Microbion Corporation has announced results from a Phase 1b trial of its microbial bioenergetic inhibitor, pravibismane, in patients with moderate to severe infected diabetic foot ulcers (DFUs). The findings of the trial were presented at the Symposium on Advanced Wound Care Fall meeting (SAWC Fall 2019; 12–14 October, Las Vegas, USA).
“Topical pravibismane, or MBN-101, shows promise to improve outcomes and the quality of life of patients with chronic DFUs that are infected or colonized with bacteria,” said Paul Kim, professor Department of Plastic Surgery and Orthopedic Surgery, and medical director of the Wound Programme at William P. Clements Jr. University Hospital, Dallas, USA. He added: “The potential to prevent amputations and close wounds with pravibismane would be a significant benefit to patients and requires further study.”
The randomised, double-blinded, placebo-controlled Phase 1b trial evaluated topically applied pravibismane (MBN-101) plus standard of care treatment, as compared to placebo plus standard of care treatment, in 52 patients with moderate to severe DFU infections. MBN-101 was well tolerated and no Treatment Emergent Adverse Events (TEAEs) or Serious Adverse Events (SAEs) occurring in the study were considered to be 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.
Furthermore, the median percentage reduction in ulcer wound size from baseline was approximately three-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 four 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 six-fold reduction, and there was no evidence of either pravibismane systemic exposure or any 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 Brett Baker, chief scientific officer and president of Microbion. “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 also received guidance on development required to bring topical pravibismane towards approval.