BOZEMAN, Mont., May 28, 2020 /PRNewswire/ -- Microbion Corporation of Bozeman, Montana today announced it has been awarded up to US$17.1 million from CARB-X and the Cystic Fibrosis Foundation to advance the development of its antimicrobial drug pravibismane for the treatment of cystic fibrosis (CF)-related pulmonary infections.
The $11.5 million in funding from CARB-X and the up to $5.6 million in funding from the CF Foundation will enable Microbion to complete preclinical and Phase 1 studies. The CARB-X funding will also support manufacturing pravibismane drug product for clinical studies.
"Microbion's new class of anti-infective represents a novel drug that has shown potent activity against antibiotic-resistant bacterial pathogens and the biofilms these pathogens produce. Microbion's pravibismane, if successful and eventually approved for use in patients, has the potential to be a critical new weapon in the fight against chronic and resistant infections," said Erin Duffy, Chief of Research and Development of CARB-X.
This project is CARB-X's first award for the development of an inhaled antibiotic to treat chronic lung infections and potentially infections in people living with CF. The award is comprised of an initial commitment of up to $6.1 million plus up to $5.4 million more if certain project milestones are met.
"Infection is a top concern of both patients and CF clinicians and remains a leading cause of lung function loss among people living with cystic fibrosis," said William Skach, Chief Scientific Officer, Cystic Fibrosis Foundation. "As people with CF increasingly combat chronic infections and antibiotic resistance, now, more than ever before, we need novel, safe and effective anti-infectives."
"We are grateful for this significant support from CARB-X and the Cystic Fibrosis Foundation to investigate inhaled pravibismane as a novel approach for the management of chronic respiratory and antibiotic-resistant infections," said Karim Lalji, Microbion's Chairman. "Beyond their investment, these organizations' expertise in antibiotic-resistant infections, particularly those associated with CF, will prove valuable to advancing our technology as part of a much-needed solution to address the chronic and intractable infections that are a hallmark of CF."
Pravibismane is the first in a new class of anti-infective drugs structurally unrelated to other clinically utilized antibiotics, with a mechanism of action that functions as a microbial bioenergetic inhibitor. In pre-clinical studies, pravibismane exhibits broad-spectrum, potent, and persistent antimicrobial and anti-biofilm activity against CF-relevant pathogens including carbapenem- and multidrug-resistant Pseudomonas aeruginosa, as well as other multidrug-resistant pathogens and their related biofilms.
Pravibismane's potential activity against bacterial biofilms is also a key differentiator. Microbial biofilms play a key role in the chronic nature of the pulmonary infections in people with CF and are known to contribute to the antibiotic-resistance of these infections. Addressing the biofilm component of these infections represents a unique strategy in the treatment of chronic, resistant infections. Critically, lab tests have shown that pravibismane retains its activity in CF sputum.
The US FDA has granted Microbion Orphan Drug Designation, as well as QIDP and Fast Track designations for inhaled pravibismane for the treatment (management) of pulmonary infections in patients with cystic fibrosis.
About Infection and Cystic Fibrosis
Cystic Fibrosis (CF) lung disease, which is estimated to affect more than 30,000 in the US and 70,000 worldwide, is characterized by chronic bacterial infection and severe inflammation that lead to progressive deterioration in lung function. Chronic pulmonary infections in CF patients, a significant portion of which involve Pseudomonas aeruginosa, are characterized by persistence, biofilm formation, evasion from immune responses, and resistance to multiple therapeutic agents. Furthermore, patients co-infected with additional CF-relevant bacteria resulting in multispecies biofilms have demonstrated greater resistance, virulence, and pathogenicity compared to single-species biofilms, thereby complicating treatment. Biofilms protect bacteria from traditional antibiotics as well as the host immune system, and they are implicated in the persistence of lung infections despite long-term therapeutic intervention. Chronic, CF-related pulmonary infections represent a major health care burden, being responsible for significant loss of productivity, reduced quality of life, morbidity, and premature mortality.
Microbion is a clinical-stage biopharmaceutical company developing pravibismane as the first product in a new class of anti-infective drugs with a mechanism of action that functions as a microbial bioenergetic inhibitor for the local treatment of antibiotic-resistant and difficult to treat infections. Pravibismane has antibacterial efficacy against a broad spectrum 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 may offer a much-needed, novel, clinical approach to treat infections. Microbion has been granted QIDP and Fast Track designations for multiple indications and Orphan Drug Designation for the treatment (management) of pulmonary infections in patients with cystic fibrosis by the US FDA. In addition, Microbion has completed two clinical trials of pravibismane in diabetic foot ulcer (DFI) and orthopedic implant-related infections and is continuing the clinical advancement of pravibismane for these indications. The International Nonproprietary Name (INN) recommended by the WHO of pravibismane is the first member in the bismane class which represents a novel class of anti-infective drugs. Microbion Corporation has previously closed a Series A financing of US$25M from GHS Fund (Quark Venture LP and GF Securities).
CARB-X (Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator) is a global non-profit partnership dedicated to supporting early development antibacterial R&D to address the rising threat of drug-resistant bacteria. CARB-X is led by Boston University and funding is provided by the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response (ASPR) in the US Department of Health and Human Services; the Wellcome Trust, a global charity based in the UK working to improve health globally; Germany's Federal Ministry of Education and Research (BMBF); the UK Department of Health and Social Care's Global Antimicrobial Resistance Innovation Fund (GAMRIF); the Bill & Melinda Gates Foundation, and with in-kind support from National Institute of Allergy and Infectious Diseases (NIAID), part of the US National Institutes of Health (NIH) within the US Department of Health and Human Services. CARB-X is investing up to US$500 million from 2016-2021 in the development of innovative antibiotics and other therapeutics, vaccines and rapid diagnostics. CARB-X focuses exclusively on high priority drug-resistant bacteria, especially Gram-negatives. CARB-X is headquartered at Boston University School of Law. https://carb-x.org/. Follow us on Twitter @CARB_X
Disclaimer:Research reported in this press release is supported by the Cooperative Agreement Number IDSEP160030 from ASPR/BARDA and by awards from Wellcome Trust and Germany's Federal Ministry of Education and Research, as administrated by CARB-X. The content is solely the responsibility of the authors and does not necessarily represent the official views of the Department of Health and Human Services Office of the Assistant Secretary for Preparedness and Response, other funders, or CARB-X.
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.