The coordination of speaking and breathing by the brain : The study

Researchers from MIT have discovered a brain circuit that drives vocalization and ensures that you talk only when you breathe out, and stop talking when you breathe in.

The study, published in the Journal Science, highlights a newly identified circuit governing two essential vocalization actions: larynx narrowing and lung exhalation. Located in the larynx, the vocal cords are two muscular bands that can open and close. When they are mostly closed, or adducted, air exhaled from the lungs generates sound as it passes through the cords.

Additionally, researchers also discovered that this vocalization circuit is commanded by a brainstem area regulating breathing rhythm, thereby prioritizing breathing over speech.

“When you need to breathe in, you have to stop vocalization. We found that the neurons that control vocalization receive direct inhibitory input from the breathing rhythm generator,” said Fan Wang, an MIT professor of brain and cognitive sciences, a member of MIT’s McGovern Institute for Brain Research, and the senior author of the study.

For the study, the MIT researchers investigated how the brain controls vocalization in mice, who communicate through ultrasonic vocalizations (USVs). By mapping synaptic connections between neurons, they traced back from laryngeal motor neurons controlling vocal cord adduction to identify the neurons innervating them.

The findings revealed that specific RAm neurons, active during ultrasonic vocalizations (USVs), are essential for vocalization. Targeting these neurons, called RAmVOC, and manipulating their activity revealed that blocking them prevents vocalization because the vocal cords remain open and abdominal muscles don’t contract as usual during exhalation. Conversely, activating RAmVOC neurons leads to vocalization: vocal cords close, mice exhale, and USVs are produced. However, prolonged stimulation causes interruptions by inhalations, indicating the process is regulated by the brain’s breathing control center.

“Breathing is a survival need. Even though these neurons are sufficient to elicit vocalization, they are under the control of breathing, which can override our optogenetic stimulation,” said Wang.

Reference: JAEHONG, SEONMI CHOI, JUN TAKATOH, SHENGLI ZHAO, ANDREW HARRAHILL, BAO-XIA HAN, AND FAN WANG; Journal: Science; DOI: 10.1126/science.adi8081

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Vitamin A could have a key role in both stem cell biology and wound healing: Study

A new study published in the Journal Science demonstrated that once stem cells have transitioned into lineage plasticity, they are unable to operate efficiently until they commit to a specific fate. During a screening process to identify crucial regulators of this phenomenon, retinoic acid, the active form of Vitamin A, emerged unexpectedly as a significant factor.

Lineage plasticity, observed in various tissues in response to injury and in cancer, is best studied in minor skin injuries due to the skin’s constant exposure to damage. When scratches or abrasions damage the epidermis, hair follicle stem cells are the first to respond, with other skin stem cells following suit to regenerate the skin. Some stem cells, originally dedicated to hair growth, transition into epidermal stem cells to aid in repair. This transition involves temporary expression of transcription factors from both hair and epidermal stem cells.

“Our goal was to understand this state well enough to learn how to dial it up or down,” said Elaine Fuchs professor at Rockefeller University. “We now have a better understanding of skin and hair disorders, as well as a path toward preventing lineage plasticity from contributing to tumor growth.”

The researchers explored lineage plasticity, highlighting its dual role: crucial for directing stem cells to areas needing repair, yet potentially leading to prolonged repair states and certain cancers if uncontrolled. To understand the mechanism, they screened small molecules in cultured mouse hair follicle stem cells, mimicking wound conditions were surprised to find that retinoic acid, the active form of vitamin A, was essential for these stem cells to exit lineage plasticity and differentiate into hair or epidermal cells in vitro.

“Through our studies, first in vitro and then in vivo, we discovered a previously unknown function for vitamin A, a molecule that has long been known to have potent but often puzzling effects on skin and many other organs,” said Fuchs.

The findings revealed that genetic, dietary, and topical interventions boosted or removed retinoic acid from mice and confirmed its role in balancing how stem cells respond to skin injuries and hair regrowth. Retinoids did not operate on their own: their interplay with signalling molecules such as BMP and WNT influenced whether the stem cells should maintain quiescence or actively engage in regrowing hair.

“By defining the minimal requirements needed to form mature hair cell types from stem cells outside the body, this work has the potential to transform the way we approach the study of hair biology,” said Matthew Tierney, lead author of the paper.

Reference: MATTHEW T. TIERNEY, LISA POLAK, YIHAO YANG, MERVE DENIZ ABDUSSELAMOGLU, INWHA BAEK, KATHERINE S. STEWART, AND ELAINE FUCHS; Journal: Science; DOI: 10.1126/science.adi7342

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Preoperative urine culture fails to lower postoperative UTI risk: JAMA

A recent cohort study published in the Journal of American Medical Association unearthed the crucial insights that challenge the conventional practice of conducting preoperative urine cultures before nongenitourinary surgeries. Despite the prevailing guidelines that advise against this practice, many clinicians still resort to preoperative urine cultures and antibiotics administration for asymptomatic bacteriuria to reduce infection risks.

The study was conducted across 112 US Department of Veterans Affairs (VA) medical centers from January 2017 to December 2019 and scrutinized over 288,000 surgical procedures performed on VA enrollees. This research utilized machine learning and inverse probability of treatment weighting (IPTW) and meticulously balanced patient characteristics between those who underwent preoperative urine cultures and those who didn’t.

The findings revealed that preoperative urine cultures held no significant association with a reduced risk of postoperative urinary tract infections (UTIs) or surgical site infections (SSIs). According to the IPTW analysis, the preoperative urine cultures were performed in 10.5% of the surgical procedures, while the adjusted odds ratios (AORs) for both UTI and SSI post-surgery remained largely unaffected. Even when focusing on orthopedic and neurosurgery cases that often involved prosthetic implants, this study found no link between preoperative urine cultures and reduced infection risks.

The study emphasized that these findings underline the need to reconsider the routine practice of preoperative urine cultures and subsequent antibiotic treatments before surgeries in cases involving prosthetic implants. The results advocate for the deimplementation of this practice which aligns with the recent guidelines that discourage such preoperative screenings.

Source:

O’Brien, W. J., Schweizer, M. L., Strymish, J., Beck, B. F., Au, V., Chan, J. A., Brown, M., Itani, K. M. F., Dukes, K. C., Walhof, J. F., & Gupta, K. (2024). Propensity Score-Weighted Analysis of Postoperative Infection in Patients With and Without Preoperative Urine Culture. In JAMA Network Open (Vol. 7, Issue 3, p. e240900). American Medical Association (AMA). https://doi.org/10.1001/jamanetworkopen.2024.0900

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Silver Diamine Fluoride a Game-Changer in School-Based Dental Care, proposes study

Dental
caries, the most prevalent noncommunicable disease globally, poses a
significant health equity challenge. In a recent pragmatic clinical trial,
researchers have explored the efficacy of Silver Diamine Fluoride (SDF) as a
potential alternative to traditional dental sealants and atraumatic restorative
treatment (ART) for preventing and controlling dental caries. The study found
that SDF application resulted in
nearly identical caries incidence compared to traditional dental sealants and
ART, showcasing noninferiority in the longitudinal prevalence of caries.


The trial results were published in the journal
JAMA Pediatrics.

Also Read: Children with sleep disorders, anxiety, obesity and dry mouth more likely to have dental caries: Study

Dental caries, a
prevalent global noncommunicable disease, impacts 50% of US children aged 6 to
8. Despite Medicaid expansions, more than 69 million individuals in the US face
access challenges. Hence, researchers conducted a trial, exploring the
effectiveness of Silver Diamine Fluoride, aiming to address these issues and
contribute valuable insights for improved oral health outcomes.

The CariedAway study sought to determine
whether the application of SDF in schools is non-inferior to traditional dental
sealants and atraumatic restorative treatment (ART) in the prevalence of dental
caries.

The trial targeted children in primary schools in New York City,
specifically those with a demographic composition of at least 50% Black or Hispanic
students and at least 80% receiving free or reduced lunch, a population
identified as being at the highest risk of caries in New York.

This pragmatic noninferiority
cluster-randomized clinical trial enrolled a total of 7418 children aged 5 to
13 years. The participants were randomly assigned at the school level to
receive either a 38% concentration SDF solution or traditional glass ionomer
sealants with ART. Additionally, each participant received fluoride varnish. The
primary outcomes of interest were the prevalence and incidence of dental
caries. A total of 7418 children aged 5 to 13 years were enrolled, with 4100
completing follow-up.


Findings:

  • Following initial treatment, 55.0% of
    participants completed at least one follow-up observation.

  • The baseline
    prevalence of dental caries stood at approximately 27.2%, with a significant
    decrease in the odds of decay prevalence over time (odds ratio [OR], 0.79).
  • Notably, SDF demonstrated noninferiority compared to traditional sealants and
    ART (OR, 0.94).
  • The incidence of dental caries in children treated with SDF
    closely mirrored that of those treated with sealants and ART, highlighting
    noninferiority in caries prevention.
Also Read: Dental Caries: Practitioners’ Perspective and Rationale for Using Aceclofenac and Paracetamol Combination Treatment in its Management


The CariedAway study’s findings propose a
potential revolution in school-based dental care, challenging the conventional
approach to preventing and managing dental caries. By suggesting that SDF may
be as effective as traditional sealants and ART, the study opens the door to a
more accessible and potentially equitable solution for preventing the world’s
most prevalent noncommunicable disease.

As this research sparks renewed interest and
discussion in the dental health community, further studies and long-term
observations will be crucial to validate these findings. If substantiated, the
introduction of SDF could herald a transformative era in school-based dental
care, offering hope for improved oral health outcomes, particularly among
vulnerable populations.

Further reading: Ruff RR, Barry Godín TJ, Niederman R. Noninferiority of Silver Diamine Fluoride vs Sealants for Reducing Dental Caries Prevalence and Incidence: A Randomized Clinical Trial. JAMA Pediatr. Published online March 04, 2024. doi:10.1001/jamapediatrics.2023.6770

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Pulse Oximeters Overestimate Oxygen Saturation in people with Darker Skin Tone: Study

Pulse oximetry is commonly used to measures oxygen levels in the blood non-invasively. However, concerns have arisen regarding its reliability in individuals with darker skin tones. A recent review published in the British Journal of Anaesthesia explored the accuracy of pulse oximeters in estimating arterial oxygen saturation (SaO2) across different skin tones.

This comprehensive review encompassed a total of 44 studies and over 222,000 participants and found that pulse oximeters tended to overestimate SaO2 in individuals with darker skin tones. While the majority of studies reported this bias, a few indicated no significant inaccuracy related to skin tone.

Despite the extensive data sieved through, meta-analysis could not be conducted due to the considerable heterogeneity in study design and reporting metrics. Importantly, only a quarter of the studies measured skin tone directly, while the others relied on participant ethnicity, with approximately 31% of participants being of non-White ethnicity or having non-light skin tones. The review emphasized the importance of recognizing this bias in pulse oximetry that can overestimate true SaO2 in people with darker skin tones. 

This finding raises critical concerns in medical scenarios where accurate oxygen saturation readings are paramount for the management of the patients. While the exact impact of this bias on clinical outcomes requires further investigation, the awareness of its existence is crucial for healthcare providers.

The study illuminates the need for improved diversity and inclusion to address disparities in healthcare outcomes across different demographic groups. The outcomes prompt healthcare professionals to remain cautious and consider the potential inaccuracies when interpreting oxygen saturation readings, particularly in patients with darker skin tones.

Source:

Martin, D., Johns, C., Sorrell, L., Healy, E., Phull, M., Olusanya, S., Peters, M., & Fabes, J. (2024). Effect of skin tone on the accuracy of the estimation of arterial oxygen saturation by pulse oximetry: a systematic review. In British Journal of Anaesthesia. Elsevier BV. https://doi.org/10.1016/j.bja.2024.01.023

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Ceramide plus natural moisturizing factor-enriched cream and lotion markedly improves skin moisturization: Study

USA: The utilization of a moisturizer (lotion or cream) that contains both natural moisturizing factors (NMFs) and ceramides is better than a ceramide cream alone for improving barrier function, maintaining skin hydration, and reducing the clinical sequela linked with dry skin, says a new study.

“The marked improvement in skin moisturization following utilization of the formulation of ceramide plus MMF-enriched lotion and cream versus ceramide-based cream can be due to the inherent properties of the natural moisturizing factors,” the researchers wrote in the Journal of Drugs in Dermatology.

These properties are known to maintain the stratum corneum’s intercellular lipid membrane and humectancy, which directly improves the permeability barrier function of human skin in decreasing transepidermal water loss.

The skin is a complex barrier composed of stratified epidermis, dermis, and subcutaneous tissue. The skin’s primary function is to maintain a physical barrier against external exposures, preventing entry of harmful substances and maintaining physiologic water content. The epidermis’ permeability barrier function prevents excessive fluid gain or loss from the body within the stratum corneum (SC), the outer portion of the epidermis.

When the skin is compromised by external and exogenous environmental exposures, permeability barrier function is compromised leading to increased transepidermal water loss (TEWL). This predisposes the skin to adverse sequelae of xerosis; decreased resiliency; microfissuring; natural elastic recoil, scaling, and hyperkeratosis; and an increased risk of microbial infections. The water content inside the SC is required to maintain the functional and structural integrity of the skin and the multiple functions of the skin barrier.

Topical skincare products, including lotions, creams, and ointments have been used widely to protect and maintain skin barrier structure and function. Ceramides are frequently included ingredients in many topical skin moisturizers due to their established major importance in skin barrier functions, and their impairment and/or quantitative reduction in several environmental or disease-associated scenarios; many formulations also have NMFs to further enhance the maintenance of skin barrier function by including compounds found in the innate epidermal barrier.

Against the above background, Hilary E. Baldwin, Acne Treatment and Research Center, Brooklyn, NY, and colleagues aimed to examine the effects of 2 ceramide plus NMF-enriched formulations versus a ceramide-based cream on skin moisturization.

For this purpose, the research team conducted two double-blinded comparative studies enrolling 35 (n=29 females, n=6 males) and 33 (n=21 females, n=12 males) participants. Participants applied ceramide plus natural moisturizer cream or ceramide-based cream (study 1) or applied ceramide plus natural moisturizing factor lotion or ceramide-based cream (study 2). The cram was applied to their lower legs for ten days with a 5-day regression period (no moisturizer applied).

The researchers conducted skin hydration by corneometry after bilateral application once daily for each leg in both groups.

The researchers found an increase in corneometer units vs baseline for the ceramide plus NMF-enriched cream and NMF-enriched lotion to be greater than the increase versus baseline for the ceramide-based cream at days 10 and 15. An overall statistical significance favored the ceramide plus natural moisturizing factor-enriched formulations at day 10.

Reference:

doi:10.36849/JDD.8172

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Tandem cycling may improve health of those with Parkinson’s and their care partners

Pedaling on a stationary bicycle built for two may improve the health and well-being for both people with Parkinson’s disease and their care partners, according to a small, preliminary study released today, February 29, 2024, that will be presented at the American Academy of Neurology’s 76th Annual Meeting taking place April 13-18, 2024, in person in Denver and online.

“Our study found that a unique cycling program that pairs people with Parkinson’s disease with their care partners can improve the physical, emotional and mental well-being of both cyclists to improve their quality of life,” said Jennifer Trilk, PhD, of the University of South Carolina School of Medicine in Greenville. “It is just as important that care partners also receive care, so that is why we included them as the cycling partner. The goal of our small study was to determine if tandem cycling was beneficial. The next step will be to confirm the results with subsequent studies that would include more participants.”

The study included 18 participants, nine with Parkinson’s disease and their corresponding nine care partners.

For the tandem cycling program, pairs of people with Parkinson’s disease and their care partners cycled on indoor, stationary tandem bicycles while using a virtual reality platform two times per week for eight weeks. During each session, all participants could visualize themselves cycling along real life, scenic outdoor routes by watching large television screens that were synced to the cycling intensity. The tandem cycling set-up also allowed the care partners to help adjust the cycling pace and facilitate a higher pedaling rate for greater health benefits.

Prior to starting the cycling program, all participants completed a series of tests. Participants repeated the same tests two days after the final cycling session eight weeks later.

For a test of resiliency, participants ranked a series of six statements regarding their perceived ability to bounce back or recover from stress. Statements were ranked on a scale of one to five, with higher numbers indicating stronger agreement. Statements included “I tend to bounce back quickly after hard times” and “I usually come through difficult times with little trouble.”

While people with Parkinson’s disease did not show improvements in resiliency, researchers found care partners demonstrated individual improvements in overall resiliency, which Trilk noted may help to decrease care partner burden. Care partners also demonstrated statistically significant improvements in depression scores after the cycling intervention.

Those with Parkinson’s disease completed additional disease-associated tests, including a questionnaire on how often they experience difficulties in daily living, including relationships, social situations and communication. They also completed physical tests, including a test used to gauge the severity and progression of their disease as well as a walking speed test.

People with Parkinson’s disease improved across their respective tests.

In the test measuring overall perception of difficulties in daily living, where higher scores indicate a lower quality of life, on a scale of zero to 100, participants decreased their total score by nearly five points, indicating improved overall quality of life. Participants with Parkinson’s disease also showed significant improvements in mobility on this test, in which they had a decrease of nearly 14 points, indicating improved overall physical function.

Researchers also found that participants with Parkinson’s disease had a decrease of eight points in the test gauging the overall motor severity and progression of their disease, where higher scores indicate greater disease burden. Overall scores range from zero to 132.

They also improved their walking speed, with an increase of 0.27 meters per second.

Reference:

Tandem cycling linked to improved health for those with Parkinson’s, care partners, American Academy of Neurology, Meeting: 2024 American Academy of Neurology’s 76th Annual Meeting.

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Type 2 diabetes no longer a barrier to becoming living kidney donor

People who are overall healthy and living with well-controlled Type 2 diabetes can donate a kidney, thanks to a change in national policy.

The Organ Procurement and Transplantation Network updated itsliving donor criteria . It makes some people with Type 2 diabetes eligible to donate a kidney. This marks a “significant shift” in criteria for living kidney donors, says Naim Issa, M.D ., Mayo Clinic transplant nephrologist.

“This policy change may offer a lifeline to some people with end-stage kidney disease, providing them with a better chance for a successful transplant and improved quality of life,” he says.

Nearly 89,000 people in the U.S. are on the waiting list for a potentially lifesaving kidney transplant, according to the United Network for Organ Sharing. The average wait for a kidney from a deceased donor is three to five years. People who receive kidneys from living donors also tend to have better outcomes, says Shennen Mao, M.D., Mayo Clinic transplant surgeon.

“People in need of a kidney transplant typically receive a living donor transplant much faster than a deceased donor transplant, avoiding many years of dialysis and its associated complications,” Dr. Mao says. “On average, kidneys from living donors also last longer than those from deceased donors.”

What led to policy change?

Historically, people with diabetes have been prohibited from being living kidney donors because diabetes can cause kidney disease. People with Type 1 diabetes remain ineligible to be a living kidney donor. By expanding eligibility criteria, there’s potential to save more lives through increased kidney availability while maintaining a commitment to the safety and well-being of donors.

What is the policy?

The national policy allows people with Type 2 diabetes to donate a kidney if there is no evidence of organ damage or an unacceptable lifetime risk of complications. Mayo Clinic Transplant Center adopted its own more stringent policies to minimize potential risks for the donor. In addition to national criteria, Mayo Clinic patients with Type 2 diabetes also must meet the following criteria to be a donor:

  • Be age 60 or older.
  • Have well-controlled diabetes and not use insulin.
  • If over age 65, can be using up to two oral medications for diabetes.
  • Not be overweight.
  • Have no family history of kidney disease.
  • Undergo a rigorous health assessment and individualized risk evaluation.

“Mayo Clinic donors undergo thorough health evaluations and risk assessments, ensuring that only those with minimal risk of complications are approved to donate,” says Pooja Budhiraja, M.B.B.S., Mayo Clinic nephrologist. “Criteria such as age limits, weight requirements and the absence of a family history of kidney disease help mitigate the long-term health risks for donors. Our commitment is to safeguard donor health while expanding transplant possibilities.”

Mayo Clinic will also conduct ongoing research to monitor and assess the effect of these policy changes on the long-term outcomes of older living kidney donors with Type 2 diabetes.

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Nocturnal Hypertension Predictor of progression of Diastolic Dysfunction among Diabetes patients Without HF: Study

Diabetes is a significant risk factor for HF (heart failure). It can lead to left ventricular diastolic dysfunction. However, the role of diabetic comorbid conditions, such as nocturnal hypertension, in predicting diastolic dysfunction is unclear without a history of heart failure.

A study in Hypertension aimed to examine how patterns of nocturnal hypertension in individuals with diabetes and without heart failure affect left ventricular diastolic dysfunction. The researchers found that “during the absence of HF periods, nocturnal hypertension is an important predictor for the progression of LV diastolic dysfunction in diabetes patients.”
The study followed 154 diabetes and 268 nondiabetes subjects for 36.8±18.2 months without HF. It investigated the relationship between nocturnal hypertension patterns and LV diastolic dysfunction outcome, defined as an increase in E/e′>14, in patients with and without diabetes.
Key findings from the study are:
· The diabetes status and nocturnal hypertension patterns demonstrated a statistically significant interaction effect on the occurrence of E/e′>14 with a hazard rate.
· Based on Kaplan-Meier analysis results, patients with diabetes with non-dipper and riser had a greater risk for a diastolic dysfunction event.
· Based on results from multivariable Cox proportional hazards, non-dipper and riser patterns were associated with a greater risk of the outcome of LV diastolic dysfunction with a hazard ratio of 4.56 and 3.89, respectively.
· There no similar significant associations were found in patients without diabetes.
Concluding further, they said that during the absence of HF periods, nocturnal hypertension is a significant predictor for the progression of LV diastolic dysfunction in diabetic patients.
Study limitations include limited generalizability, the atrial volume not being evaluated, and E/eʹ’s inability to accurately reflect LV filling pressure in patients with preserved ejection fraction. Nocturnal hypertension assessment was only performed at enrollment.
Reference:
Kidawara Y, Kadoya M, Igeta M, et al. Nocturnal hypertension and left ventricular diastolic dysfunction in patients with diabetes with the absence of heart failure: prospective cohort HSCAA study. Hypertension. Published online November 22, 2023. doi:10.1161/HYPERTENSIONAHA.123.21304

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Psilocybin-assisted therapy may significantly reduce anxiety scores in phase 2 trial

Researchers have found in a phase 2 trial that Psilocybin-assisted therapy may significantly reduce scores in generalized anxiety disorder.

The trial met its primary endpoint, demonstrating a large clinical effect in the psilocybin treatment group over the placebo group.

The trial protocol and treatment design were developed in partnership with the Clinical Psychedelic Lab at Monash University, led by Dr Paul Liknaitzky.

The reduction in HAM-A score from baseline in the psilocybin group was 12.8 points, from 29.5 at baseline to 16.8 at week 11 (6 weeks following the final dosing session), representing a decrease of 9.2 points over the placebo group (-12.8 psilocybin vs. -3.6 placebo; p<0.0001). 44% of patients in the psilocybin group showed a clinically meaningful improvement of at least 50% reduction in anxiety score from baseline; a ‘response rate’ more than four times higher than that of the placebo group. 27% of patients in the psilocybin group achieved full disease remission; a rate more than five times higher than that of psychotherapy with placebo.

Psilocybin within the context of PsiGAD psychotherapy was observed to be well-tolerated, with only mild and moderate adverse events (AEs) reported. The reported AEs were consistent with the known effects of the drug. No serious or severe adverse events were observed. Only one person of the 73 participants withdrew from the trial during the 7-week treatment program.

“We are thrilled with the results from our initial PsiGAD trial,” said President and CEO Joel Latham. “This is the first time psilocybin has been investigated for treatment of generalised anxiety disorder, and the reduction in HAM-A scores we have observed are far greater those reported from trials on established medicines for treatment of anxiety. The improvement in anxiety scores in PsiGAD1 are of a similar magnitude to the change seen in studies investigating psilocybin for treatment of depression disorders. Safety is a key component of any new therapy, and we are delighted that no serious or severe adverse events were observed in PsiGAD patients, which is testament to the focus on safety within the PsiGAD treatment protocol. The safety and efficacy results from PsiGAD1 implore us to continue the development of PsiGAD through large scale well-controlled trials, because this treatment method has the potential to improve the quality of life for millions of people suffering from generalised anxiety disorder.”

Incannex have designed the follow-up Phase 2B clinical trial, PsiGAD2, with the assistance of Clerkenwell Health, a UK based contract research organisation specialising in psychiatry and CNS treatments. This trial will be conducted at multiple sites in the United States (US) and United Kingdom (UK).

In parallel, Incannex has finalised the development of formulation of its psilocybin drug product, PSX-001. Final preparations for the manufacture of the cGMP clinical trial supply of PSX-001 are underway. Documentation on the formulation development and cGMP manufacture will form the final pieces of the FDA IND application that Incannex commenced in August of 2023. Clearance of the IND by the agency is required for the Company to conduct the PsiGAD2 study at sites in the US.

Incannex is continuing to work with Clerkenwell Health to select trial sites and prepare the relevant regulatory documents for submission to the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK.

About Generalised Anxiety Disorder

Generalised Anxiety Disorder (GAD) is characterised by excessive anxiety and worry that occurs more days than not for at least 6 months and is not restricted to any particular environmental circumstances. Symptoms are variable, including feelings of persistent and excessive worry, nervousness, restlessness, difficulty concentrating, and a range of somatic manifestations. People with GAD find it difficult to control their worry, which may cause significant distress and impairment in social, occupational, or other areas of functioning. GAD is a relatively common disorder (about 6-9% lifetime prevalence, and about 3% 12-month prevalence in countries like Australia and the United States). As with other mood disorders, successful treatment of GAD remains inadequate, with less than half of patients achieving remission following evidence-based treatment, alongside high relapse rates, and substantial treatment side-effects or cost.

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