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By stopping unnecessary antibiotics before they start, clinicians can avoid unnecessary harm to the patient and the population. 

"Antibiotic Never Events": The Ideal Target to Reduce Antimicrobial Exposure

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

The FDA has approved Brexafemme (ibrexafungerp) for treatment of vulvovaginal candidiasis (VVC). The therapy was developed by Jersey City, NJ-based Scynexis.

The therapy, which represents the first approved drug in a novel antifungal class in more than 20 years, was approved based on positive results from 2 phase 3 studies in which oral ibrexafungerp demonstrated efficacy and a favorable tolerability profile in women with VVC.

“The FDA approval of Brexafemme is the culmination of years of work and a significant milestone for Scynexis, marking our evolution to a commercial-stage antifungal company. We are pleased with the approved label, highlighting the unique attributes of Brexafemme, and thrilled to be able to offer a new treatment option to women with vaginal yeast infections,” Scynexis CEO Marco Taglietti, MD, said. “We believe ibrexafungerp has significant commercial potential. This first approval in the US is a major step towards building the ibrexafungerp antifungal franchise as we intend to leverage an extended 10-year period of regulatory exclusivity and 14 years of patent protection.”

 from their phase 3 VANISH program, which had its VANISH 306 AND VANISH 303 studies, showed ibrexafungerp met its endpoints and achieved statistically significant superiority vs. placebo. In its VANISH 306 study, 188 participants were in the treatment arm and 84 were placed in the placebo group. In its VANISH 303 study, 188 participants were in the treatment arm and 98 were placed in the placebo group.

The company is also studying ibrexafungerp in its CARES study program for life-threatening fungal infections such as Candida auris in hospitalized patients.

“We are in a strong financial position to execute on our commercial plans and are committed to advancing our hospital programs to maximize the broad potential of this novel therapeutic class to help patients with serious and often resistant fungal infections,” Taglietti said.

Scynexis has partnered with Amplity Health to support the US commercialization of ibrexafungerp with a potential launch scheduled in the second half of this year.

This is the first oral non-azole treatment for vaginal yeast infections.

FDA Approves Ibrexafungerp

Matthew Hepburn, MD, executive vice president of Research and Development at Panther Life Sciences, discusses the technology and its potential usage.

Panther's Microarray Patch Offers Novel Therapy Delivery System for Potential Infectious Disease Applications

In a previous life, Matthew Hepburn, MD, an infectious disease physician,  worked with the Biden and Trump Administrations, and held the role of vaccine development lead for Operation Warp Speed, which was instrumental in developing COVID-19 vaccines in less than a year. This task was monumental considering it typically takes years to develop vaccines, and the pandemic was causing such a large human toll. 

Prior to that position, he has had a variety of roles in the Army and government including his 6-year tenure as a program manager at DARPA. Prior to joining DARPA, Hepburn served as the director of Medical Preparedness on the White House National Security Staff. His service in the Army included deployments to Iraq as a hospital Chief Medical Officer and numerous international engagements in establishing public health and clinical research partnerships.

With a long track record in government service, he recently transitioned to the private sector. In his current role as executive vice president of Research and Development at Panther Life Sciences, he will drive the company’s efforts to commercialize its patented Microarray Patch (MAP) technology, with a primary focus on reducing time-to-market and delivering the first commercial product to customers within the next 2 years. Panther is a start-up life sciences company based in New York City. 

“I have a massive newfound respect for people that are part of the startup community, because it is so challenging to be successful. It is such a commitment,” Hepburn said. “What I love about it is it reminds me a lot of that commitment we had at Operation Warp Speed, where everybody on your team is committed to the goal of making a big vision real.”

The patch platform is a novel technology which incorporates transdermal drug delivery systems. This consists of an array of tiny needles—each just hundreds of microns long—designed to pierce the outermost layer of the skin without reaching the deeper pain receptors, resulting in a virtually pain-free experience. Upon application, the biocompatible tips, which are loaded with therapeutic agents or vaccines, begin to dissolve within the interstitial fluid of the skin, releasing the medication directly into the epidermis and dermis.

“Micro needles are much shorter than the needle you get with a shot, but they go into your skin at the level where you can get a really effective immune response or use it to treat something,” Hepburn said. “So this idea of precision medicine—putting the right amount of material at the right time for the right patient—you can achieve a magnificent effect. And the design of these needles are such that you can put the vaccine or the drug on them. You surround them with these micro needles that are formed of polymers that just dissolve right underneath your skin. And they stay stable at room temperature."

He says this last part about the patch being able to deliver treatments or vaccines at room temperature as opposed to very cold freezer temperatures is an attractive component, and is a lesson they learned from COVID-19. 

"We know that with the COVID vaccines, as example, we had an amazing logistics team with the army and with the CDC to get the COVID vaccines out to people, but because the vaccines had to be kept at really, really cold temperatures, the logistical challenges were absolutely massive, and our team did our best to overcome those," Hepburn said. "But what we saw, especially for worldwide distribution, that sometimes maintaining those vaccines at that very cold temperature was essentially impossible to do so that access for people to receive their COVID vaccines—that was the biggest limitation. And it's a big limitation for lots of other vaccines and for therapeutic products as well." 

Although the technology is in its earliest stages, Hepburn does see it being utilized for infectious disease. He says right now they are working on the proof of concept first before they can pivot to specific disease states and applications.

This is part 1 of a 2-part interview. In the second installment, Hepburn will offer some insights on his time working on Operation Warp Speed. 

Reference
1.Operation Warp Speed Leader Tapped as Panther Life Sciences’ New R&D Chief. EIN Presswire. March 24, 2025. Accessed April 18, 2025.
https://www.einpresswire.com/article/796443993/operation-warp-speed-leader-tapped-as-panther-life-sciences-new-r-d-chief

From Pathogen to Infectious Disease Diagnosis: Test Determines Between Bacterial and Viral Infections in 15 Minutes

MeMed CEO Eran Eden, PhD, discusses the MeMed BV test, a rapid diagnostic tool that distinguishes between bacterial and viral infections in just 15 minutes, aiding clinical decision-making and antibiotic stewardship. The blood test, which analyzes three host-response proteins and generates a score to assess bacterial infection likelihood, has received FDA 510(k) clearance and the European CE Mark. Clinical studies showed a 63% reduction in unnecessary antibiotic use, accurate identification of previously missed bacterial infections, and better performance than traditional biomarkers like procalcitonin. Eden highlights the test’s ability to address diagnostic gaps, such as inaccessible infections, pathogen colonization, and superinfections, and reduce uncertainty that often leads to antibiotic misuse. By improving diagnostic accuracy, the MeMed BV test contributes to safer patient care and helps combat antimicrobial resistance.

CDC ACIP Meeting Examines Next Steps for Meningococcal, RSV, and Chikungunya Vaccination

At its April 16, 2025, meeting, the CDC’s Advisory Committee on Immunization Practices (ACIP) issued updated guidance on meningococcal, RSV, and chikungunya vaccines. ACIP supported using GSK’s MenABCWY pentavalent vaccine when both MenACWY and MenB are indicated, while also reviewing safety concerns with Sanofi’s MenQuadfi in infants. For RSV, ACIP recommended vaccinating at-risk adults aged 50–59, with further guidance pending on risk criteria and potential expansion to younger adults. Regarding chikungunya, ACIP endorsed the virus-like particle vaccine for travelers aged 12+ and lab workers with exposure risk, and the live attenuated vaccine for younger travelers, while noting rare but serious adverse events under investigation.

Disrupting HBV Chromatin Structure Blocks X Gene Transcription and Infection

A recent study led by Yael David, PhD, at Memorial Sloan Kettering Cancer Center uncovers how nucleosome positioning on hepatitis B virus (HBV) cccDNA directly controls transcription of the X gene, a key step in establishing infection. The research demonstrates that the chromatin-destabilizing compound CBL137 selectively disrupts HBV chromatin structure, reducing X gene transcription and blocking infection in primary human hepatocytes. These findings highlight a novel antiviral strategy that targets the epigenetic regulation of cccDNA, marking a shift from traditional replication-inhibiting therapies toward approaches that silence the viral reservoir itself, offering new potential in the pursuit of a functional cure for chronic hepatitis B.

Follow the Science: Why CD4 Testing is Critical in the Fight Against HIV/AIDS

Andreas Boehmler, PhD, emphasizes that expanding access to CD4 testing is essential for meeting global HIV/AIDS targets, particularly the UNAIDS 95-95-95 goal. Despite advances in HIV care, millions remain undiagnosed or untreated, and only 51% of countries incorporate CD4 testing in screening protocols for patients reentering care. CD4 testing, which tracks immune cell levels and signals disease progression, is vital for identifying advanced HIV, detecting treatment failure, and guiding care. Technological advancements have streamlined the once-complex process, making testing faster and more accessible. However, achieving widespread implementation requires strong infrastructure, trained personnel, reliable reagent delivery, and public-private partnerships. Boehmler calls for increased investment and international cooperation to sustain testing efforts and ultimately combat the HIV/AIDS epidemic.

Longhorn Advances a Scalable Universal Flu Vaccine

Longhorn Vaccines and Diagnostics has developed a novel universal influenza vaccine, LHNVD-110, designed to protect against human, avian, and swine flu strains, including pandemic variants like H5N1. Presented at ESCMID 2025, the single-composite peptide vaccine uses conserved epitopes from multiple influenza proteins and an ALFQ adjuvant to generate strong, durable immune responses in preclinical models with no observed reactogenicity. Jeff Fischer, MBA, president of Longhorn, emphasized the vaccine’s scalability, year-round manufacturing potential, and advantages over current seasonal flu vaccines. Positioned as a key tool in pandemic preparedness and aligned with a One Health approach, the vaccine and its monoclonal antibody cocktail are expected to enter IND-enabling studies in late 2025, with human trials to follow.

This week, the CDC ACIP's endorsement of meningococcal, RSV, and chikungunya vaccines, the need to expand automated CD4 testing for improved HIV/AIDS care, and more.

Conferences

Over 3 Million Children Died From AMR-Linked Infections in 2022

Gepotidacin, which was FDA approved last month for uncomplicated urinary tract infections, was found to be efficacious against gonorrhea even slightly exceeding the standard treatment for the sexually transmitted infection (STI). The study’s results were published in 

“Results of the primary analysis of microbiological response at test-of-cure demonstrated microbiological success rates of 92.6% (187 of 202 [95% CI 88·0 to 95·8]) in the gepotidacin group and 91.2% (186 of 204 [86·4 to 94·7]) in the ceftriaxone plus azithromycin group (adjusted treatment difference –0·1% [95% CI –5·6 to 5·5]),” The authors wrote. 

In terms of safety, the gepotidacin group did see higher rates of adverse events compared to the other group, mainly gastrointestinal events. The authors write that almost all were mild or moderate. No treatment-related severe or serious adverse events occurred in either group.

This study labeled as EAGLE-1, was a phase 3 open-label noninferiority trial examining oral gepotidacin compared with ceftriaxone plus azithromycin. The former was taken as 2 3,000 mg doses administered 10–12 hours apart, and the latter treatment was 500 mg intramuscular ceftriaxone plus 1 g oral azithromycin.

Participants had to have a bodyweight over 45 kg, and had suspected uncomplicated urogenital gonorrhea (including mucopurulent discharge), a positive laboratory test for 

, or both. Patients were randomly allocated in a 1:1 ratio to each treatment group, stratified by sex and sexual orientation.

The primary efficacy endpoint was defined as eradication of gonorrhea at test-of-cure (days 4–8). The noninferiority margin was prespecified at –10%. The primary outcome was assessed in the microbiological intention-to-treat (micro-ITT) population, all participants randomly allocated to a study treatment who received at least 1 dose of their treatment and had confirmed ceftriaxone-susceptible 

 isolated from the baseline culture of their urogenital specimen, the authors explained.

“Gepotidacin demonstrated non-inferiority to ceftriaxone plus azithromycin for urogenital 

, with no new safety concerns, offering a novel oral treatment option for uncomplicated urogenital gonorrhea,” the authors wrote.

Investigational Antibiotic Shows Efficacy, Safety in Late Stage Trial for Uncomplicated Gonorrhea



In 2023, the last year for counting confirmed statistics, there were 601,319 cases in the US.

This does demonstrate a slight 5-year decrease of 2.4%.

 According to the World Health Organization (WHO), there were 82.4 million cases in 2020. It is the second most prevalent STI behind chlamydia.

Last month, gepotidacin was FDA approved for uncomplicated urinary tract infections in female patients aged at least 12 years and weighing at least 40 kg. The approval is based on positive results from the pivotal phase 3 EAGLE-2 and EAGLE-3 trials which demonstrated non-inferiority to nitrofurantoin, one of the leading current standard of care options for uUTI, in female adults (≥40 kg) and paediatric patients (≥12 years, ≥40 kg) with a confirmed uUTI. In EAGLE-2, gepotidacin demonstrated non-inferiority in therapeutic success which occurred in 50.6% (162/320) of participants compared to 47.0% (135/287) for nitrofurantoin (covariate-adjusted treatment difference 4.3%, 95% CI (-3.6, 12.1)).

Clinical Implications, Study Takeaways of Gepotidacin For Uncomplicated UTIs

In EAGLE-3, gepotidacin demonstrated statistically significant superiority versus nitrofurantoin (one-sided p-value 0.0003). Therapeutic success occurred in 58.5% (162/277) of participants compared to 43.6% (115/264) for nitrofurantoin (covariate-adjusted treatment difference 14.6%, 95% CI (6.4, 22.8)).

The safety and tolerability profile of gepotidacin in the EAGLE-2 and EAGLE-3 phase III trials was consistent with previous trials. The most commonly reported adverse events (AEs) in gepotidacin participants were gastrointestinal (GI). Diarrhea was the most common (16% of participants), followed by nausea (9%). Of the participants who reported GI AEs in the gepotidacin group, the most common maximum severity was mild (69% Grade 1) and moderate (28% Grade 2). Participants with Grade 3 GI events accounted for 3% of all patients with GI events and occurred in <1% of all participants. There was one drug-related serious adverse event in each treatment arm (

 and nitrofurantoin) across the 2 trials.

GSK plans to file for FDA approval for treatment of gonorrhea later this year.




References

1. Ross J, et al. Oral gepotidacin for the treatment of uncomplicated urogenital gonorrhoea (EAGLE-1): a phase 3 randomised, open-label, non-inferiority, multicentre study. 

April 14, 2025. Accessed April 15, 2025.
DOI: 10.1016/S0140-6736(25)00628-2
2. Table 2. Trends in Reported Cases and Rates of Reported Cases for Nationally Notifiable STIs, United States. CDC. November 12, 2024. Accessed April 15, 2025.


https://www.cdc.gov/sti-statistics/data-vis/table-trends.html


3. Gonorrhea (Neisseria gonorrhoeae infection). WHO. July 4, 2024. Accessed April 15, 2025. https://www.who.int/news-room/fact-sheets/detail/gonorrhoea-(neisseria-gonorrhoeae-infection)
4. Blujepa (gepotidacin) approved by US FDA for treatment of uncomplicated urinary tract infections (uUTIs) in female adults and pediatric patients 12 years of age and older. GSK. March 25, 2025. Accessed March 25, 2025.
https://www.gsk.com/en-gb/media/press-releases/blujepa-gepotidacin-approved-by-us-fda-for-treatment-of-uncomplicated-urinary-tract-infections/



In a phase 3 study, GSK’s gepotidacin demonstrated 92% efficacy against the sexually transmitted infection. 

Kevin Schwartz, MD, MSc, FRCPC

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