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1rem

“Usually for antibiotic awareness you have a week,” said Dr. Teena Chopra, “But for 

a whole month has been dedicated, for a reason.”

Awareness Month and Antimicrobial Awareness Week. As Chopra explains, too often the people most affected by a lack of vigilance in these areas already experience marginalization and discrimination.

“We are all global citizens, and having that uniform, consistent health care for all is where we need to move toward,” said Chopra.

Teena Chopra, MD, MPH is the Corporate Medical Director of Hospital Epidemiology at Detroit Medical Center, as well as a professor at the Wayne State University School of Medicine.

Chopra credits several mentors as inspiring her to specialize in infectious disease. Living and working in Detroit, MI, she has seen firsthand how infectious diseases can ravage underserved populations, moving her to practice where she’s most needed.

causes an estimated half a million infections a year and over a billion dollars in expenses in the US alone.

The Centers for Disease Control and Prevention (CDC) classifies 

However, until the disease touches their lives, the general public is largely unaware of its prevalence or even what 

 is. “We, as the health care community, need to raise more awareness for 

Listen in as Chopra discusses treatment regimens for 

 infection (CDI), as well as the populations disproportionately affected by this debilitating disease.

Missed Episode 6 of Contagion Community? 

Listen in on the conversation and feel free to offer your feedback on this episode, interest in participating in the podcast, or suggest ideas for future episodes. Please email your correspondence to Nina Cosdon: 

Dr. Teena Chopra discusses the global need to do more to prevent healthcare-associated infections like C difficile in vulnerable patient populations.

C difficile, Antimicrobials, and the Patients Most Affected

Environmental contamination plays a larger role than previously recognized, prompting calls for updated infection control strategies

New Genomic Study Reveals Hidden Pathways of C difficile Transmission in Hospitals

Lumen Bioscience’s, LMN-201, was considered safe and well-tolerated and there were no severe dose-related or serious adverse events reported.

Investigational Oral Biologic Achieves 100% C difficile Clinical Cure in Preliminary Cohort

Fecal microbiota transplantation emerges as the top treatment, while probiotics show limited effectiveness in preventing CDI recurrence.


New Meta-Analysis Highlights Most Effective Treatments for Clostridioides difficile Infection

Nature Medicine published additional data on Vedanta Biosciences’ Clostridioides difficile investigational therapy, VE303, from its phase 2 trial.

Investigational Live Biotherapeutic Product Significantly Reduces Risk of Recurrent Clostridioides difficile 

CEO Larry D Sutton, MD, PhD, elaborates on the company's strategy and the science behind SIDIPREV to prevent C difficile infections in hospitalized patients.

LPOXY Therapeutics Acquires Assets to Advance C difficile Protection for Antibiotic Patients

The Peggy Lillis Foundation (PLF) will host its annual summit and lobby day in Washington at the end of this month

Advocacy and Education in DC: C Diff Summit and Lobby Day 

The Peggy Lillis Foundation is hosting its annual National 

 Summit, which is going to be held on Monday, March 31, at the Kellogg Conference Hotel at Gallaudet University in Washington DC. The annual event brings together clinicians, industry, 

 patients, caregivers and other stakeholders. This year’s Summit will feature scientific updates in the morning, networking for all attendees over lunch, and hands-on training for volunteers in the afternoon.

Volunteers will receive training on lobbying and testifying to regulatory bodies, speaking to the media and presenting at conferences, providing emotional and logistical support to 

 patients and family members, and serving as patient advisors on clinical trials, among other topics.

PLF’s CEO Christian John Lillis says the summit is returning to its roots and taking a back-to-basics approach, where they put the emphasis on people with the condition and growing their advocacy. 

“The past couple of years, coming out of COVID, the summit has tended to be more science heavy, but this year we're back to basics,” Lillis said. “We are really focused on recruiting new volunteers, and getting new people into the movement.”


The summit’s scientific presentations will include:

 Patient Experience - Alla Paskovaty, PharmD, Nestle Health Science

 Dilemma: How Hospital Policies and Environmental Contamination Keep Infections Alive - Bobby Warren, MPS, Duke Center for Antimicrobial Stewardship and Infection Prevention

Rapid Diagnostics Role in Helping to Prevent 

Developing a First-in-class Live Biotherapeutic Product to Prevent Recurrent 

 Infection - Quinn Dinh, MD, Vedanta Biosciences

The afternoon volunteer education sessions will include:

Patient Education - Bruce Hirsch, MD; Mollie Lauck, MSN, CRNP, PHRN

Public Speaking - Christian John Lillis, CEO of Peggy Lillis Foundation

Peer Support - Kee Kee Buckley, Pam McCollister, Jamie Webb

Regulatory Advocacy - Tim Clark, Ferring Pharmaceuticals, Kevin Brennan, Bluebird Strategies

The next day, interested advocates can be part of an experience where they go up to Capitol Hill and lobby members of congress about 

 “Despite being in the fifth year of COVID, we still fail to take infectious disease seriously…I think it's important for Congress to hear from people who have lost a loved one to a disease like 

He says the advocates will meet with Senate and House legislators from California, Connecticut, Kentucky, Massachusetts, New Jersey, New York, Oregon, Pennsylvania, Texas, Utah, and Washington. They will speak to them about preserving and reserving the cuts to critical federal public health agencies, including HHS, CDC, FDA, NIH, and others.

Lillis says they will be focusing on the following:

Reintroduction and passage of the Safe Step and HELP Copays Acts

The importance of maintaining or increasing funding for federal public health in the FY2026 budget

The potential negative impact of tariffs on the cost of diagnostics manufactured in Canada and Mexico, which may lead to a decline in CDI diagnoses and antibiotic stewardship

For anyone interested in attending this free conference, individuals can register for it 

The Peggy Lillis Foundation's (PLF) CEO and Cofounder Christian John Lillis talks about these important events happening in the capital at the end of this month. 

Education and Advocacy in DC: The PLF C Diff Summit and Lobby Day 

Larry Sutton, MD, PhD, explained how oxygen can inhibit C difficile growth and support gut healing, paving the way for innovative treatments in inflammatory bowel diseases.

Targeting C difficile with Oxygen-Based Therapy

LPOXY Therapeutics, Inc has acquired key assets from Xeno Biosciences Inc to advance its therapy, SIDIPREV, aimed at preventing 

) infections in hospitalized patients. The acquisition includes regulatory filings, FDA correspondence, CMC data, intellectual property, and Phase I and Ib clinical trial data confirming the safety of the active pharmaceutical ingredient. This acquisition enables LPOXY to initiate a Phase II study of SIDIPREV under the FDA’s Limited Population Pathway for Antibacterial and Antifungal Development (LPAD).

In our recent conversation with Larry Sutton, MD, PhD, CEO of LPOXY Therapeutics, he discussed the significant impact of 

 infections, which cause over 30,000 deaths annually in the US, Sutton explained, 

C difficile is an anaerobic pathogen… it doesn't like oxygen, they can't detoxify oxygen, and they get sick from it.

 particularly susceptible to oxygen, which has been shown to inhibit its growth and suppress the production of toxins that cause disease. As Sutton elaborated, 

What oxygen does is it inhibits its growth and suppresses toxins production that causes disease.

In addition to its antibacterial effects, oxygen has been demonstrated to have anti-inflammatory properties, which could be beneficial for healing the gut and preventing infections. Sutton further noted, “Oxygen is an anti-inflammatory in the gut. So it can help the healing in that way as well.” This antimicrobial and anti-inflammatory dual effect supports the potential for oxygen-based therapies in treating gastrointestinal conditions.

One of the challenges with current oxygen delivery methods, such as hyperbaric oxygen therapy, is that they are cumbersome and not suitable for widespread use. Sutton pointed out, “All these other data that are out there in the academic literature administer oxygen through cumbersome and uncomfortable methods… however, an oral administration will.” Oral oxygen administration could provide a more practical and scalable solution, especially for patients with inflammatory bowel diseases like ulcerative colitis, for which current treatments are limited.

Looking ahead, LPOXY is focused on exploring oral oxygen delivery as a promising approach for preventing 

 infections and treating various inflammatory bowel diseases. Sutton highlighted, “There is a lot of data out there that oxygen is beneficial in inflammatory bowel disease, especially ulcerative colitis.” This emerging therapy could help address significant unmet needs in treating these challenging conditions.

LPOXY Therapeutics, Inc. Acquires Key Assets from Xeno Biosciences Inc. to Advance C difficile Prevention Therapy. January 4, 2024. Accessed January 13, 2024. 

https://firstwordpharma.com/story/5925021

Larry Sutton, MD, PhD, discussed how oxygen affects C. difficile and provides anti-inflammatory effects in the gut, with potential applications for gastrointestinal diseases.

Joseph Zackular, PhD suggests that mRNA vaccines and monoclonal antibodies could offer more effective treatments for recurrent C difficile infections

Targeting the C Diff Pathogen and Its Immune-Suppressing Toxins

In the next part of our conversation with Joseph Zackular, PhD the discussion centered on 

 infections, the impact of antibiotics on the microbiome, and emerging approaches to treatment, including vaccines and monoclonal antibodies. One of the key takeaways is the potential of vaccination to prevent severe disease, even in recurrent infections, by overcoming the immune-suppressing effects of 

As Zackular explains, antibiotics, which are the primary treatment for 

, also disrupt the very microbiome that normally protects against the pathogen. This creates a paradox where the treatment itself increases susceptibility to infection:

“When we think about recurrent and relapsing infections, that’s a big problem with 

 is perturbation of your normal, healthy microbiome, which normally confers resistance to this pathogen. The main risk factor is antibiotics. So when you perturb this community, it becomes susceptible to 

. But there’s this paradox where the way we treat 

 is antibiotics, which is the thing that makes you susceptible to 

.” This paradox creates a cycle where patients suffering from recurrent 

infections are caught in a loop of antibiotic use, gut microbiome disruption, and persistent vulnerability to the infection.

 is so difficult to treat lies in the way the bacteria’s toxins interact with the immune system. When a person becomes infected, 

 releases toxins that damage the gut lining, leading to the characteristic symptoms of the infection, diarrhea, fever, and abdominal pain. These toxins also have a more insidious effect: they suppress the body’s adaptive immune response, making it harder for the immune system to respond effectively.

, the toxins actually stunt adaptive immune responses to themselves,” said Zackular. “The toxins don’t just go after the barrier itself but can translocate and impact immune cells that are critical for responding to the infection.”

This suppression of the immune system is one reason why 

 infections tend to recur in certain patients. Their immune systems are effectively “hobbled” by the very toxins produced by the bacteria, preventing a full immune response. Zackular’s research has shown that a targeted vaccine could help reverse this immune suppression, potentially preventing recurrence.

“We were able to show that if you vaccinate after infection, you can overcome that stunting of the toxins on the immune system. This is important because people who suffer from recurrent infections aren’t getting help from their immune system. By vaccinating after the initial infection, we might be able to repair that stunted immune response and give the gut’s microbiome some help from the immune system.”

Historical vaccine attempts failed because they targeted only the toxins rather than the pathogen itself. mRNA vaccines offer a promising solution, addressing toxins and the pathogen while also providing flexibility to adapt to emerging strains. 

“There have been several vaccines that showed early promise but ultimately failed in phase three clinical trials. These vaccines targeted the toxins 

 produces two potent toxins that drive the disease. But just targeting the toxins and providing immunity to them might not be enough,” explained Zackular. “We found that focusing only on the toxins with protein-based vaccines didn’t provide the protection we had hoped.”

The emergence of mRNA vaccine technology, which has shown success in combating other infectious diseases like COVID-19, provides new hope for 

 treatment. Unlike traditional protein-based vaccines, mRNA vaccines can be designed to target both the toxins and the pathogen itself. Additionally, mRNA platforms are highly adaptable, making them capable of addressing new and emerging strains of 

“The mRNA vaccine platform has real potential,” said Zackular. “We can target the toxins like previous vaccines did, but we can also make it multivalent and target other aspects of this complex system. This could help overcome some of the limitations of the initial vaccines.” This multivalent approach allows for broader protection and may offer a more effective way to address the complexities of 

While monoclonal antibodies are valuable tools, Zackular emphasized the need for a combined approach, one that includes both vaccines and antibody treatments to effectively combat the infection.

“An FDA-approved monoclonal antibody called bezlotoxumab from Merck can be given to patients and has shown to be relatively effective. We know there is promise here, but we still need to develop the right vaccine platform with high immunogenicity, like potent mRNA vaccines, to address the complexity of the infection and the emergence of new strains,” he noted.

 strains is an ongoing challenge. New strains are emerging, not only in healthcare settings but also in the community, further complicating treatment. Zackular believes that mRNA vaccines offer the flexibility needed to adapt to this evolving landscape.

“We’re starting to see all different types of strains of 

 circulating across the globe, as well as the emergence of community-associated 

 infections, which are driven by a variety of 

 strains. The flexibility of mRNA vaccines gives us hope that we can adjust vaccines quickly for what we’re seeing in patients.” This adaptability could be important for staying ahead of new strains and ensuring that treatments remain effective over time.

Tune in for part 3 of our interview tomorrow on how hospital-acquired infections have decreased, community-acquired cases have risen, complicating targeting for prophylactic vaccination, and more.

Joseph Zackular, PhD suggests that mRNA vaccines and monoclonal antibodies could offer more effective treatments for recurrent C difficile infections


Joseph Zackular, PhD, shares insights on his team’s mRNA vaccine research for C. difficile, highlighting progress in animal models and future plans for human trials.

mRNA Vaccine Shows Potential for C difficile Infections

Joseph Zackular, PhD, an assistant professor at the Children's Hospital of Philadelphia and the University of Pennsylvania, is leading research on 

) and the development of an mRNA vaccine. His recent work has shown promise in reducing mortality and improving outcomes for infections caused by this bacterium.

In our recent interview, Zackular discussed how his team used animal models, including mice and non-human primates, to test the vaccine's safety, immunogenicity, and efficacy. 

 has long posed a major public health threat due to its ability to form spores that survive harsh environments, making treatment difficult. Zackular believes the mRNA vaccine could help address this persistent infection, especially for patients with recurrent cases.

The current study builds on promising results from animal models, including mice, where the vaccine showed encouraging efficacy. When asked about the transition from animal to human trials, Zackular emphasized the importance of animal models in understanding immune response, vaccine efficacy, and safety.

“To start with, animal models that recapitulate what we see in humans, so that we can study the immune response, the efficacy of, you know, treatments like vaccines, you know. So ultimately, thinking about safety, thinking about immunogenicity, thinking about the effectiveness of these strategies for taking on a challenging infection like 

," Zackular explained. He further noted that while animal models are valuable, the ultimate goal is to bring these therapies, particularly vaccines, to human trials.

"Our work in animal models was by design using physiologically relevant concentrations of these mRNA vaccines that would be safe for humans, validated by the work done with the COVID-19 vaccines. What we’re working towards now is using other animal models, like hamsters and non-human primates, to assess immunogenicity and safety, and ultimately bring this to phase one clinical trials to evaluate efficacy and safety in humans,” he said.

Zackular is hopeful that results from animal models will be replicated in humans, providing an important tool for addressing 

 is known for its ability to oscillate between a vegetative cell state and a dormant spore form, making it extremely difficult to eliminate. The pathogen's lifecycle, which includes toxin production and spore formation, complicates treatment and prevention efforts.

 is a really challenging and uniquely challenging pathogen for us to take on. It lives a really complex life cycle, and so, 

Joseph Zackular, PhD, shares insights on his team’s mRNA vaccine research for C difficile, highlighting progress in animal models and future plans for human trials.

C. Difficile

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