A Randomized, Open Label, Controlled, Phase 2, Multi-Center Study to Assess Safety, Tolerability and Efficacy of Adjunctive Treatment With Topically Applied MBN-101 (Pravibismane Topical Suspension) in Subjects With Moderate Diabetic Foot Infection (DFI)

This is a randomized, open label, controlled, multi-center study to assess safety, tolerability, and efficacy of adjunctive treatment with topically applied pravibismane (MBN-101) in patients with moderate diabetic foot infections. Patients will be randomized in a 2:1 ratio (MBN-101:standard of care). Topical pravibismane (MBN-101) will be applied three times per week for up to 12 weeks. All patients will receive systemic antibiotic treatment for a least a portion of that period. Randomization will be stratified by site.

Start Date13 Jun 2022

Sponsor / Collaborator

Microbion Corp.

[+2]

NCT02723539 / CompletedPhase 1

A Phase 1b/2a Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety, Tolerability and Efficacy of Adjunctive Treatment With Topically Applied MBN-101 in Patients With Moderate to Severe Diabetic Foot Infection (DFI)

This is a randomized, double-blind, placebo-controlled, multi-center study, in patients with moderate to severe diabetic foot infection (DFI), that will be conducted in two parts. In Part I, patients will be enrolled into 1 of 3 escalating dose cohorts at a ratio of 3:1 (Active to Placebo). In Part II, patients will be randomized in a 1:1 ratio (Active to Placebo) based on the optimal dose demonstrated in Part I. Patients will be randomized to receive either topical application of MBN-101 or topical application of vehicle, applied directly to the target site, 3 times per week, for a minimum of 14 days and up to a maximum of 21 days. All patients will also receive systemic antibiotic treatment.

Start Date06 Mar 2017

Sponsor / Collaborator

Microbion Corp.

NCT02436876 / CompletedPhase 2

Phase 2a Randomized, Single-Blind, Placebo-Controlled, 12-week Escalating Dose Study to Assess the Safety, Tolerability and Clinical Activity of 3 Concentrations of Locally Applied MBN-101 to Infected Bone Sites

This study evaluates the safety and clinical benefit of MBN-101 administered intraoperatively to osteosynthesis or osteomyelitis sites for patients diagnosed with an orthopedic infection, with or without orthopaedic hardware. Three quarters of the patients will receive MBN-101, while the other one quarter will receive placebo.

Start Date24 May 2016

Sponsor / Collaborator

Microbion Corp.

[+4]

100 Clinical Results associated with Pravibismane

100 Translational Medicine associated with Pravibismane

100 Patents (Medical) associated with Pravibismane

Literatures (Medical) associated with Pravibismane

01 Apr 2024·International Wound Journal

Topical pravibismane as adjunctive therapy for moderate or severe diabetic foot infections: A phase 1b randomized, multicenter, double‐blind, placebo‐controlled trial

Article

Author: McKernan, Patricia A. ; Kim, Paul J. ; Baker, Brett H. J. ; Lipsky, Benjamin A. ; Murphy, Brian ; Armstrong, David G.

AbstractThis Phase 1b study was designed to evaluate the safety and efficacy of pravibismane, a novel broad‐spectrum topical anti‐infective, in managing moderate or severe chronic diabetic foot ulcer (DFU) infections. This randomized, double‐blind, placebo‐controlled, multicenter study consisted of 39 individuals undergoing pravibismane treatment and 13 individuals in the placebo group. Assessment of safety parameters included clinical observations of tolerability and pharmacokinetics from whole blood samples. Pravibismane was well‐tolerated and exhibited minimal systemic absorption, as confirmed by blood concentrations that were below the lower limit of quantitation (0.5 ng/mL) or in the low nanomolar range, which is orders of magnitude below the threshold of pharmacological relevance for pravibismane. Pravibismane treated subjects showed approximately 3‐fold decrease in ulcer size compared to the placebo group (85% vs. 30%, p = 0.27). Furthermore, the incidence of ulcer‐related lower limb amputations was approximately 6‐fold lower (2.6%) in the pooled pravibismane group versus 15.4% in the placebo group (p = 0.15). There were no treatment emergent or serious adverse events related to study drug. The initial findings indicate that topical pravibismane was safe and potentially effective treatment for improving recovery from infected chronic ulcers by reducing ulcer size and facilitating wound healing in infected DFUs (ClinicalTrials.gov Identifier NCT02723539).

01 Dec 2004·PeptidesQ3 · MEDICINE

BisEDT and RIP act in synergy to prevent graft infections by resistant staphylococci

Q3 · MEDICINE

Article

Author: Naomi Balaban ; Andrea Giacometti ; Fiorenza Orlando ; Moshe Korem ; Oscar Cirioni ; Roberto Ghiselli ; Philip Domenico ; Giorgio Scalise ; Ellen Gurzenda ; Vittorio Saba

Staphylococci are a major cause of infections associated with indwelling medical devices. Biofilm formation on these devices adds to the antibiotic resistance seen among clinical isolates. RNAIII-inhibiting peptide (RIP) is a heptapeptide that inhibits staphylococcal pathogenesis, including biofilm formation, by obstructing quorum sensing mechanisms. Bismuth ethanedithiol (BisEDT) also prevents biofilm formation at subinhibitory concentrations. RIP and BisEDT were combined to prevent infections in a rat graft model, using antibiotic sensitive and resistant strains of Staphylococcus aureus and Staphylococcus epidermidis. BisEDT, RIP, or rifampin, or their combinations reduced the graft associated bacterial load over seven days. BisEDT-RIP was the best combination, reducing bacterial load to undetectable levels. BisEDT-RIP may prove useful for coating medical devices to prevent staphylococcal infections.

01 Jun 2002·American Journal of Respiratory Cell and Molecular BiologyQ1 · MEDICINE

Subinhibitory Bismuth-Thiols Reduce Virulence ofPseudomonas aeruginosa

Q1 · MEDICINE

Article

Author: Kazzaz, Jeffrey A. ; Domenico, Philip ; Hauser, Alan R. ; Hassett, Daniel J. ; Wu, Chieh-Liang ; Beveridge, Terry J.

Pseudomonas aeruginosa is a common pathogen in mechanically ventilated patients and produces a wide array of virulence factors. Bismuth-thiols (BTs) are active in vitro against all bacterial lung pathogens, including P. aeruginosa. The objective of these studies was to examine the biochemical and morphologic effects of sublethal BT concentrations on P. aeruginosa and to evaluate virulence in cell culture. Bismuth-dimercaprol, at a fraction of the minimal inhibitory concentration, reduced alginate expression by 67% in P. aeruginosa, whereas subinhibitory bismuth-ethanedithiol (BisEDT) reduced alginate by 92% in P. syringae. BisEDT effects on lipopolysaccharide content and type III secreted cytoxins were examined by sodium dodecyl sulfate polyacrylamide gel electrophoresis. Subinhibitory BisEDT reduced cell-associated lipopolysaccharide, and inhibited processing of the secreted cytotoxic protein ExoU. BisEDT-induced outer membrane blebbing and aggregation of cytoplasmic material was noted in electron microscopy. Virulence of P. aeruginosa was assessed by adherence to epithelial cells and sensitivity to serum killing. BisEDT inhibited adherence of P. aeruginosa to 16HBE14o- cells by 28% and to a collagen matrix by 53%. BisEDT-treated bacteria were also 100-fold more sensitive to serum bactericidal activity. In summary, low BT concentrations affect P. aeruginosa in a variety of ways, the combination of which may help prevent or resolve respiratory tract infection.

News (Medical) associated with Pravibismane

15 Apr 2024

·www.biospace.com

Microbion Selected to Present at Advanced Wound Care Summit USA

Microbion is one of 6 finalists selected to present at the Advanced Wound Care Summit's Innovation Showcase session on April 17 BOZEMAN, MT and VANCOUVER, BC, April 15, 2024 /PRNewswire/ - Microbion Corporation today announced that the company has been selected to present topical pravibismane for the treatment of diabetic foot infection (DFI) at the Advanced Wound Care Summit USA held at the Boston Marriot Long Wharf from April 16th to 17th. Karim Lalji, Microbion's CEO, will be presenting during the Innovation Showcase portion of the summit on April 17 at 9:30am in the Grand Ballroom. The presentation will focus on topical pravibismane's clinical safety and efficacy for the treatment of moderate to severe DFI and future development plans. In a Phase 1b study in patients with moderate to severe DFI, pravibismane was well-tolerated and 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%). Topically applied pravibismane has the potential to address several unmet medical needs for the successful treatment of DFI by simultaneously treating bacterial biofilm-related infections and accelerating ulcer size reduction, potentially leading to complete re-epithelialization and wound closure along with reduction of reinfection and amputation risks. The company has recently completed a Phase 2 study assessing the safety, tolerability, and wound closure efficacy of a higher concentration and longer, 12-week dosing duration of topical pravibismane in patients with moderately infected chronic diabetic foot ulcers. About Microbion 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: . 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 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.

Phase 1Phase 2Fast TrackClinical ResultOrphan Drug

30 Jan 2024

·www.biospace.com

Microbion's Pravibismane Granted Second FDA Orphan Drug Designation for the Treatment of Non-tuberculous Mycobacterial (NTM) Infections

Second orphan drug designation granted for pravibismane, in addition to the treatment of pulmonary infections in patients with cystic fibrosis Pravibismane demonstrated statistically significant in vivo efficacy against NTM in chronic and acute infection models BOZEMAN, MT and VANCOUVER, BC, Jan. 30, 2024 /PRNewswire/ - Microbion Corporation today announced that the company has been granted a second orphan drug designation for its lead drug candidate, pravibismane, for the treatment of non-tuberculous mycobacterial (NTM) infections. NTM infections are most commonly found in the lungs; however, skin and soft tissue, indwelling medical devices, lymph nodes, and blood can also harbor NTM infections. "We are pleased that the FDA has granted pravibismane this second orphan drug designation for the treatment of NTM infections," said Dr. Jeff Millard, Microbion's Chief Scientific Officer. "Our in vitro and in vivo data for the activity of pravibismane against pulmonary NTM infections and related biofilms, demonstrate unique and highly differentiated, potent activity compared to other agents currently used to treat NTM, while being well tolerated. We look forward to working closely with all our stakeholders and patients to advance the development of pravibismane for the treatment of NTM infections." "This designation comes at an opportune time as Microbion plans to initiate a Phase 3 program for topical pravibismane treatment of chronic wounds and a Phase 1 program with inhaled pravibismane for treatment of NTM lung infections," said Karim Lalji, Chief Executive Officer. "In an in vivo study using a chronic NTM lung infection model, inhaled pravibismane demonstrated an over 18-fold reduction of M. abscessus, the most pathogenic and rapidly growing species, for which no approved therapy exists. We are encouraged by the potential of pravibismane to address the critical unmet need of NTM infections." The FDA has the authority to grant orphan drug designation to a drug or biological product to prevent, diagnose, or treat a rare disease or condition, defined as any disease or condition that affects fewer than 200,000 persons in the United States. Orphan drug designation qualifies Microbion for various development incentives of the Orphan Drug Act, including seven years of market exclusivity. About Microbion 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 anti-inflammatory 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 grants. The FDA has granted pravibismane Orphan Drug, Fast Track, and Qualified Infectious Disease Product (QIDP) designations. For more information visit: . 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 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.

Orphan DrugFast TrackPhase 2Qualified Infectious Disease ProductPhase 1

05 Oct 2023

·www.prnewswire.com

Microbion CEO to Participate in Panel Discussion at BioFuture 2023

Karim Lalji, CEO, will participate in panel discussion during BioFuture 2023, Infectious Disease: From Neglect to Respect Made Possible by New Technologies The Company will also present its new class of therapeutic compounds and clinical development programs targeting rare, chronic, and serious diseases BOZEMAN, Mont., Oct. 5, 2023 /PRNewswire/ - Microbion Corporation today announced that Karim Lalji, CEO, will participate in a panel discussion during BioFuture 2023. The panel discussion, entitled Infectious Disease: From Neglect to Respect Made Possible by New Technologies, will take place on Friday, October 6 at 3:00pm ET at Lotte New York Palace in New York. Microbion has also been selected as a presenting company at BioFuture 2023. Registered in-person attendees to BioFuture can view Microbion's presentation live at the following date and time. Date: Thursday, October 5, 2023 Time: 4:15pm ET Track: Kennedy I - Fourth Floor (Kennedy I) Mr. Lalji will present Microbion's new class of therapeutic compounds and clinical development programs for the treatment of rare, chronic, and serious diseases. The company's lead drug candidate, pravibismane, is the first drug in a new class demonstrating multiple, novel modes of activity including broad-spectrum potency against a wide range of bacterial pathogens, an unprecedented ability to eradicate biofilms, and an immunomodulatory effect via an unprecedented ability to modulate a critical cytokine involved in autoimmune and inflammatory diseases. Mr. Lalji will provide summary data demonstrating pravibismane's potential for addressing critical unmet medical needs and plans for initiating registrational studies in late 2024. "We are delighted to be participating in this important panel discussion on infectious disease at BioFuture," said Karim Lalji, Microbion's CEO. "We look forward to discussing the opportunities and challenges of drug development in this space and sharing some of our innovative approaches for successfully advancing several clinical-stage assets." "We are delighted that Microbion will be presenting at BioFuture," said Sara Demy, CEO of Demy-Colton. "BioFuture brings together today's very best innovators, investors and business leaders to discuss the forces shaping the future of healthcare and identify the potential game-changing technologies that will drive the future of drug discovery. We are excited to have Microbion participating in this important event." ABOUT MICROBION 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 anti-inflammatory activity, offering unique potential to address the unmet needs of chronic and severe health conditions. The Company is advancing topical/local pravibismane in Phase 2b development for the treatment of chronic wounds and orthopedic infections. Inhaled pravibismane is in Phase 1 clinical development for the treatment of chronic lung diseases, including non-tuberculous mycobacteria (NTM) and cystic fibrosis-related lung conditions. Pravibismane has received backing from the Cystic Fibrosis Foundation, NIH, US DoD, and CARB-X with over $20 million in grants. The FDA has granted pravibismane Orphan Drug, Fast Track, and QIDP designations. For more information visit: . ABOUT BIOFUTURE BioFuture, produced by Demy-Colton, is a conference convening future-focused healthcare thinkers, top investors, stakeholders and cutting-edge companies to "Reimagine the Future of Healthcare". BioFuture 2023 will be held in-person in New York City on October 4-6 at Lotte Palace Hotel, with a virtual access option for digital partnering and recorded content on October 10-12. BioFuture features multiple tracks of plenary sessions, presenting companies, workshops, networking, and an opportunity to schedule one-to-one meetings. BioFuture was founded by Demy-Colton, a leading life sciences and digital health events organization, with a long history of producing high-quality events that build networks between innovative life sciences companies and industry stakeholders. 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 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

Fast TrackPhase 1Orphan DrugPhase 2Microbial therapy

100 Deals associated with Pravibismane

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Indication	Highest Phase	Country/Location	Organization	Date
Diabetic foot infection	Phase 2	US	Microbion Corp.	13 Jun 2022
Mycobacterium Infections, Nontuberculous	Phase 1	US	Microbion Corp.	12 Jul 2021
Respiratory Tract Infections	Phase 1	US	Microbion Corp.	08 May 2019
Bacterial Infections	Phase 1	US	Microbion Corp.	24 May 2016

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05174806 (Company_Website) Manual	Phase 2	Diabetic foot ulcer	46	pravibismane	(qhzhojiylj) = No adverse events attributable to topical pravibismane. No treatment discontinuations due to drug-related intolerability. trmhhmgvkv (mcgnhybwja ) View more	Positive	13 Nov 2024
				standard of care alone
NCT02723539 (Pubmed) Manual	Phase 1	Diabetic foot infection	52	Pravibismane	kcknrfarkr(lhvvauvhso) = bjwgtmijsl btjuedkwct (aeadnbsncc ) View more	Positive	01 Apr 2024
				Placebo	kcknrfarkr(lhvvauvhso) = uwputvyexo btjuedkwct (aeadnbsncc ) View more
NCT02436876 (CTgov)	Phase 2	Bacterial Infections	29	Placebo+MBN-101 (Cohort 1)	gjckocfaks(dgsdpujxwj) = otkdtuyupd oaaevietuo (xqyjssdtok, mpyqpetqvy - ogwtpqxcoc) View more	-	30 Sep 2021
				Placebo+MBN-101 (Cohort 2)	gjckocfaks(dgsdpujxwj) = zraconkjvk oaaevietuo (xqyjssdtok, xwsnlvhlil - wofqirpunf) View more
NCT02723539 (Corporate Publications) Manual	Phase 1	Diabetic foot infection	52	Standard of Care+pravibismane	(dkvzmqshyb) = no Serious Adverse Events qpzhyayaqj (pmisjaekbz ) View more	Positive	28 Oct 2019
				Standard of Care+Placebo

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