STAT+: FDA to launch pilot program to speed up early-stage clinical trials

WASHINGTON — Federal health officials announced a pilot program Monday to speed up early-stage clinical trials, which they say will reduce development timelines by six to 12 months, in hopes of encouraging U.S.-based trials and combating Chinese dominance in the field.

The pilot comes as the Food and Drug Administration, through the president’s 2027 fiscal budget, asks Congress to establish a permanent, faster process for the existing Investigational New Drug pathway. That proposal was championed by former FDA Commissioner Marty Makary before he resigned last month, though officials said on a Monday morning call that this program had been in the works since the start of the administration.

In a Fox News op-ed, health secretary Robert F. Kennedy Jr. wrote that the U.S. is “losing ground” against China in clinical research and touted the actions as a way to reverse that trend.

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<![CDATA[FDA issues CRL for cytisinicline, citing manufacturing issues. ]]>

Confirmed Ebola cases in Congo outbreak top 1,000 with 254 deaths, authorities say

BUNIA, Congo — Confirmed cases in the Ebola outbreak in eastern Congo have reached 1,003, including 254 deaths, officials said, as tracing those who had been in contact with patients remains a major challenge.

A total of 100 people have recovered in the outbreak concentrated in the Ituri province since it was declared on May 15, Congo’s Ministry of Health said Sunday. At least 365 patients are in hospitals or in isolation, it said.

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<![CDATA[Pediatric experts link insomnia and mental health, favor CBT over sedatives, and warn against cannabis for sleep.]]>

Prevalence and Associations of Medical Expenditure Panel Survey–Defined Long COVID Among Adults: Cross-Sectional Study

<strong>Background:</strong> Long COVID is a clinical condition that significantly influences quality of life, productivity, and morbidity in the individuals affected. Much of the research to date has examined medical comorbidities and their associations with long COVID, but there remains a substantial need to understand the social and behavioral factors associated with long COVID. <strong>Objective:</strong> The objective of this study was to investigate the prevalence and associations of Medical Expenditure Panel Survey (MEPS)–defined long COVID among adults in the United States through the application of the Andersen behavioral model. <strong>Methods:</strong> This cross-sectional database study used the 2022 MEPS dataset. Variables in this analysis were organized according to the Andersen behavioral model. The appropriate weighting variable was used to obtain weighted population-based estimates. Between-group differences (ie, those with MEPS-defined long COVID vs those without) were assessed using chi-square tests, and a multivariable binomial logistic regression model was developed to assess the association between each variable and having MEPS-defined long COVID. <strong>Results:</strong> A total of 11,266 individuals were eligible for inclusion in this study. This represented a weighted population of 256,500,584 American adults. Of these 11,266 individuals, 790 (7%; weighted population=18,397,214) had MEPS-defined long COVID, whereas 10,476 (93%; weighted population=238,103,371) did not. Variables identified that were statistically associated with having MEPS-defined long COVID among American adults included 3 predisposing variables (age, sex, and Asian race), 2 enabling variables (marital status and employment status), 3 need variables (number of chronic conditions, health status, and instrumental activity of daily living limitations), 1 personal health practices variable (ever receiving the COVID-19 vaccine), and 1 external environmental variable (south region). <strong>Conclusions:</strong> The prevalence and factors associated with having MEPS-defined long COVID among American adults in this study offer insights to expand our limited understanding of the complex environmental and social factors associated with MEPS-defined long COVID. Further research is required among the long COVID population to better understand and differentiate the causes and consequences of this condition.

Brain-Infiltrating T Cells Linked to Social Deficits in Autism Mouse Model

The prevalence of autism spectrum disorder (ASD) is roughly one in 36 people, with a male-to-female ratio of 4:1. The disorder is known to be influenced by multiple factors, both genetic (gene mutations and copy number variations) and environmental, such as infections during pregnancy. However, the role of immunity in genetic ASD remains unclear.

One area of interest lies in lymphocytes—cells that are known to shape neurodevelopment and behavior. But their roles in neurodevelopmental disorders are not well defined.

Now, new research shows that a subset of T cells—γδ T cells—can infiltrate the brain and contribute to changes in social behavior in a genetic mouse model that mimics behavioral features of ASD. Depleting these cells from the brain increased sociability, suggesting that targeting abnormal immune function during neurodevelopment may offer interventions for ASD.

This work is published in Science Immunology in the paper, “CXCL16-mediated recruitment of γδ T cells to the brain reduces sociability in mice.”

Infections during pregnancy can induce the release of interleukin-17A (IL-17A) from T helper 17 cells and γδ T cells. Prior research has linked this type of maternal immune activation to neurodevelopmental disorders, but there is a lack of evidence connecting IL-17A and social behaviors in genetic mouse models.

To investigate this further, a team of researchers from the Division of Allergy and Immunology in the Medical Institute of Bioregulation at Kyushu University, in Fukuoka, Japan, studied 15q11-13 duplication (15q dup) mice—a mouse model that mimics a chromosome duplication found in some humans with ASD. These mice also demonstrate reduced social interactions, behavioral inflexibility, and increased anxiety-like behaviors.

The team analyzed immune cell populations in the brains of the 15q dup mice. Their findings suggest an increase in γδ T cells in the developing brains when compared with wild-type mice.

Using single-cell RNA sequencing (scRNA-seq), the team uncovered that this was most likely due to microglia in the brain expressing the chemokine CXCL16, which promotes immune cell migration. CXCL16 was highly expressed in the brains of 15q dup mice and contributed to increased infiltration of γδ T cells.

In addition, experiments revealed that deleting IL-17A–producing γδ T cells or blocking them with antibodies after birth increased sociability and reduced anxiety-like behaviors in the 15q dup mice.

Taken together, the authors note that these findings suggest that “immune dysregulation contributes to social behavior deficits in 15q dup mice, consistent with observations in maternal immune activation models, and may represent a potential target for interventions for ASD-associated differences in social behavior.”

The post Brain-Infiltrating T Cells Linked to Social Deficits in Autism Mouse Model appeared first on GEN – Genetic Engineering and Biotechnology News.

Breast Milk Fatty Acid Shapes Immune Development in Mice

In a new study published in Science titled, “Maternal trans-vaccenic acid shapes neonatal T cell development and early-life immune imprinting,” researchers from the University of Chicago have found that trans-vaccenic acid (TVA), the most abundant trans fatty acid in human breast milk, helps boost immune system development in mice. 

Nursing female mice that were fed a diet enriched with TVA passed the nutrient to their pups, leading to increased production of immune cells during early development. Genetic analyses showed that TVA exposure during breastfeeding reprogrammed immune cells to improve responses to pathogens. Mice that were nursed on TVA-enriched milk responded faster to infections with viruses or common bacteria, even into adulthood. 

“It’s common knowledge that breastfeeding is important for neonatal immune development and overall health, but breast milk is so complex that it seems almost impossible that one single molecule would be sufficient to change a baby’s immune development,” said Jing Chen, PhD, professor of medicine at UChicago and co-corresponding author on the study. “So, it was very surprising to see that during this crucial stage of development, one nutrient derived from the mother’s diet and delivered through breastfeeding has such a tremendous effect.” 

TVA is a long-chain fatty acid found in meat and dairy products from grazing animals such as cows and sheep. The human and mouse body must obtain TVA through diet.  

Pups who were nursed by mothers with a diet enriched with TVA demonstrated a broader and more effective immune cell population, particularly CD4+ T cells that are important for adaptive immunity. Mice raised on TVA-enriched breast milk responded more quickly and had higher survival rates when exposed to the flu virus or Salmonella. 

“We saw that only postnatal exposure to TVA through breastfeeding is important to train the neonatal T cells, and this can have long-lasting imprinting effects,” Chen said. “Even in adulthood, when we challenged the mice with influenza, the ones that were exposed to higher TVA levels during breastfeeding responded better when battling the infection.” 

The team also analyzed TVA levels in breast milk and blood samples from human nursing mothers and infants. They found that higher TVA levels in breast milk were closely linked to higher TVA levels in infants’ blood. In preterm infants, levels of circulating TVA correlated with similar shifts in immune responses seen in mice.

Higher TVA levels in human breast milk were also associated with reduced risk of bronchopulmonary dysplasia, a chronic inflammatory lung disease that affects premature infants with underdeveloped lungs and increased susceptibility to respiratory infection. 

Chen hopes for more research on the possibilities for supplementing diets with TVA during pregnancy and breastfeeding, or infant formula. The team will also investigate additional fatty acids and nutrients found in breast milk to understand their benefits. 

“There are close to 40 fatty acids in total in breast milk, along with hundreds of other components,” Chen said. “So, I think it’s safe for us to say that we believe there could be additional fatty acids and nutrients that can do something similar.” 

The post Breast Milk Fatty Acid Shapes Immune Development in Mice appeared first on GEN – Genetic Engineering and Biotechnology News.

<![CDATA[Phase 3 results show single-dose DT120 lysergide ODT delivers rapid, lasting relief in major depressive disorder with mild, transient adverse effects.]]>

STAT+: Another big deal, another sign biotech M&A is back

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Good morning! Pharma companies are on a biotech buying spree, an LSD pill just delivered unusually strong late-stage depression data, and the FDA reverses course of Regenxbio’s treatment.

Also: Today, thousands of industry players (and me!) are gathering in San Diego for BIO to talk deals, science, and whatever comes next. Check out the last item for a jaunt down memory lane about the conference.

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