Microbion’s pravibismane anti-infective also wins funding from Cystic Fibrosis Foundation
(BOSTON: May 28, 2020) – CARB-X announced today it is awarding Microbion Corporation of Bozeman, MT, USA, up to $6.1 million plus up to $5.4 million more if certain project milestones are met, to develop its anti-infective drug pravibismane for the treatment of cystic fibrosis (CF)-related pulmonary infections.
The research 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.
“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.
The funding from CARB-X, along with a separate award announced today of up to $5.6 million from the Cystic Fibrosis Foundation, will help Microbion further explore the potential of pravibismane to kill drug-resistant bacteria and their biofilms and test its safety as an inhaled treatment for people with CF. If the results are positive, the anti-infective could next move into clinical development to test its effectiveness.
People with CF are susceptible to chronic infections due to abnormally thick, sticky mucus in their lungs which traps bacteria in the airways. These bacteria often form colonies surrounded by a protective outer layer known as biofilms, a community of bacteria that adheres to surfaces and is able to cause chronic infections. Biofilms tend to allow bacteria to both evade the immune system and become more resistant to antibiotics. At least 80 percent of infections involve bacteria that have formed biofilms, according to the National Institutes of Health, making biofilms an important target when fighting hard-to-treat infections.
Karim Lalji, Microbion’s Chairman, said: “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.”
In laboratory tests, Microbion’s drug candidate pravibismane was shown to kill drug-resistant bacteria and their biofilms, including those that pose a higher risk for people with CF such as multi-drug resistant Pseudomonas aeruginosa and nontuberculous mycobacteria (NTM).
The US Food and Drug Administration (FDA) has given the project Orphan Drug Designation, as well as Qualified Infectious Disease Product (QIDP) and Fast Track designations for inhaled pravibismane for the treatment (management) of pulmonary infections in patients with cystic fibrosis. Cystic fibrosis lung disease, estimated to affect more than 30,000 in the US and 70,000 worldwide, is characterized by infection and severe inflammation that lead to progressive deterioration in lung function. The disease represents a major health-care burden, responsible for reduced quality of life, morbidity, and premature mortality.
Supporting innovation to address the global superbug crisis
The CARB-X portfolio is the world’s largest and most diverse antibacterial development portfolio with 40 active projects – antibiotics, vaccines, rapid diagnostics and other life-saving products – in five countries focused on addressing the global rise of drug-resistant bacteria.
CARB-X, led by Boston University and funded by a global partnership, is investing up to $500 million between 2016-2021 to support the development of new antibiotics, rapid diagnostics, vaccines and other life-saving products that address drug-resistant bacteria. The goal is to support projects through the early phases of development – from hit-to-lead through Phase 1 for therapeutics – so that they will attract additional private or public support for further clinical development and approval for use in patients.
Since its launch in 2016, CARB-X has announced 62 awards exceeding $235.7 million, with the potential of additional funds if project milestones are met, to accelerate the development of antibacterial products. These funds are in addition to investments made by the companies themselves. The CARB-X pipeline will continuously evolve, as projects progress and others fail for a variety of reasons.
The CF Foundation’s commitment to antibiotic development
In 2018, the CF Foundation dedicated $100 million through 2023 to their Infection Research Initiative as part of a sweeping effort to advance infection research. Currently, the CF Foundation is funding 12 new industry programs to develop treatments for CF-related infections.
This news release is supported by the Cooperative Agreement Number IDSEP160030 from ASPR/BARDA and by award from Wellcome Trust and Germany’s Federal Ministry of Education and Research (BMBF). The contents are solely the responsibility of the authors and do not necessarily represent the official views of the HHS Office of the Assistant Secretary for Preparedness and Response, or other CARB-X funders.
Guy Cipriani, Chief Business Officer
Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) is a global non-profit partnership dedicated to accelerating early development antibacterial R&D to address the rising global 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). A non-profit partnership, CARB-X is investing up to $500 million from 2016-2021 to support innovative antibiotics and other therapeutics, vaccines, and rapid diagnostics. CARB-X supports the world’s largest and most innovative pipeline of preclinical products against drug-resistant infections. CARB-X is headquartered at Boston University School of Law. carb-x.org/. Follow us on Twitter @CARB_X.
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 is advancing pravibismane in clinical trials for two other infectious 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.
For more information visit: www.microbioncorp.com.
About BARDA and NIAID
The US Department of Health and Human Services works to enhance and protect the health and well-being of all Americans, providing for effective health and human services and fostering advances in medicine, public health, and social services. Within HHS, ASPR’s mission is to save lives and protect Americans from 21st century health security threats. ASPR leads the nation’s medical and public health preparedness for, response to, and recovery from disasters and public health emergencies. BARDA provides a comprehensive, integrated, portfolio approach to the advanced research and development, innovation, acquisition, and manufacturing of medical countermeasures – vaccines, drugs, therapeutics, diagnostic tools, and non-pharmaceutical products for public health emergency threats. These threats include chemical, biological, radiological, and nuclear agents, pandemic influenza, and emerging infectious diseases. NIH is the primary US federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. NIAID conducts and supports research — at NIH, throughout the United States, and worldwide — to study the causes of infectious and immune-mediated diseases, and to develop better means of preventing, diagnosing and treating these illnesses.
About Wellcome Trust
Wellcome exists to improve health for everyone by helping great ideas to thrive. We’re a global charitable foundation, both politically and financially independent. We support scientists and researchers, take on big problems, fuel imaginations and spark debate. The Wellcome Trust is a charity registered in England and Wales, no. 210183. Its sole trustee is The Wellcome Trust Limited, a company registered in England and Wales, no. 2711000 (whose registered office is at 215 Euston Road, London NW1 2BE, UK).
Education and research are the foundations for our future. The promotion of education, science and research by the Federal Ministry of Education and Research (BMBF) represents an important contribution to securing Germany’s prosperity. Education and research are a Federal Government policy priority, which is reflected in the development of the funding it is making available to these fields.
About Boston University
Founded in 1839, Boston University is an internationally recognized institution of higher education and research. With more than 33,000 students, it is the fourth-largest independent university in the United States. BU consists of 17 schools and colleges, along with a number of multi-disciplinary centers and institutes integral to the University’s research and teaching mission. In 2012, BU joined the Association of American Universities (AAU), a consortium of 62 leading research universities in the United States and Canada. For further information, please contact Jeremy Thompson at firstname.lastname@example.org. www.bu.edu.