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Head of Medical Affairs at Nestlé Health Science

At MAD-ID, Dianne Nguyen, MD, shares Phase 3 data showing consistent tolerability of the microbiome therapy across high-risk patient populations

Vowst Maintains Consistent Safety Profile in rCDI Patients With Comorbidities

Along with a 1 reported case in Massachusetts, the

New Hampshire Department of Health and Human Services (DHHS) has confirmed a person infected with eastern equine encephalitis (EEE) has died. The public health agency said the person was hospitalized due to severe central nervous system disease. The last reported human EEEV infection in New Hampshire was in 2014, when DHHS identified 3 human infections, including 2 fatalities. In the same statement, DHHS mentions there has been 1 confirmed case in Vermont this summer.

On August 16, the Massachusetts Department of Public Health (MDPH) released a statement discussing the confirmation of the first human case of EEE in the state this year. The confirmed case was discovered in an 80 year old man who was exposed to the vector borne disease in Worcester County. As a result, the risk level in the local communities of Douglas, Oxford, Sutton, and Webster has been raised to critical, and in Dudley, Northbridge, and Uxbridge the risk is increased to high.

Additionally, the neighboring communities of Auburn, Charlton, Grafton, Leicester, Mendon, Millbury, Millville, Southbridge, and Upton are now considered at moderate risk according to MDPH.

“This is the first time we have seen a person infected with EEE in Massachusetts since 2020,” Public Health Commissioner Robbie Goldstein, MD, PhD, said in a statement. “EEE is a rare but serious disease and a public health concern. We want to remind residents of the need to protect themselves from mosquito bites, especially in areas of the state where we are seeing EEE activity.

Though very rare, EEE is serious and a potentially fatal disease that can affect people of all ages. EEE is generally spread to humans through the bite of an infected mosquito. There were 12 human cases of EEE in Massachusetts in 2019 with 6 deaths, and 5 human cases with 1 death in 2020. There were no human cases of EEE in Massachusetts in 2021, 2022, or 2023.

EEE has a fatality rate of 33% to 70%, with most deaths occurring 2–10 days after the onset of symptoms.

In addition to a high mortality rate, long-term physical and mental complications, including permanent neurological deficits have been identified in many people who survive EEE.

Plymouth is approximately 40 miles south of Boston along the coast, and Worcester County is in the middle of the state, so the 2 areas are not in close proximity, but due to the elevated risk locally, the town of Plymouth decided to take action in response to outdoor parks. As of last Friday, all town public parks and fields are close daily from dusk until dawn.

“As Mass DPH has now elevated Plymouth’s EEE risk status to high, it is important to take extra precautions when outdoors and follow state and local health guidelines to avoid unnecessary risk to exposure to EEE. The health and safety of our community, residents, and visitors remain our priority,” Plymouth’s Commissioner of Health and Human Services, Michelle Bratti, said in a statement.

According to the Centers for Disease Control and Prevention (CDC) most people who are infected with the virus do not develop symptoms; however, for those that do, the date from the bite to the onset of the illness is 4 to 10 days. EEE can also result in fever or neurologic disease. The type of illness will depend on the age of the person and other factors. Those who are infected can develop meningitis.

There are no FDA-approved treatments for EEE and for patients who develop severe cases, they can be hospitalized to receive supportive treatment.

Over the weekend, MDPH detailed plans of spraying for mosquitos including aerially in areas of Plymouth County, and truck-mounted spraying in parts of Worcester County. As of Saturday, 10 communities in Massachusetts were raised to high or critical risk for EEE virus.

“The risk from EEE is high in parts of Plymouth County and critical in parts of Worcester County,” State Epidemiologist Catherine M. Brown, DVM, said in a statement. “In addition to recommending that people use mosquito repellent with an EPA-registered active ingredient and clothing to reduce exposed skin, we also recommend that evening outdoor events be rescheduled to avoid the hours between dusk and dawn. The mosquitoes most likely to spread EEE are most active during the dusk to dawn hours.”

There are preventative strategies to avoid EEE, and the MDPH has listed such measures 

For those who live in Massachusetts and want more information on EEE, it can be found 

 or by calling the DPH Division of Epidemiology at 617-983-6800.

1.NH DHHS Identifies Person Infected with Eastern Equine Encephalitis Virus in New Hampshire.The New Hampshire Department of Health and Human Services. August 27, 2024. Accessed August 28, 2024.
https://www.dhhs.nh.gov/news-and-media/nh-dhhs-identifies-person-infected-eastern-equine-encephalitis-virus-new-hampshire
2. State health officials announce season’s first human case of Eastern Equine Encephalitis in Massachusetts. MDPH. August 16, 2024. Accessed August 27, 2024.
https://www.mass.gov/news/state-health-officials-announce-seasons-first-human-case-of-eastern-equine-encephalitis-in-massachusetts
3.Plymouth to Close all Public Parks and Fields from Dusk to Dawn. Town of Plymouth. August 23, 2024. Accessed August 27, 2024. PDF.
4. Eastern Equine Encephalitis: Symptoms, Diagnosis, and Treatment. CDC. May 15, 2024. Accessed August 27, 2024.
https://www.cdc.gov/eastern-equine-encephalitis/symptoms-diagnosis-treatment/index.html
5. State officials announce plans to spray for mosquitoes in sections of Worcester and Plymouth counties due to EEE. MDPH. August 24, 2024. Accessed August 27, 2024. 
https://www.mass.gov/news/state-officials-announce-plans-to-spray-for-mosquitoes-in-sections-of-worcester-and-plymouth-counties-due-to-eee



The town of Plymouth decided to prohibit people from using the parks from dusk to dawn due to concerns over eastern equine encephalitis after a man contracted the rare disease in the state.

Concerns Over Mosquito-Borne Illness Causes Massachusetts Town to Create Curfew for Parks, Spraying in Counties

Merck (NYSE: MRK) announced today it is initiating two global Phase 3 clinical trials for MK-8527, its investigational once-monthly oral pill for HIV pre-exposure prophylaxis (PrEP). The announcement coincides with the presentation of Phase 2 data at IAS 2025, the 13th International AIDS Society Conference on HIV Science, held in Kigali, Rwanda.

Merck has announced the launch of 2 global phase 3 clinical trials for MK-8527, its once-monthly oral HIV preexposure prophylaxis (PrEP) candidate. The announcement coincides with new phase 2 data presented at IAS 2025, the 13th International AIDS Society Conference on HIV Science. Luisa M Stamm, MD, PhD, associate vice president of infectious disease clinical research and section head for HIV at Merck, said the candidate shows promise in addressing current prevention gaps.

“MK-8527 is a novel class of antiretrovirals,” Stamm explained. “It primarily inhibits viral replication through 2 unique mechanisms of action. Firstly, it incorporates into the reverse transcriptase and blocks RT translocation, preventing further incorporation of nucleotides into the nascent viral DNA. This results in immediate chain termination. Secondly, if translocation does occur, 8527 induces a structural change in the viral DNA that results in a delayed chain termination.”

Together, these actions contribute to MK-8527’s high potency and strong resistance barrier. The drug also has a long intracellular half-life, making it suitable for extended dosing. “The intracellular triphosphate—the active form of 8527—has a half-life of 10 days,” Stamm noted. “At the selected phase 3 dose of 11 mg, we are predicted to stay above the target efficacy concentration for a month.”

New Trials Aim to Address Gaps in Global PrEP Access

Merck’s 2 newly launched phase 3 studies—EXPrESSIVE-10 and EXPrESSIVE-11—will enroll more than 9000 participants collectively. EXPrESSIVE-10, conducted in partnership with the Gates Foundation, will enroll 4580 adolescent girls and women aged 16 to 30 years in Kenya, South Africa, and Uganda. EXPrESSIVE-11 will enroll 4390 participants across 16 countries beginning in August 2025.

“Our once-monthly PrEP candidate, MK-8527, has the potential to address critical gaps in HIV prevention, particularly for communities with limited access to daily options,” said Eliav Barr, chief medical officer at Merck Research Laboratories.

Stamm added that the trials were designed to reflect real-world use and prevention challenges. “When we were thinking about the EXPrESSIVE studies, we decided that daily FTC/TDF [emtricitabine/tenofovir disoproxil fumarate] was a reasonable comparator,” she said. “Globally, FTC/TDF is the most accessible standard of care currently, and we thought it was most valuable to do a comparison of oral daily vs oral monthly—so oral vs oral.”

Both studies will use adjudicated HIV infections as the primary end point and will integrate pharmacokinetic (PK)-based adherence assessments. “We acknowledge that with these regimens, efficacy is highly linked to adherence,” Stamm said. “These PK assessments will help us better understand how adherence impacts efficacy for both the daily and monthly regimens.”

To ensure representative and equitable enrollment, participants will be randomly assigned 1:1 and stratified based on key variables. “For EXPrESSIVE-10, we will be stratifying by age,” she said. “For EXPrESSIVE-11, we’ll stratify by geography and gender/gender identity.”

At IAS 2025, Merck shared data from a phase 2 double-blind trial (NCT06045507) in 350 adults with low-risk disease. Participants received MK-8527 at doses of 3, 6, or 12 mg or placebo monthly for 6 months. Results showed no clinically significant laboratory abnormalities—including in CD4 and lymphocyte counts—and a safety profile comparable to placebo. “The data we’re presenting at IAS 2025 support advancing into phase 3 trials,” said Barr.

Global Collaboration and Community Engagement

EXPrESSIVE-10 is being funded by the Gates Foundation through the International Clinical Research Center at the University of Washington and the University of Alabama at Birmingham. Community advisory groups will play a key role in guiding culturally sensitive outreach and participant engagement at 31 sites across sub-Saharan Africa.

“Only 18% of global PrEP demand is met,” said Trevor Mundel, president of global health at the Gates Foundation. “We need long-acting, scalable solutions like MK-8527 to close the prevention gap.”

Stamm emphasized the care taken to select trial locations where PrEP could make the greatest impact. “The team has worked on selecting countries and sites with populations that would most benefit from PrEP, with the highest likelihood of exposure to HIV,” she said.

Stay tuned for part 2, where Luisa Stamm will discuss the HIV prevention pipeline and provide closing thoughts on the program.

At IAS 2025, Luisa Stamm, MD, PhD, explains the NRTTI’s mechanism, study setup, and key data on HIV prevention efforts.

Conferences

Merck’s MK-8527 Advances to Phase 3 for Once-Monthly HIV Prevention

TAXIS Pharmaceuticals announced today that it has received a US Food and Drug Administration (FDA) qualified infectious disease product (QIDP) designation for TXA14007, its investigational efflux pump inhibitor (EPI), in combination with levofloxacin for the treatment of hospital-acquired pneumonia and ventilator-associated pneumonia.

The QIDP designation will allow the company to have access to the FDA's Fast Track program, allow for priority review, and make the compound eligible for a potential 5-year extension of market exclusivity upon approval. These advantages are designed to accelerate the development and review processes, ensuring that novel therapies can reach patients faster and address urgent public health needs efficiently. With the support of this designation, TAXIS Pharmaceuticals is poised to advance the development process for its EPIs.

"The QIDP designation is a critical milestone in our mission to deliver effective solutions against antimicrobial resistance," TAXIS Pharmaceuticals CEO Gregory Mario said in a statement. "Too many people are dying from infections like hospital-acquired pneumonia—infections that should be treatable. We are committed to our mission because we know that lives are on the line."

TAXIS is a clinical-stage company developing new classes of therapies to treat multidrug-resistant bacterial infections. Their investigational drug candidates include EPIs, dihydrofolate reductase inhibitors, and FtsZ inhibitors and aim to combat antimicrobial resistance.



A Group of Antimicrobial Compounds Shows Novelty Action Against Multidrug-Resistant Gonorrhea


The TXA14007 class of EPIs significantly enhanced the effectiveness of levofloxacin and other antibiotics against a wide range of drug-resistant 

strains found in clinical settings. Preclinical data on TXA14007 show no signs of inherent toxicity and find that it is effective in improving the action of levofloxacin in animal efficacy models.

This news marks the company’s second FDA QIDP designation. The first was granted for TXA709, the company's first investigational FtsZ inhibitor candidate, aimed at treating antibiotic-resistant methicillin-resistant 

(MRSA). TAXIS is seeking additional funding and partnerships with drug manufacturers to continue the development and commercialization of its investigational EPIs and its broader portfolio of investigational therapies aimed at addressing the escalating burden of antimicrobial resistance.



Reference
1. TAXIS Pharmaceuticals earns FDA QIDP designation for TXA14007, an investigational efflux pump inhibitor (EPI) to combat antibiotic-resistant pneumonia. Press release. TAXIS Pharmaceuticals. July 15, 2025. Accessed July 15, 2025. 
https://www.prweb.com/releases/taxis-pharmaceuticals-earns-fda-qidp-designation-for-txa14007-an-investigational-efflux-pump-inhibitor-epi-to-combat-antibiotic-resistant-pneumonia-302503970.html

The designation is for the company’s TXA14007, its investigational antibiotic to be studied in combination with levofloxacin. 

TAXIS Pharmaceuticals Earns FDA QIDP Designation for Its Efflux Pump Inhibitor for Pneumonia

 suggests that current communication strategies about antimicrobial use (AMU) in food-producing animals often fail to employ framing techniques that resonate with key stakeholders, particularly farmers and producers, potentially weakening support for critical 

 (AMR) measures. The study offers not only a novel framework for evaluating AMR policy language but also a call to reframe the narrative in ways that are grounded, inclusive, and actionable across disciplines and regions.

The study, led by Carly Ching, PhD, a research scientist at Boston University, analyzed policy documents issued by international organizations, including the Food and Agriculture Organization (FAO) and the World Organization for Animal Health (WOAH). Using a combination of inductive and deductive coding, the research team examined how the risks of AMR and rationales for reducing AMU in agriculture were framed across institutional texts.

The most frequently used motivational frame overall was “human health,” making up 20.9% of all frames identified. This was followed by “animal health and welfare” at 18.2% and “food production and security” at 14.5%. Notably, frames appealing to self-interest, those that might directly motivate behavior change among farmers or agricultural workers, were rarely present.

“Pushback from industry stakeholders continues to hinder progress on antimicrobial resistance policies in livestock,” Ching said in our email interview. “Framing and language choices are critical tools to build political legitimacy and end-user support.”

When asked how self-interest framing could be responsibly applied in public health communications, Ching explained, “Public health communicators can operationalize self-interest framing by emphasizing direct benefits to the target audience that align with scientific evidence. Sharing personal stories from other producers who have successfully reduced antimicrobial use can also help build trust and relevance. As such, cocreation with farmers, producers, veterinarians, and other stakeholders is important to improve resonance and accuracy. Importantly, farmers are also part of the wider community and thus act with overlapping agency, so connecting individual benefits to broader core public health outcomes can bolster messaging.”

The analysis also uncovered notable institutional differences in framing priorities. “We analyzed documents published by the Quadripartite Joint Secretariat on AMR. In reviewing documents from the FAO and WOAH, we found each organization focused on different priorities,” Ching said. “FAO emphasized ‘food production and security,’ while WOAH focused more on ‘animal health and welfare’ and rarely used the food-related frame. This makes sense to some degree, as it aligns with their respective missions.”

However, the team noted that a dominant use of one animal-related frame often came at the expense of others. “Across all documents, we noticed that when one of these animal-specific frames was used more, the other was used less. Interestingly, both organizations also frequently used the collective ‘human health’ frame more than a second animal-specific one. This suggests a tendency to focus on one main animal-related reason for addressing antimicrobial resistance rather than balancing multiple motivations.”

Ching also discussed the importance of cultural and sector-specific messaging. “In terms of sector or culturally tailored messaging, while human and animal health are connected in a One Health approach, the expectations are often different,” she noted. “In agriculture and farming, there is a push to be voluntarily better than standard practices, while in human health care, clinical guidelines pertaining to antimicrobial use are standard. Therefore, calling normal farm practices ‘misuse’ can confuse or upset farmers, since these are common in their context. Farming norms can also vary by country. To build trust and cooperation, it’s important to use inclusive, nonblaming language that respects different practices and avoids implying one region has superior practices.”

The study concludes with practical recommendations aimed at refining AMR policy communication strategies: increasing the use of self-interest frames, making messaging more accessible, and explicitly addressing underlying assumptions that may not align with agricultural realities.

When asked how these findings could shape future AMR action plans under the One Health framework, Ching emphasized, “From our findings, we recommend creating messages that are more personally relevant to the end-user, using clear language, and choosing frames that support global interests and cooperation. Although our focus was on reducing indiscriminate antibiotic use in food-producing animals, we found that One Health messaging still leans heavily toward human health, with less attention to the other sectors, including the environment. Thus, a conscious effort still needs to be made to present and uphold an integrated perspective of all One Health domains. Finally, these recommendations should be adapted to local contexts with input from key stakeholder groups, including end-users.”

Reference
Ching C, Zaman MH, Wirtz VJ. Policy discourse on AMR in food-producing animals: examining framing and language for effective communication. 

Analysis by Carly Ching, PhD, reveals that global AMR policies overemphasize human health while neglecting farmer-focused messaging that could improve adoption and impact.

Study Results Find AMR Policy Messaging Misses the Mark With Agricultural Stakeholders

On June 17, 2025, the US Food and Drug Administration approved a new prefilled syringe presentation of recombinant zoster vaccine, adjuvanted (Shingrix) developed by GSK for the prevention of shingles (herpes zoster). The approval follows a regulatory review of data demonstrating the comparability of the prefilled syringe with the current reconstituted format.

The new format removes the need for health care providers to manually reconstitute the vaccine before administration, offering a more convenient delivery method. The vaccine’s composition, glycoprotein E antigen combined with the AS01B adjuvant system, remains unchanged.

Since its initial US approval in 2017, more than 90 million doses of zoster vaccine have been distributed across the country. It is indicated for use in adults 50 years or older as well as adults at increased risk due to immunodeficiency or immunosuppression.

Shingles, caused by the reactivation of varicella-zoster virus (VZV), affects approximately 1 million Americans annually. By age 50, most adults carry latent VZV, and age-related immune decline increases the risk of developing shingles.

Shingles is a painful rash illness caused by reactivation of the VZV—the same virus responsible for chickenpox. It typically begins with tingling, pain, or itching, followed by a blistering rash on one side of the body or face that heals in 2 to 4 weeks. Although most recover fully, the most common complication is postherpetic neuralgia, a severe, long-lasting nerve pain that affects 10% to 18% of patients with shingles, especially older adults. Other rare but serious complications include vision loss, bacterial infections, pneumonia, encephalitis, and even death. Vaccination is recommended to reduce risk and severity.

The new presentation supports broader access and ease of administration, aligning with GSK’s strategy to optimize delivery of preventive vaccines in aging and immunocompromised populations.

1. US FDA approves GSK’s SHINGRIX in a prefilled syringe presentation. News release. GSK plc. July 17, 2025. Accessed July 17, 2025. https://www.businesswire.com/news/home/20250717301201/en/US-FDA-Approves-GSKs-SHINGRIX-in-a-Prefilled-Syringe-Presentation

2. Shingles (herpes zoster). Centers for Disease Control and Prevention. Accessed July 17, 2025. https://www.cdc.gov/shingles/index.html


New format eliminates reconstitution step, offering greater convenience for providers and supporting expanded access for at-risk adults.

FDA Approves Prefilled Syringe Presentation of GSK’s Shingrix for Shingles Prevention

Lead author Elizabeth Marlowe, PhD, D (ABMM), offers insights on her study looking at this ongoing issue including which states have the largest number of hepatitis D infections, the potential  implications for increased testing and the linkage to clinical care in a more efficient manner.  

Screening Study For Hepatitis B Shows Nearly One Third Also has Hepatitis D

Results from the first US study that looked at hepatitis B virus (HBV) and hepatitis D virus (HDV) prevalence concurrently found that 2.2% of HB surface antigen (HBsAg)

positive specimens were positive for HDV antibodies (Abs), and of those, 28%, or approximately one-third, were positive for HDV RNA or active infection.

The study’s results were published in the 

“We looked at over 5200 specimens across the US. About 2.2% of those were positive for hepatitis D antibodies,” said study first author Elizabeth Marlowe, PhD, D(ABMM), executive scientific director of infectious diseases for Quest Diagnostics. “Now the algorithm is if the antibody is positive, you then want to run a PCR [polymerase chain reaction] to look for RNA, which means you have active infection. And of those, about 28% of those were positive for RNA.”

The study investigators looked at deidentified remnant HBsAg-positive specimens submitted for routine clinical testing to Quest, representing all 10 US Department of Health and Human Services (HHS) regions. Female participants made up 45% of the participants, and the mean ages were 50.8 (male) and 49.4 (female) years. Reflex testing of HBsAg-positive specimens for HDV antibody testing and further testing of positive specimens for HDV RNA were conducted from July 2023 to June 2024.

As the study looked at prevalence by HHS region, one interesting finding was the highest absolute number of HDV Ab-positive specimens in HHS Region 9, which includes California, Nevada, and Arizona.

HDV is concerning because of its ability to progress to more serious complications, including cirrhosis and hepatocellular carcinoma. Wranke et al showed that having HDV leads to a faster progression to the aforementioned conditions and other liver-related end points.

“Given the serious nature of the disease, universal testing of HBsAg-positive specimens followed by reflex HDV RNA would increase our understanding of HDV prevalence, allow for earlier identification and linkage to care, and benefit patients with previously unrecognized HDV infection,” the 

Marlowe mentioned updated screening guidelines that are expected to come out soon and why HDV testing should be considered in testing for HBV. She referenced Robert Gish, MD, who is the medical director of the Hepatitis B Foundation and a fellow study author. 

“He'll always tell you, if you have a patient [with] hepatitis B surface antigen–positive [results], always screen for hepatitis D,” Marlowe said.

Traditionally, screening and receiving treatment for hepatitis can take 2 to 3 provider visits. However, there is a newer concept within hepatitis C care called “test and treat,” which looks to streamline the care process and may be applicable to patients with undetected chronic HBV and HDV. The concept simply has patients getting tested for the virus and leaving with medicine or a prescription for treatment all in the same appointment. The significance here is getting more people into the continuum of care.

“I think it's an exciting area," Marlowe said of test and treat. "I think it goes back to implementation science…and we want to improve screening rates, so if you have a patient in the office, you can screen them, and you're not going to lose them to follow-up—that's the goal, right?”


References
1. Marlowe EM, Swanson BE, Realegeno SE, Meyer WA 3rd, Gish R, Kagan RM. Epidemiological burden of hepatitis delta virus in the United States. 

. 2025;32(6):e70029. doi:10.1111/jvh.70029
2. Wranke A, Heidrich B, Deterding K, et al. Clinical long-term outcome of hepatitis D compared to hepatitis B monoinfection. 

. 2023;17(6):1359-1367. doi:10.1007/s12072-023-10575-0



In our latest podcast, first author Elizabeth Marlowe, PhD, D(ABMM), offers insights on her study looking at this ongoing issue, including the need for increased testing and getting patients into the continuum of care in a more efficient manner.  

Dianne Nguyen, MD

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