What is pharma doing about the impending antibiotic resistance “apocalypse?”
We are entering the “antibiotic apocalypse.”
At least that’s the phrase used by England’s chief medical officer, Sally Davies, DBE, FMedSci, FRS, to describe the current situation regarding the growing problem of resistance. Dr. Davies made the comment in response to findings, initially presented at the American Society of Microbiology’s annual meeting and published in February in the journal Antimicrobial Agents and Chemotherapy (AAC), that bacteria containing the gene MCR-1 confers resistance to the antibiotic colistin.
As the authors of the AAC paper note, colistin is generally considered an “antibiotic of last resort,” and the discovery of the resistance conferred by the MCR-1 gene could mean that routine surgical procedures and hospitalizations would suddenly become fraught with peril due to the increased risk for resistant infections. According to the report “Antimicrobial Resistance: Tackling a Crisis for the Health and Wealth of Nations,” some 700,000 people worldwide die each year from infections that no longer respond to antibiotics; that number, the report suggests, could rise to 10 million by 2050.
Of course, the Centers for Disease Control and Prevention (CDC) has also sounded the alarm on this issue.
A commentary published on October 16, 2017, in Forbes laments that, “Traditional drug development methods take time and are insufficiently profitable to entice pharmaceutical companies to develop new antibiotics—which is why no pharmaceutical company has developed and marketed a new antibiotic in the last 30 years.”
But while the first part of that assertion may be true, the last part is arguably misleading. In fact, the US Food and Drug Administration (FDA) has approved several novel antibiotics in recent years, and there are multiple compounds currently in the pipeline. Still, these new innovations may not be enough to stem the tide of resistance. Hence, as reported by The Guardian on October 20, 2017, several research teams are actively engaged in projects seeking to reformulate and repurpose existing antibiotics. For example, a team at the Scripps Institute has developed a drug they call vancomycin 3.0, which they say is 25,000 times more potent than the original.
The only problem: Finding an affordable way to mass-produce the drug.
In early 2016, more than 80 drug companies signed a declaration in support of innovations designed to curb resistance. To date, several companies—some of them upstarts—have engaged in the battle. Therapix Biosciences, for example, which specializes in cannabinoid-based treatments, is currently exploring the development of a compound combining a cannabinoid with an existing antibacterial agent. And, MotifBio, is in the process of developing a novel antibiotic, Iclaprim, for acute bacterial skin and skin structure infections. The drug has a unique mechanism of action, according to the company, which may make it more effective than existing antibiotics against resistant infections. Trials are ongoing.
And, Iterum Therapeutics is developing sulopenem, an oral and IV antibiotic to treat drug-resistant gram-negative infections. Phase 3 trials are expected to begin next year.
Finally, on October 23, 2017, the FDA granted Cosmo Pharmaceuticals, manufacturers of Aemcolo (Rifamycin SV MMX) for travelers’ diarrhea, Qualified Infectious Disease Product (QIDP) and Fast Track designations for the drug. Phase 3 trials of the drug have already been completed.
Will these innovations be enough to prevent the “antibiotic apocalypse?” Probably not, which is why the United Nations Conference on Trade and Development (UNCTAD) has advocated for governments effectively incentivizing pharmaceutical companies to encourage the continued development of novel therapeutics.
“Although there are already public-private partnerships to develop new antibiotics, these are mostly ad hoc and focus on making drugs for very specific diseases and treatments,” said UNCTAD legal officer Christoph Spennemann. “While this is a step in the right direction, these partnerships are addressing very specific diseases, not the broader issue of global resistance. For this, you need government commitment to provide the industry—or the product-development partnership in charge of making the antibiotics—with a constant stream of funding. The lack of public funding for the phase after a new drug is approved—the ‘stewardship’ phase—may explain why fewer and fewer companies continue to invest in the old class of antibiotics, those already on the market.”
We know money “makes the world go ’round.” We’ll see if it stops it from ending.
Brian P. Dunleavy is a medical writer and editor based in New York. His work has appeared in numerous healthcare-related publications. He is the former editor of Infectious Disease Special Edition.