript. "Pravibismane is consistently demonstrating safety and tolerability, which is a primary consideration for any drug. Importantly, it appears that pravibismane's triple activity of anti-microbial, anti-biofilm and immune-modulatory activity may be important to promote wound closure and restoration of the primary barrier of the skin. This therapeutic objective is currently being assessed in our recently completed, 12-week Phase 2 study in moderately infected, chronic diabetic foot ulcers."

The published manuscript describes in detail the Phase 1b study that was designed to evaluate the safety and efficacy of pravibismane in managing moderate or severe chronic diabetic foot ulcer infections. The study consisted of 39 individuals undergoing pravibismane treatment (in adjunct to standard of care) and 13 individuals in the placebo group (in adjunct to standard of care). In the study, pravibismane was well-tolerated, exhibited minimal systemic absorption, and was not associated with any treatment-emergent or serious adverse events. Pravibismane treated subjects showed an approximately 3-fold reduction in ulcer size compared to the placebo group (85% versus 30%). Furthermore, the incidence of diabetic ulcer-related lower limb amputations was approximately 6-fold lower in the pooled pravibismane group compared to the placebo group (2.6% versus 15.4%). The study results suggests that topically applied pravibismane has the potential to address the unmet need of a new DFI treatment that can simultaneously treat bacterial biofilm-related infections and accelerate ulcer size reduction, potentially leading to complete re-epithelialization and wound closure along with reduction of reinfection and amputation risks.

A Phase 2 study with the main objective of assessing the safety and tolerability of a higher concentration and longer, 12-week dosing duration of topical pravibismane in patients with moderately infected chronic diabetic foot ulcers was recently completed. While the primary endpoint is to assess safety and tolerability, secondary efficacy objectives include complete wound closure.

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, antibiofilm, and immuno-modulatory activity, offering unique potential to address the unmet needs of chronic and severe health conditions. Topical pravibismane is completing Phase 2 development for the treatment of chronic wounds. Local pravibismane is in Phase 2 clinical development for orthopedic infections and inhaled pravibismane is advancing into Phase 1 clinical development for the treatment of chronic lung diseases, including non-tuberculous mycobacteria (NTM) and cystic fibrosis-related lung infections. Pravibismane has received backing from the Cystic Fibrosis Foundation, NIH, US DoD, and CARB-X with over $20 million in non-dilutive grants. The FDA has granted pravibismane Orphan Drug, Fast Track, and Qualified Infectious Disease Product (QIDP) designations.

For more information visit: www.microbioncorp.com.

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 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 any future product candidates and our ability to serve those markets; our ability to obtain and maintain regulatory approval of pravibismane or any future product candidates; and our expectations regarding the potential safety, efficacy or clinical utility of pravibismane 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.

SOURCE Microbion Corporation