Moving to Non-Traditional Antibiotics

An event held in Washington D.C on June 14, 2018 convened by the Duke-Robert J. Margolis, MD, Center for Health Policy at Duke University and supported by a cooperative agreement with FDA, focused on the topic “Understanding the Development Challenges Associated with Emerging Non-Traditional Antibiotics”.

In the U.S more than two million people are infected with resistant bacteria annually and an estimated 23,000 die as a direct result. The combined direct cost of treatment and cost of lost productivity has been estimated in the tens of billions. Antimicrobial Resistance (AMR) is a serious and growing global threat. As a response to frequent antibiotic use, bacteria are likely to develop resistance against most known antibiotic therapies.

The National Institute for Allergy and Infectious Diseases (NIAID) has allocated tens of millions of dollars toward combating antibiotic resistance. NIAID is funding the development of non-traditional antibiotics, developing an antibacterial resistance clinical research network, and developing tools to advance antibiotic discovery to rapidly diagnose antimicrobial resistance.

Ed Cox, as Director of the FDA Office of Antimicrobial Products, oversees the review, approval, and safety of antimicrobial drugs, and immunosuppressive agents for patients who have received solid organ transplants.

He mentioned how FDA Commissioner Scott Gottlieb MD., issued a statement on FDA’s efforts to foster discovery and development of new tools to fight antimicrobial-resistant infections. The Commissioner pointed out how FDA encourages the development of new therapeutic options.

FDA has issued draft guidance on the “Limited Population Pathway for Antibacterial and Antifungal Drugs” or referred to as the LPAD pathway which was established by Congress under the 21st Century Cures Act. The agency is also taking additional steps towards strengthening the fragile antibacterial drug pipeline as part of the larger effort to combat antibiotic-resistant bacteria.

Greg Meril, CEO Adaptive Phage Therapeutics (APT), a company founded to provide an effective therapeutic response to the global rise of multidrug MDR pathogenic bacteria. Phage is short for bacteriophage which is a virus living within a bacteria.

Because many bacteriophages kill the bacterial cells they infect, phages possibly can provide a possible alternative to antibiotics. As Meril explained, “The frequency of antibiotic resistant bacteria has increased and as a result, there is a renewed interest in phage therapy.”

Other actions are being conducted by CARB-X, https://carb-x-org a public-private partnership headed by Kevin Outterson. He directs the nonprofit partnership at Boston University-based CARB-X established to support the development of innovative antibiotics, vaccines, and other products to fight superbugs.

CARB-X was launched two years ago by HHS to give financial, scientific, and business support to small companies focusing on drug resistant bacteria.  It was recently announced that more than $500 million is available to CARB-X to use to develop products to protect people from superbug bacterial infections.

CARB-X existing funding partners include the HHS Biomedical Advanced Research and Development Authority (BARDA) which has committed $250 million over five years, NIAID has committed $50 million in preclinical services over five years along with the Wellcome Trust, Bill and Melinda Gates Foundation, and the Government of the UK providing additional financial assistance.

Paul Garofolo, Co-Founder and CEO of Locus Bioscience, a biotechnology company focused on developing the next generation CRISPR-Cas platform that has the capability to protect bacteria from invaders such as viruses.

The CRISPR-Cas platform enables the design and development of powerful antimicrobials that avoid currently known antibiotic resistance mechanisms while leaving non-target bacteria unharmed. The company is advancing the platform to create therapeutics for critical disease areas ranging from resistant bacterial infections to the microbiome.

As explained by Alan Joslyn, CEO and President of Oragenics Inc.  “Oragenics is currently developing their antibiotic product candidate OG716 and also researching other homolog antibiotic product candidates. These candidates include Lantibiotics a class of antibiotics with a novel mechanism of action active against several multi-drug resistant organisms which are now in the preclinical phase.”


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