Why Aren’t More Biotechnology Companies Creating New Antibiotics?

Antimicrobial Resistance

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Infection prevention and control personnel face a continuous threat from antimicrobial resistance which can make it difficult to fight various pathogens. The absence of antibiotics poses a significant challenge for clinicians and patients in dealing with infections, some of which can be fatal. Despite the need for antibiotics, there is a lack of new antibiotics being developed.

This interview with Joseph Hernandez, MSc, MBA, MS, and the CEO of Blue Water Biotech Inc, the CEO of Blue Water Biotech, by Infection Control Today^® (ICT^®) sheds light on strategies to address antimicrobial resistance and the possibility of not requiring additional antibiotic development.

ICT: Infection Control Today covers antimicrobial resistance often. Is your company working on creating a new antibiotic?

Joseph Hernandez, MSc, MBA, MS: Antimicrobial resistance is an aspect that we're collaborating with St. Jude's to combat with our strep pneumo vaccine for acute otitis media. For acute otitis media, the challenge is the over-prescription of antibiotics, especially in kids. As you know, the first encounter, usually in the pediatrician's office, is with a kid who has an ear infection. And the modality of treatment is always the same. It's an antibiotic. These kids get exposed to antibiotics early on, and we [Blue Water Biotech, Inc] think this is the genesis for many of the antimicrobial resistance we see. We have very, very few tools to fight these organisms. And the more we prescribe, the [fewer] tools we have. So, it's a double-edged sword.

JH: And the other [reason few antibiotics are created] is that we have another dynamic happening in the marketplace. Pharmaceutical companies, including biotechs, are not incentivized to develop microbial programs because of favorable economics. As a society, we need to think through that better. By overprescribing antibiotics, we're creating organisms that aren't impacted by these antibiotics, and we're not investing in new antibiotics, posing a real challenge. At some point, our governmental agencies, funders, and investment community must pay attention to that because it's a real issue.

ICT: It isn’t fiscally feasible?

JH: It is] the development costs. If you think about it, there's a lot of logic in it, right? The development cost of an antibiotic is no different from developing a long-term cardiovascular or biologic for cancer. Those drugs are taken for a very long period vs an antibiotic that someone can take for a few days. The economic returns are not there on a 4-day regimen versus a lifelong therapy. And the only way to address it is through the governmental agencies. The US Food and Drug Administration needs to get involved in this and change the dynamic. The reimbursement, the payer side of the equation, must pay a premium for these products as they're revolutionary. There are many of them sitting on the shelf waiting to be developed beyond the initial discovery phase. We haven't developed real breakthrough antibodies in a very long time. So, as an industry we need to get to work.

There is no easy solution. If you've had the pleasure of being in a hospital, Clostridioides difficileinfections, methicillin-resistant Staphylococcus aureus (MRSA), and pneumonia infections are very prevalent, and their tools are limited.

Both C difficile and MRSA can be challenging to treat, as are some of these crazy, antibiotic-resistant pathogens. These bugs have been around longer than we have. They develop mechanisms to survive, evolve, and evade immune systems. We must keep the battle going, which requires a lot of knowledge and resources, and develop creative ways to ensure new products get to the market. While next-generation antibiotics are needed to treat infections, our strep pneumo vaccine is designed to prevent disease in the first place. By preventing infection and disease, we will decrease the need for antibiotic treatment and limit the possibility that these bugs can evolve to be resistant to traditional antibiotics.

(This interview has been edited for clarity.)