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Interim President and CEO and Director of Arbutus Biopharma.

Arbutus CEO Michael McElhaugh discussed trial results showing that a combination of imdusiran, an RNAi therapeutic, and pegylated interferon alfa-2α can achieve a functional cure in chronic hepatitis B patients.

Imdusiran for Chronic Hepatitis B Achieves Functional Cure in 50% of Patients

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 panel discusses therapies and care around inpatients including mechanical ventilation, extracorporeal membrane oxygenation (ECMO), and remdesivir.

COVID-19 THERAPY Roundtable: Addressing Inpatient Clinical Care

According to the Centers for Disease Control and Prevention, the week ending November 30, 2024, there has been a rate of 0.8 hospitalizations per 100,000 people, and this shows a good downward trend over the last few weeks.

Although the number of hospitalizations have decreased significantly since the beginning of the pandemic, there are waves where incidence rates increase and a number of people who are contracting severe cases of COVID-19 need to be hospitalized.

During the height of the pandemic and before the development of vaccines and therapies, there were therapeutic limitations and patients could be put on mechanical ventilation or extracorporeal membrane oxygenation (ECMO).

ECMO was utilized more frequently in a time when there was not other treatments. And in some select cases, James Wilson, DO, FACP, FAWM, CTropMed, says ECMO did show some benefit, and there might be some select situations where it might be warranted but overall he says treatment protocols have changed considerably since 2020.

“If they're breathing at 40 times a minute for more than an hour, you're going to have to do it [ECMO],” Wilson. “But now we have modalities to treat those patients.”

One of the treatments that emerged was remdesivir for inpatients with severe COVID-19.

“I triage COVID between requiring oxygen and not requiring oxygen,” said Scott Roberts, MD, associate medical director of Infection Prevention, Yale School of Medicine. “And then once you become severe enough to require it, we really start remdesivir as soon as we can in the inpatient setting. And we know from many studies at this point there are reductions in mortality in those who do receive remdesivir. We use it for all really severe patients.”

This is episode 2 of our 4-part series. Check back for future episodes.

Reference
1.COVID Tracker. CDC. Accessed December 10, 2024.
https://covid.cdc.gov/covid-data-tracker/#covidnet-hospitalization-network

In this week's episode, the panel discusses therapies and care involving inpatients, including mechanical ventilation, extracorporeal membrane oxygenation (ECMO), and remdesivir.

COVID-19 Therapy Roundtable: Addressing Inpatient Clinical Care 

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, 

 is a vegetative cell, so a bacterium that produces two really potent toxins that cause disease, but 

 also makes a spore, and this spore is really, really hard to kill and survive outside of the body, but even when it’s inside the body, it can be really challenging for antibiotics to kill, can be challenging for our own immune systems to kill," Zackular explained.

Despite these challenges, the vaccine developed in his lab has shown the potential to reduce the severity of disease. While it has not yet prevented the initial colonization of 

 in animal models, the vaccine significantly reduced mortality and improved outcomes.

 from being able to colonize and cause infection, but that’s challenging. It's an organism that lives in this relatively hard-to-get-to part of our body, the lumen of the gut, and it doesn’t invade. And so being able to prevent it from colonizing, of course, can be challenging,” Zackular said.

In studies with a highly virulent strain of 

, the vaccine prevented 100% of mortality in mice, which is a remarkable outcome. “What we found is that we aren’t able to prevent the initial colonization and outgrowth of this pathogen. However, we are able to find that we can dramatically stunt the pathogenicity and the disease that's caused by this really problematic infection,” he added.

This vaccine uses the mRNA platform, which has already proven successful in COVID-19 vaccines. Zackular's team has developed a tetravalent vaccine targeting both toxins responsible for 

’s harmful effects and the bacterial cell and spores.

“This mRNA vaccine platform allows us to create multivalent vaccines very readily. And so what we’re able to do in this paper was make a tetravalent vaccine that targets both of the really important toxins that cause disease with 

, but also target the cell itself as well as the spore,” Zackular explained.

The research represents a promising proof of principle that mRNA vaccines could be effective in preventing 

 disease. Looking forward, the team hopes to further refine the vaccine, targeting more virulence factors and potentially preventing initial infection or promoting quicker bacterial clearance.

“Ultimately, in the future, we’re hopeful that we can add even more targets against the cell, against the spore, against other virulence factors that might allow us to prevent initial infection, or at least clear even quicker,” Zackular said.

Stay tuned for part 2 of our interview where we discussed the complexities of 

 infections, often recurrent due to antibiotic-induced disruption of the gut microbiome and more.

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.


We’re starting to see the early signs of a winter surge; cases are rising in the United States and abroad. This winter will be a test. Our first winter in which people have collectively decided “the pandemic is over.” 

From President Biden’s comments to the non-existence of public health interventions in place, and even the challenges in getting people boosted with the bivalent shot, it seems as if the United States is officially done with COVID-19. Unfortunately, it’s not done with us. We’ve seen this though. Last winter, just before Thanksgiving, it felt the same. People were traveling again, saying the pandemic was over, and then Omicron hit.

As we wait to see what this winter brings, one worry comes to mind: we’ve been banking a lot on the vaccines and how they reduce severe disease and death, but what happens when people stop getting vaccinated and lose that protection? 

The protection from vaccines is wonderful but if we stop getting boosted, what does this mean for COVID-19 morbidity and mortality? A new 

 recently broke down hospitalizations associated with COVID-19 in adults between January 2021 and April of this year, based upon vaccination status. The research team performed a cross-sectional study and ultimately found that those hospitalizations associated with COVID-19 were 10.5 times higher in unvaccinated persons. Moreover, those vaccinated individuals who had not been boosted had a 2.5 times higher hospitalization rate when compared to those who were boosted. 

The 192,509 hospitalizations assessed were telling in terms of the fluctuation in cases and hospitalization, which ranged in terms of monthly rates from 3.5 times to 17.7 higher in unvaccinated persons. “For July 2021 to December 2021 (Delta period) and January to April 2022 (Omicron period), cumulative hospitalization rate ratios in unvaccinated persons compared with vaccinated persons, regardless of booster dose status, were 12.2 (95% CI, 12.0-12.4) and 6.8 (95% CI, 6.6-6.9) for all adults 18 years or older, respectively. From January to April 2022, rates were 10.5 (95% CI, 10.2-10.8) and 2.5 (95% CI, 2.2-2.8) times higher in unvaccinated persons and vaccinated persons with no booster dose, respectively, compared with those who had received a booster dose (data not shown).”

The authors shared some interesting findings as well. The median time from most recent vaccine dose until hospital admission was 180 days in vaccinated cases, who also happened to be older and more likely to be White and residents of long-term care facilities (LTCF). Moreover, those vaccinated individuals who were hospitalized for COVID-19, were more likely to have immunosuppression when compared to unvaccinated cases, as we as having 3 or more underlying medical conditions. The authors also noted that, “The proportion of vaccinated persons admitted to the ICU was similar to that among unvaccinated persons (505 [19.5%] vs 1961 [21.7%], respectively; 

 = .13), as were proportions for in-hospital death (216 [10.1%] vs 802 [9.9%], respectively; 

 = .89). Median length of stay in vaccinated persons was shorter (median, 4.3 days [IQR, 1.9-8.9] vs 4.6 days.” 

Ultimately, these findings underscore the importance of not only being vaccinated, but also boosted. For those of advanced age and with underlying medical conditions, it’s important to stay up-to-date (e.g. boosted) to avoid hospitalizations.

A recent study broke down hospitalizations associated with COVID-19 in adults between January 2021 and April of this year, based upon vaccination status.

COVID-19 Hospitalizations Broken Down by Vaccination Status

Hepatitis D (HDV) only infects people who have hepatitis B. And this form of 

 continues to be the most virulent and can quickly decompensate to liver disease. Bulevirtide monotherapy is both safe and well-tolerated in patients with chronic hepatitis delta (CHD) through 48 weeks of use, according to recent findings.

These findings resulted from a new study assessing safety and tolerability of bulevirtide, with an integrated analysis of clinical trial findings from those with chronic hepatitis delta.

This analysis was authored in part by Tarik Asselah, MD, PhD, from the department of hepatology at the Université de Paris-Cité Hôpital Beaujon. Bulevirtide was approved in Europe, and additional data was then released confirming the drug’s efficacy and safety.

“In this integrated analysis of data derived from completed and ongoing clinical trials, we describe the safety and tolerability of [bulevirtide] therapy after 48 weeks of treatment among patients with CHD and compensated liver disease,” Asselah and colleagues wrote.

The investigative team evaluated safety of bulbertide through the combination of information from 3 multi-center, open-label, randomized phase 2 and 3 clinical studies. These analyses assessed the implementation of bulevirtide for the treatment of CHD, with subjects in the trials being given either 2 mg or 10 mg of bulevirtide, pegylated interferon-alpha (Peg-IFNα) as a reference treatment, or no anti-HDV therapy as part of a delayed-treatment control group featured in the MYR301 study.

All of these treatments were administered by the team as monotherapy for a duration of 48 weeks. These studies, specifically identified as MYR203, MYR204, and MYR301, were carried out within 7 countries: Germany, Romania, Italy, France, Russia, and Sweden.

Criteria for participants to be eligible for the studies included men and women in the age range of 18 - 65 years. Additionally, other criteria were having CHD with or without compensated cirrhosis, detectable HDV RNA at the time of one's screening, and elevated ALT levels.

During the study, the investigators administered the 10 mg dose of bulevirtide as two 5 mg subcutaneous injections, maintaining the 2 mg dose as a single injection.

In terms of specific districution, the subjects were placed into 4 cohorts: bulevirtide 2 mg (64 individuals), bulevirtide 10 mg (115 individuals), Peg-IFNα (39 individuals), and a delayed-treatment control arm (51 individuals).

The researchers found that certain adverse events (AEs) had taken place more frequently among those treated with bulevirtide compared to those in the control arm of the analyses.

The AEs included injection-site reactions (16% with bulevirtide 2 mg, 20% with bulevirtide 10 mg, and 0% in the control), increased total bile acid levels (20% with 2 mg, 17% with 10 mg, and 0% in the control), headache (16%, 17%, and 0%, respectively), itch (11%, 10%, and 0%, respectively), and eosinophilia (9%, 4%, and 0%, respectively).

Although increases in total bile acid levels were noted by the investigators with bulevirtide, they found no clear connection between such increases and other AEs such as eosinophilia, itch, or vitamin D deficiency.

AEs labeled as Grade 3 or 4 that were observed to be connected to the study drug took place more often in the Peg-IFNα cohort (51%) compared to participants receiving bulevirtide 2 mg (3%) or 10 mg (4%).

Notably, no serious AEs were found to be linked to bulevirtide therapy. They added that no subjects discontinued the treatment resulting from AEs. Additionally, there were no cases of hepatic decompensation and no cases of death reported in any of the treatment cohorts.

“In conclusion, this integrated analysis of [bulevirtide] treatment through 48 weeks did not identify any new safety concerns associated with [bulevirtide] monotherapy at either dosage relative to previously published data,” they wrote. “[Bulevirtide] has been shown to demonstrate a consistent and predictable tolerability and safety profile, which is more favourable than Peg-IFNα alone.”

1.Asselah, T., Lampertico, P., Aleman, S., Bourlière, M., Streinu-Cercel, A., Bogomolov, P., Morozov, V., Stepanova, T., Lazar, S., Manuilov, D., Mercier, R.-C., Tseng, S., Ye, L., Flaherty, J.F., Osinusi, A., Da, B.L., Chee, G.M., Lau, A.H., Brunetto, M.R. and Wedemeyer, H. (2024), Bulevirtide Monotherapy Is Safe and Well Tolerated in Chronic Hepatitis Delta: An Integrated Safety Analysis of Bulevirtide Clinical Trials at Week 48. Liver Int. https://doi.org/10.1111/liv.16174.
2. E. Degasperi, M. P. Anolli, S. C. Uceda Renteria, et al., “Bulevirtide Monotherapy for 48 Weeks in Patients With HDV-Related Compensated Cirrhosis and Clinically Significant Portal Hypertension,” Journal of Hepatology 77, no. 6 (2022): 1525–1531.

In a study evaluating bulevirtide as monotherapy, investigators found the antiviral to be safe and tolerable following nearly a year of treatment.

Canonical

Investigational Hepatitis D Therapy Well-Tolerated, Safe for Chronic Disease at Week 48

A small phase 2 study evaluated Debiopharm’s investigational antibiotic, afabicin, including its clinical response rate and safety profile of 2-3 weeks 

Early-Stage Antibiotic for Bone and Joint Infections Comparable to Standard of Care Therapy

One source of bone and joint infections (BJI) can be from recent surgery including joint replacement procedures. It is estimated that over 2.9 million joint replacements are done globally every year.

BJI include osteomyelitis, septic arthritis, and prosthetic joint infections and affect over 30,000 people per year within the US, UK, France, Germany, Spain and Italy combined.

These infections can be especially troublesome to treat for a number of reasons including resistance to 

, blood flow sources to bones and also the time of treatment, which can typically be 4-6 weeks, with antibiotics that can cause toxicity and lead to adverse effects.

This last component of treatment toxicity can be very problematic according to Alireza Shamaei-Tousi, PhD, principal clinical scientist, Debiopharm.

"There is issues with safety and monitoring of some of these patients. For example, if you use vancomycin, it can be associated with cytopenia and ototoxicity,” Shamaei-Tousi said. "Also, if you use linezolid, because of cytopenia and other toxicity issues, the patient can only be given linezolid for 28 days. So you see there is an issue that becomes apparent if you want to have 6 weeks of treatment.” 

Debiopharm, a privately-owned, Swiss-based, biopharmaceutical company is in a phase 2 trial evaluating its investigational antibiotic, afabicin, for the treatment of BJI due to staphylococci.

Shamaei-Tousi presented a poster, Results from A Phase 2 Clinical Trial for Treatment of Bone And Joint Infections with Afabicin, A First-in-Class Selective Anti-Staphylococcal Antibiotic, at the recent ID Week conference.

This was a small study including 20 patients in the first cohort of the overall study and included 2-3 weeks of treatment.

Shamaei-Tousi says afabacin is available in both IV and oral treatment. This might be an option for patients requiring longer treatment who may start with the former and can be switched to oral after discharge. 

Study participants included in the study had osteomyelitis, septic arthritis, or prosthetic joint infections, and were randomized with 5 afabicin vs 1 standard of care (SoC) to receive IV and oral treatment for 14 to 21 days. Afabicin treatment was administered as 55 mg IV/ 80 mg PO BID, and was compared to a pre-defined SoC treatment, according to the investigators.

Seventeen patients were administered afabicin and 3 were given SoC. The mean treatment duration was 20.1 days for the afabicin arm, and 19.7 days for the SoC arm. Osteomyelitis was identified in 85% of the participants, and 

 was in 19 patients and 18 patients had methicillin-sensitive 

The investigators reported that all of the participants responded to treatment with a a clinical response at 4 weeks post end of treatment (EoT) was 13 of 15 patients in the afabicin arm. All 3 patients in the SOC arm achieved clinical response at 4 weeks post EoT. 

At 12 weeks post EoT, the clinical response rate was 13 of 15 patients in the afabicin arm and 2 of 3 patients in the SoC arm. The investigators noted a similar safety profile was observed in the afabicin cohort vs the SoC cohort. 3

“The clinical response rate and safety profile of 2-3 weeks treatment of staphylococcal BJI with afabicin was comparable to SoC. These data support exploring longer durations of treatment in the study,” the investigators wrote.

Debiopharm is working on treatments to cure cancer and treat infectious diseases. The company is developing microbiome-sparing pathogen-specific FabI inhibitors, a new class of antibiotics with novel mechanism of action. Afabicin, the most advanced FabI inhibitor in the pipeline, inhibits the fatty acid synthesis in staphylococci by targeting the Fabl enzyme. According to the Debiopharm, the therapy fulfills all 4 World Health Organization’s 2020 innovativeness criteria, including it’s a new chemical class, new target, a new mode of action and no cross-resistance to other antibiotic classes. 

A small phase 2 study evaluated Debiopharm’s investigational antibiotic, afabicin, including its clinical response rate and safety profile of 2-3 weeks of treatment for staphylococcal bone and joint infections (BJI). 

Michael J McElhaugh

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