Exploring How Biologic Therapy Can Have a Positive Impact on Public Health


biologic therapy
C. difficile has become the #1 threat to public health due to how difficult it is to prevent recurrence. Biologic therapy may provide an answer.
Image source: Flickr CC user RIGHT TO HEALTH

For years, the scientific community has warned about the dangers of overusing antibiotics. Initially viewed as a wonder drug, physicians took to prescribing them to address many types of bacterial infections. While this strategy appears sound, overuse has led to the evolution of “superbugs” against which most conventional antibiotics are ineffective.

The most well-known of these superbugs is most likely methicillin-resistant Staphylococcus aureus—or MRSA. MRSA gained notoriety as a hospital-acquired infection. But while the focus has been on MRSA for so long, another superbug has come along and taken its infamous crown: Clostridium difficile (C. difficile). Over the last two decades, however, the number of cases has risen sharply and the Centers for Disease Control recently labeled C.difficile an urgent public health threat.

During infection, C. difficile releases a toxin that causes inflammation and damages the gastrointestinal wall, leading to intense abdominal pain and diarrhea. Because of its status as a superbug, the only present way to treat C. difficile infection is by administering a powerful antibiotic. Unfortunately, the treatment often fails to eradicate the bacteria completely, resulting in recurrence.

Difficulties in Eradicating Recurrent Infection

Clearly, the present course of treatment needs improvement. Are patients suffering from C. difficile infection expected to undergo the antibiotic treatment every time they experience a recurrence? That will only trap them in a cycle of infection and treatment. Instead of depending on an imperfect antibiotic treatment, perhaps the answer to preventing recurrence exists in the novel and innovative field of biologic therapy.

Using biologic therapy to address a public health threat may seem extreme when large-molecule drugs are more often linked to treating autoimmune disorders, but the devastating effects of the infection may call for it. Studies say that more than 9% of C. difficile-related hospitalizations end in death, which is almost five times more than any other type of hospital stay. Factor in cases linked to nursing homes, clinics and doctors’ offices and the number rises to 500,000 a year. Actual deaths might even reach as high as 30,000 annually.1

The biggest irony is that the healthcare facilities where these infections take place could easily prevent the spread of infection. Unfortunately, they’ve been slow to adopt proven strategies. Simple actions such as washing hands between patient visits or properly disinfecting rooms and equipment would help stem the spread of the bacteria. Instead, the inability to implement preventative strategies leaves the most at-risk populations vulnerable—mostly especially the elderly, people with compromised immune systems, and patients recovering from surgery.

Until such facilities can observe best practices to stem the rate of C. difficile infection, a treatment will be necessary. Unfortunately, the present treatment has limitations aside from failure to prevent recurrence. The antibiotic involved wipes out beneficial gut bacteria in addition to the infection, leaving the patient with a whole slew of other complications. In fact, this is one of the main reasons for recurrence: the healthy bacteria fail to recover, allowing C. difficile to flourish. Some people have found a way to cope with this by taking a so-called fecal pill2, but it’s highly doubtful that such a controversial treatment would ever be FDA-approved. For a better, less repugnant course of treatment, biologic therapy could provide an answer that is better received.

Biologic Therapy Can Lessen the Threat Posed by C. difficile

Presently, biopharmaceutical companies are developing two forms of biologic therapy to address C. difficile infection. One involves an enzyme that can protect the microbiome.3 Because C. difficile thrives when beneficial bacteria is eradicated by antibiotic treatment, the idea is to protect the existing flora. By ensuring the survival of healthy “good” bacteria, the proliferation of the infection can be prevented while the patient undergoes treatment. The other approach is a monoclonal antibody that targets the toxin secreted by the bacterium and causes the associated infections.4 Like the protective enzyme, the monoclonal antibody would be used in conjunction with antibiotic treatment.

Regardless of biologic therapy development, the main cause of C. difficile infection is due to the inability to adhere to preventative strategies. Simple hygienic practices could curb the number of cases per year. Instead, this failure has resulted in the C. difficile becoming the number one public health threat.

Companies working on developing biologic therapy to treat C. difficile and other diseases need to ensure safety and quality. It must be prioritized during the research, development, and manufacturing process. This protects both the public and the company. For the public, their health and well-being is guaranteed. For the company, it prevents problems that could arise later down the road such as product recalls or loss in reputation.

BIOVIA Biologics is an innovative digital suite that supports the discovery and development of novel biologic therapies. Offering tools that can process high volume data, it has the ability to design and manage the screening assays required to ascertain the viability of potential candidates. To further test candidates, the solution also features a 3D modeling environment that allows users to predict and optimize physical properties. Contact us today to learn more.

  1. “Far more could be done to stop the deadly bacteria C. diff,” August 16, 2012, http://usatoday30.usatoday.com/news/health/story/2012-08-16/deadly-bacteria-hospital-infections/57079514/1
  2. “The Enema of Your Enemy is Your Friend,” January 17, 2013, http://slate.me/1mORJP5
  3. “Synthetic Biologics Highlights New Data from C. difficile Program Presented at the 54th ICAAC,” September 7, 2014, http://www.fiercebiotechresearch.com/press-releases/synthetic-biologics-highlights-new-data-c-difficile-program-presented-54th
  4. “UMMS monoclonal antibody to treat C. difficile shows promise in clinical trial,” September 20, 2015, http://www.umassmed.edu/news/news-archives/2015/09/umms-monoclonal-antibody-to-treat-c-difficile-shows-promise-in-clinical-trial/

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