I'm Begging You To Stop Doing This One Thing When You Get Home From Vacation Because It Might Actually End Your Life
Whether you're walking around Disney World, swimming in the ocean or taking a mountain trip, it's needless to say that many vacations — while tons of fun — can also be tiresome. After packing in as much as possible on your days off, exhaustion may set in as you rush back home to prepare for going back to work or school.
It's important to be aware of a danger that comes with this: drowsy driving. Defined as driving while sleepy, it's more common than you think. According to a Centers for Disease Control survey, about 1 in 25 adult drivers reported falling asleep while driving within the past 30 days.
According to a study by the AAA Foundation for Traffic Safety, 21% of fatal crashes involved a drowsy driver. So, while you may feel like you're in control and can keep yourself awake, remember that probably everyone in that situation also felt the same.
Tiredness can affect your mind and ability to drive in a slew of ways, too, so there's no one way in which an accident will happen. According to Susan Miller, a lead researcher and certified sleep expert at SleepMattressHQ.com, being sleepy can impair your judgment and decision-making, reduce awareness of your surroundings (from cars to road conditions to traffic signals), and affect your coordination, balance and fine motor skills.
'Even a momentary lapse of attention can be dangerous while driving, so prioritizing safety is important,' she added.
Jeff Kahn, a sleep expert and the CEO and co-founder of Rise Science, agreed. 'Microsleeps, in particular, are a cause for alarm, as they can last only a few seconds and occur unknowingly,' he said. 'While this might not seem like much, on a highway traveling at 65 miles per hour, those seconds can mean the difference between life and death.'
Further, the dangers of driving while sleepy are often compared to the dangers of driving drunk. Kahn said 24 hours worth of sleep deprivation — at once, or accumulated over time — results in the same cognitive impairment equivalent as a blood alcohol content (BAC) of 0.10%, which is higher than the legal limit. And again, he added, it's unsafe to drive even before you reach that point.
He pointed to the concept of 'sleep debt,' or not getting enough sleep cumulatively. 'If you regularly miss an hour of sleep for 10 consecutive nights, your cognitive impairment can be as severe as if you hadn't slept for 24 hours straight,' he explained.
When Drowsy Driving Is Most Likely To Occur
One of the two time ranges when this occurs may surprise you. According to the Department of Health of New York State, most sleep-related crashes occur between 1 p.m. and 4 p.m., and 2 a.m. and 6 a.m. So yes, driving in the early morning isn't a great idea, but that 'afternoon slump' period isn't either.
This is when bodies are typically the most tired. 'Importantly, these are the times when you're biologically-inclined to be more drowsy, thanks to the peaks and dips of your circadian rhythm (your internal body clock),' Kahn said. 'Your circadian energy dips will happen regardless if you had enough sleep or not, but sleep deprivation will make you feel drowsier at these times than you otherwise would.'
Unfortunately, many factors can contribute to this, though some may be more common than others. Here are a few of the most common ones:
Not getting enough solid sleep on your vacation
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'One of the biggest contributors to drowsy driving is sleep deprivation,' Miller said. 'This can lead to difficulty concentrating, slower reaction times and even falling asleep at the wheel.'
While the amount of sleep each person needs will vary, most adults need seven to nine hours a night, she added. (BTW, 'junk sleep,' or low-quality sleep, doesn't count.)
A sleep disorder
A bigger sleeping issue may be going on, so checking with a doctor is smart. 'Some disorders, like obstructive sleep apnea, cause low-quality sleep as sleep is often interrupted or restricted, thus low-quality and less restorative,' said Nicole Eichelberger, a sleep expert at Mattressive.
What's even scarier is that it's not always noticeable. 'Unfortunately, most people who suffer from sleep disorders are unaware,' she continued. 'Therefore, it is essential to seek medical help if you notice excessive daytime sleepiness.'
Medications or alcohol
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Miller also listed alcohol and medications, such as antihistamines or benzodiazepines, as contributors to drowsiness and impaired cognitive function. So if you're enjoying a few cocktails by the pool, for example, be cognizant of this.
'Even small amounts of alcohol and certain drugs can cause drowsiness, poor coordination and slower reaction times, making driving dangerous,' she said. To avoid this, Eichelberger urged reading the side effects listed on the medicines you take, and to avoid driving if drowsiness is listed.
When and how long you're driving
The time of day and distance matter, too. Many of us road trip to our vacation destinations and often power through the drive in order to get there or get home.
'Driving overnight (which can be tempting to avoid traffic) increases the risk of experiencing sleepiness, even if you think you are well-rested,' said Holly Milling, a clinical psychologist, behavioral sleep medicine specialist and director of The Sleep Practice. 'Driving for long periods of time, at any time of day, is also tiring, and driving without a break can increase vulnerability to sleepiness.'
Signs You Should Pull Over Immediately
Simply put, you shouldn't drive while sleepy, even if you think you can make yourself stay awake. More specifically, here are some other danger signs these experts listed:
Being unable to remember driving for the last few minutes
Struggling to focus your eyes and concentrate
Drifting into another lane
Head bobbing
Yawning
Feeling easily frustrated
Rubbing your eyes or struggling to keep them open
Following cars too closely
Getting restless or fidgeting
Not keeping a consistent speed
Braking too late
Missing signs and exits
'Even if you don't feel like you'll fall asleep, these signs indicate that your driving ability is impaired and that it's unsafe to continue driving,' Kahn said.
What To Do If You're Tired At The Wheel
As tempting as it sounds, the answer isn't louder music, colder air or talking to someone. 'The only cure for sleepiness is sleep,' Milling said.
While napping in public may feel uncomfortable, it's crucial. You can take a nap at a rest area, gas station or other place you feel safe. And hey, only a short nap is needed.
'Ideally, you should take a 20 to 30 minute nap to feel refreshed, but not so long that you enter a deep sleep cycle and wake up feeling groggy,' Miller said. 'If you're unable to nap, simply resting your eyes or having a break from driving for a few minutes can also be helpful.'
While caffeine can help, Miller continued, it's a short-term fix and it can't cure severe fatigue. She recommends drinking about 200mg of caffeine (equivalent to a cup of coffee) 30 minutes before getting back on the road.
Having a coffee between napping and driving also adds time between waking up and driving, which Kahn said is important. He encourages having that buffer time 'to ensure the post-nap grogginess doesn't affect your driving skills (even if you've only napped for less than 20 minutes).'
Combining the two can eliminate mid-afternoon sleepiness for up to an hour, according to a study in the journal Psychophysiology. But again, these experts say a nap comes first and foremost. 'Whether you include caffeine or not, though, the most important ingredient is the nap,' Milling emphasized. 'Never skip sleep in favor of a double espresso.'
Lastly, while it may seem counterintuitive, some movement (along with the nap) can help. 'A short burst of exercise can wake you up and increase your alertness,' Miller said. She encouraged light stretching or a short walk. You could even get some errands done during this time, like walking around the grocery store.
If these options feel undoable or aren't cutting it, don't let that deter you. 'Call someone to drive you home or the rest of the way,' Eichelberger urged. 'You can also find a motel [and] rest for the night, or get a cab and head home.' While a Lyft ride or motel stay won't be inexpensive, it is cheaper — and safer — than the alternative.
Long-term, Eichelberger recommended maintaining good sleep habits. If you notice excessive fatigue often, she added, consider talking to a sleep doctor so you can avoid car accidents (and various other problems).
Being proactive is always smart, too. Milling mentioned not driving if you've been awake for 18+ hours and scheduling breaks every couple of hours, to start. This way, you're less likely to get caught in a drowsy driving situation.
While vacations and life can keep us busy, sacrificing sleep isn't a great idea — especially if you're ever behind the wheel.This article originally appeared on HuffPost.
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Inflammation Link Allergy, Asthma, and Depression?
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Evolutionary 'Mismatch' One line of inquiry that implicates inflammation in depression, chronic airway trouble, and allergies, involves the microbiome and how modern living has altered it. 'There's essentially an evolutionary mismatch in the modern world,' Charles Raison, MD, professor of psychiatry and human ecology at the University of Wisconsin - Madison, told Medscape Medical News in an interview. 'We've made the world so clean we deprive ourselves — especially in early life when allergies and asthma tend to develop — of contact with microorganisms that train the immune system not to fire off at things they don't need to fire off about.' In a review of literature published in 2013 on immune function titled, Inflammation, Sanitation, and Consternation , Raison and his coauthors concluded that measured exposure to certain microorganisms and their antigens could offer both prevention and intervention for depression. 'Our current challenge is to determine who among those with allergies is at highest risk of developing depression, and why,' Christopher Lowry, PhD, a coauthor on the paper with Raison, told Medscape Medical News . Lowry is a professor of integrative physiology and associate chair of faculty affairs at the University of Colorado Boulder. 'Old Friends' Raison and Lowry's collaboration follows on from the 'Old Friends' work of Graham Rook, a coauthor of their review study, and an emeritus professor of medical microbiology at the University College London in London, England. 'The association between allergies and depression is embedded in the 'Old Friends' or Biodiversity Hypothesis which posits that reduced exposures to diverse microbial environments, which is typical of modern urban lifestyles, increases risk of allergies, anxiety disorders, and depression,' Lowry told Medscape Medical News . Because the commensal microorganisms in the gut are one of the major types of microbial 'Old Friends' that can induce anti-inflammatory and immunoregulatory responses, Lowry said, 'Those who lack diverse microbial exposures, including diverse microbial exposures in the gut microbiome, are thought to be at higher risk of inflammatory disease and inflammation-associated conditions.' Similarly, 'we have shown that this response is greater in persons who grow up in an urban environment, without daily exposure to pets, relative to persons who grow up on a farm, with daily exposure to farm animals,' said Lowry, whose research on the immune effects of exposure to animals was published in the Proceedings of the National Academies of Science . Other categories of microbial 'Old Friends,' according to Lowry, are environmental saprophytes found in soil, mud, and unpurified water, and so-called 'Old Infections' such as the hepatitis A virus or Salmonella . Rook has gone so far as to say that these microbial inputs, 'are absolutely crucial in early life, but continue to be important in adulthood and old age.' Raison added, 'These microbes don't cause illnesses, they are the teachers of tolerance, is how we used to say it. When we began to institute a bunch of modern sanitation and medical practices, on the plus side people stopped dying in youth. Huge win. But we didn't see we were tossing out the good with the bad, and we've lost our exposure to these environmental immunoregulatory organisms that suppress inflammation.' In the past 40 years, incident rates for asthma in the US have doubled according to federal data. A third of persons in the US now have an allergy of some kind, these data also showed. Rates of depression are also at their highest, according to a probability-based Gallup survey of 100,000 adults in the US. In 2023, the survey found that 29% of US adults had been given a diagnosis of depression in their lifetime. Microbial Population Health Initiative The 'Old Friends' theory was tested in Finland for the decade between 2008 and 2018, when a population health initiative to increase exposures to diverse microbial environments led to a reduction in hospitalizations for asthma by half nationally and a 50% drop in the number of food allergies reported in Finnish schools and daycares. The results were published in 2021 in The Journal of Allergy and Clinical Immunology . Depression rates for this time period in Finland are not currently available. 'This was hot, sexy stuff back 20 years ago, but nobody figured out the magic bullet to end all allergies and asthma, so like a lot of things in mental health, it didn't come too much,' Raison said. 'It's gone through fads, like the probiotic fad. But another question would be, what if you were to re-expose kids to these kinds of microbes that train the immune system not to be so agitated, would you lower rates of depression and suicide in adults? Those studies were never done.' Lowry, however, now studies whether the microorganism, Mycobacterium vaccae ATCC 15483, which has been identified as having anti-inflammatory, immunoregulatory, and stress-resilience properties, can be leveraged to protect humans from the effects of inflammation. In a study that was published earlier this year in Brain, Behavior and Immunity , Lowry and his colleagues found M vaccae reduced biomarkers of neuroinflammation and anxiety-like behavior in animals. It also reduced several indicators of obesity such as plasma leptin concentrations and adipose tissue. 'We hope to conduct clinical trials in the next 2-5 years to determine if treatment with mycobacteria can reduce inflammation and promote stress resilience in humans,' Lowry said. 'Future studies should evaluate if mycobacteria or other 'Old Friends' can prevent or treat anxiety and depression.' Inflammation Is Bidirectional If depression in asthma and allergies is at least partially biological, then there are implications for clinical practice, according to one expert. 'The default for physicians is usually that it's hard to have a chronic disease, and that's why their patients are depressed,' Melissa Rosenkranz, PhD, told Medscape Medical News . 'But if they understand that there is a biology that underlies it, that the immune dysregulation that's giving rise to the disease is also contributing to the depression, and that they can do something about that — if we can target those signaling pathways, then we can be treating both simultaneously.' Rosenkranz is an associate professor of psychiatry at the University of Wisconsin - Madison and is the distinguished chair of contemplative neuroscience at the Center for Healthy Minds. Her field is psycho-neuroimmunology, which focuses on interactions between the mind, brain, and immune system. Whether inflammation is the mechanism of action or a symptom in both asthma and depression is something she and her colleagues have studied. 'It goes in both directions,' Rosenkranz said. 'We've done that research.' Alterations in Neural Signaling Their first and second studies involved scanning study patients' brains before and after their airways were challenged with an inflammatory antigen and comparing those results to the before and after scans of the brains of participants exposed to methacholine, which does not irritate, but does constrict, the bronchial passages, making it difficult to breathe. A third study introduced an inflammatory agent to a micro region of the bronchial passages. 'All three studies showed what was happening in the brain was different in the inflammatory context,' Rosenkranz said in the interview. Specifically, Rosenkranz and her colleagues discovered that the brain's salience network — the part that prioritizes which stimuli, both internal and external to the body, require the brain's attention most — responded differently to emotional information when the immune system had been activated. They found that the more the salience network was engaged during psychological stress, the more the inflammatory response in the airway was activated, even without exposure to allergy triggers. 'Our results identify a specific inflammatory pathway linking asthma-related airway inflammation and emotion-related neural function,' Rosenkranz and her coauthors wrote in their study, published in The Journal of Allergy and Clinical Immunology . An immune pathway common to both depression and the airway inflammatory response in asthma is the T helper cell 17 (TH17) response, according to Rosenkranz, whose work has shown that the TH17 response is amplified in the lung during stress. Activity in the TH17 pathway is also elevated in people with depression, according to Rosenkranz, and TH17 is also less responsive to common asthma medications and is associated with treatment-resistant depression. 'There are probably multiple pathways through which [inflammation] happens, so I don't want to claim that this is the only one, but I think it's one among a few that may provoke inflammation in the brain,' Rosenkranz said. 'And inflammation has been shown to be part of the pathophysiology of depression. It's also part of the cascade that gives rise to Alzheimer's disease and other forms of dementia.' Rosenkranz's latest study is on how an asthma exacerbation can lead to inflammation in the brain, and whether those changes might set the stage for dementia. 'It's possible that depression is along the same trajectory as dementia,' Rosenkranz said. 'As you get on later in life, you see the cognitive decline. With nearly 10% of the population having asthma, this is a really important public health question.' Rosenkranz said she doesn't want to be an alarmist. 'I'm not suggesting that everybody who has depression has inflammation in their brain,' she said. As the field searches for an immune-signaling pathway that, if targeted with drugs, could improve asthma, allergies, prevent asthma-related depression, and possibly protect the brain, Rosenkranz said that for now, 'Physicians should evaluate the emotional well-being of their patients and work closely with mental health professionals to address mental and physical symptoms in tandem, so that they can best serve their patients.' They need to understand that depression in patients with asthma or allergy could be a symptom of, not a reaction to their diagnosis, she said.
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Early data suggest Roche's NXT007 may have the potential to provide haemostatic normalisation in people with haemophilia A
Positive phase I/II data presented at the 2025 International Society on Thrombosis and Haemostasis (ISTH) Congress show NXT007 achieved no bleeds requiring treatment in the highest dose groups in people with haemophilia A1 The NXT007 clinical development programme aims to normalise haemostasis and minimise treatment burden2,3 Three phase III clinical studies on NXT007, a next-generation bispecific antibody, set to begin in 20261 Basel, 23 June 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today positive phase I/II data on NXT007 in people with haemophilia A, supporting its progression into phase III clinical development. NXT007 is a next-generation investigational bispecific antibody, engineered by Chugai, a member of the Roche Group. Early data from the NXTAGE study suggest that NXT007 may have the potential to provide haemostatic normalisation in people with haemophilia A (without factor VIII inhibitors). NXT007 showed a tolerable safety profile with no thromboembolic events reported so far.1 These results were featured as an oral presentation at the 2025 International Society on Thrombosis and Haemostasis (ISTH) Congress, 21-25 June, Washington D.C., United States.1 'These NXT007 data are promising for people with haemophilia A and underscore our ongoing commitment to advancing care and addressing the real-world challenges faced by this community,' said Levi Garraway, MD, PhD, Roche's Chief Medical Officer and Head of Global Product Development. 'Hemlibra established a new standard of care, and our focus is to continue to deliver breakthrough innovation that might ultimately help people with haemophilia to live their lives in a manner unaffected by this condition.' NXT007 leverages the Roche Group's expertise in haemophilia A and bispecific antibody development. Our goal is to bring a next generation prophylactic to our portfolio, offering greater therapeutic choice, sustained, elevated bleed protection and reduced treatment burden with factor independence - to allow patients to experience freedom from constant vigilance and have confidence in bleed protection. NXT007 will be further evaluated in a robust clinical development programme, including ongoing phase I/II clinical trials, with additional phase II data expected later this year. There are also three phase III studies currently planned for 2026, including a phase III head-to-head study with Roche's Hemlibra, the first available prophylactic treatment that can be administered subcutaneously and with flexible dosing options (every week, two weeks or four weeks).4,5 Part B of the phase I/II NXTAGE study, conducted by Chugai, in Japan, Taiwan and South Korea, is evaluating the safety, pharmacokinetics, pharmacodynamics and efficacy of prophylaxis with NXT007 in people with haemophilia A without factor VIII inhibitors who had not been previously treated with Hemlibra® (emicizumab).1 Thirty participants (from 12 to 65 years of age) were enrolled in four cohorts (B-1 to B-4) to receive ascending doses of subcutaneous NXT007 every two-to-four weeks during the maintenance period (following four-to-six weeks of loading doses). In presented data from the primary analysis, no treated bleeds were observed with NXT007 in the highest dose cohorts (B-3 and B-4). NXT007 was well tolerated, with no thromboembolic events observed so far.1 About NXT007NXT007 is a next-generation investigational bispecific antibody, being investigated as a prophylactic (preventive) treatment option for people with haemophilia A.1,2,3 NXT007 was engineered by Chugai – a member of the Roche Group – built on Hemlibra® (emicizumab)'s framework, with the aim of optimising factor VIII-mimetic activity and half-life, to further enhance potency, efficacy, dosing and administration convenience. NXT007 brings together factor IXa and factor X, proteins required to activate the natural coagulation cascade.1,2,3 NXT007 is being studied in a robust clinical development programme exploring its potential to achieve sustained elevated bleed protection equivalent to people who do not have haemophilia A (sustained haemostatic normalisation), and reduced treatment burden with factor independence, offering people living with haemophilia A greater therapeutic choice.1,2,3 About haemophilia AHaemophilia A is an inherited, serious disorder in which a person's blood does not clot properly, leading to uncontrolled and often spontaneous bleeding. Haemophilia A affects around 900,000 people worldwide.6,7 People with haemophilia A either lack or do not have enough of a clotting protein called factor VIII. In a healthy person, when a bleed occurs, factor VIII brings together the clotting factors IXa- and X, which is a critical step in the formation of a blood clot to help stop bleeding. Depending on the severity of their symptoms, people with haemophilia A can bleed frequently, especially into their joints or muscles.8 These bleeds can present a significant health concern as they often cause pain and can lead to chronic swelling, deformity, reduced mobility and long-term joint damage.9 A serious complication of treatment is the development of inhibitors to factor VIII replacement therapies. Inhibitors are antibodies developed by the body's immune system that bind to and block the efficacy of replacement factor VIII, making it difficult, if not impossible, to obtain a level of factor VIII sufficient to control bleeding.6 About Roche in haematologyRoche has been developing medicines for people with malignant and non-malignant blood diseases for more than 25 years; our experience and knowledge in this therapeutic area runs deep. Today, we are investing more than ever in our effort to bring innovative treatment options to patients across a wide range of haematologic diseases. Our approved medicines include MabThera®/Rituxan® (rituximab), Gazyva®/Gazyvaro® (obinutuzumab), Polivy® (polatuzumab vedotin), Venclexta®/Venclyxto® (venetoclax) in collaboration with AbbVie, Hemlibra® (emicizumab), PiaSky® (crovalimab), Lunsumio® (mosunetuzumab) and Columvi® (glofitamab). Our pipeline of investigational haematology medicines includes T-cell engaging bispecific antibody cevostamab, targeting both FcRH5 and CD3 and Tecentriq® (atezolizumab). Our scientific expertise, combined with the breadth of our portfolio and pipeline, also provides a unique opportunity to develop combination regimens that aim to improve the lives of patients even further. About Roche Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world's largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalised healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice. For over 125 years, sustainability has been an integral part of Roche's business. As a science-driven company, our greatest contribution to society is developing innovative medicines and diagnostics that help people live healthier lives. Roche is committed to the Science Based Targets initiative and the Sustainable Markets Initiative to achieve net zero by 2045. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit All trademarks used or mentioned in this release are protected by law. References[1] 1. Shima M, et al. NXT007 Prophylaxis in Emicizumab-Naive Persons with Hemophilia A without Inhibitor: Phase I/II Study (NXTAGE) Presented at International Society on Thrombosis and Haemostasis (ISTH) congress; 2025 June. Abstract OC.20.3.[2] Shima M, et al. Safety, Pharmacokinetics, and Pharmacodynamics of Single Subcutaneous Injection of NXT007, an Emicizumab-Based Next-Generation Bispecific Antibody, in Healthy Volunteers (NXTAGE Study). Presented at: International Society on Thrombosis and Haemostasis (ISTH) Congress; 2023 July 28. Abstract OC 69.4. [3] Teranishi-Ikawa Y., et al. A bispecific antibody NXT007 exerts a hemostatic activity in hemophilia A monkeys enough to keep a non-hemophiliac state. Journal of Thrombosis and Haemostasis. 2023; doi: 10.1016/ Hemlibra SmPC [Internet; cited 2025 June] Available from: [5] FDA Prescribing Information [Internet; cited 2025 June]. Available from: [6] Srivastava A, et al. WFH guidelines for the management of hemophilia, 3rd edition. Haemophilia. 2020;26 (Suppl 6): 1-158.[7] Iorio A, et al. Establishing the Prevalence and Prevalence at Birth of Hemophilia in Males. Ann Intern Med. 2019;171(8):540-546.[8] NHS. Symptoms of haemophilia [Internet; cited 2025 June]. Available from: [9] Franchini M, et al. Haemophilia A in the third millennium. Blood Rev. 2013; 179-84. Roche Global Media RelationsPhone: +41 61 688 8888 / e-mail: Hans Trees, PhDPhone: +41 79 407 72 58 Sileia UrechPhone: +41 79 935 81 48 Nathalie AltermattPhone: +41 79 771 05 25 Lorena CorfasPhone: +41 79 568 24 95 Simon GoldsboroughPhone: +44 797 32 72 915 Karsten KleinePhone: +41 79 461 86 83 Nina MählitzPhone: +41 79 327 54 74 Kirti PandeyPhone: +49 172 6367262 Yvette PetillonPhone: +41 79 961 92 50 Dr Rebekka SchnellPhone: +41 79 205 27 03 Roche Investor Relations Dr Bruno EschliPhone: +41 61 68-75284e-mail: Dr Sabine BorngräberPhone: +41 61 68-88027e-mail: Dr Birgit MasjostPhone: +41 61 68-84814e-mail: Investor Relations North America Loren KalmPhone: +1 650 225 3217e-mail: Attachment Media Investor Release phase I_II data on NXT007 EnglishError in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
an hour ago
- Yahoo
Early data suggest Roche's NXT007 may have the potential to provide haemostatic normalisation in people with haemophilia A
Positive phase I/II data presented at the 2025 International Society on Thrombosis and Haemostasis (ISTH) Congress show NXT007 achieved no bleeds requiring treatment in the highest dose groups in people with haemophilia A1 The NXT007 clinical development programme aims to normalise haemostasis and minimise treatment burden2,3 Three phase III clinical studies on NXT007, a next-generation bispecific antibody, set to begin in 20261 Basel, 23 June 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today positive phase I/II data on NXT007 in people with haemophilia A, supporting its progression into phase III clinical development. NXT007 is a next-generation investigational bispecific antibody, engineered by Chugai, a member of the Roche Group. Early data from the NXTAGE study suggest that NXT007 may have the potential to provide haemostatic normalisation in people with haemophilia A (without factor VIII inhibitors). NXT007 showed a tolerable safety profile with no thromboembolic events reported so far.1 These results were featured as an oral presentation at the 2025 International Society on Thrombosis and Haemostasis (ISTH) Congress, 21-25 June, Washington D.C., United States.1 'These NXT007 data are promising for people with haemophilia A and underscore our ongoing commitment to advancing care and addressing the real-world challenges faced by this community,' said Levi Garraway, MD, PhD, Roche's Chief Medical Officer and Head of Global Product Development. 'Hemlibra established a new standard of care, and our focus is to continue to deliver breakthrough innovation that might ultimately help people with haemophilia to live their lives in a manner unaffected by this condition.' NXT007 leverages the Roche Group's expertise in haemophilia A and bispecific antibody development. Our goal is to bring a next generation prophylactic to our portfolio, offering greater therapeutic choice, sustained, elevated bleed protection and reduced treatment burden with factor independence - to allow patients to experience freedom from constant vigilance and have confidence in bleed protection. NXT007 will be further evaluated in a robust clinical development programme, including ongoing phase I/II clinical trials, with additional phase II data expected later this year. There are also three phase III studies currently planned for 2026, including a phase III head-to-head study with Roche's Hemlibra, the first available prophylactic treatment that can be administered subcutaneously and with flexible dosing options (every week, two weeks or four weeks).4,5 Part B of the phase I/II NXTAGE study, conducted by Chugai, in Japan, Taiwan and South Korea, is evaluating the safety, pharmacokinetics, pharmacodynamics and efficacy of prophylaxis with NXT007 in people with haemophilia A without factor VIII inhibitors who had not been previously treated with Hemlibra® (emicizumab).1 Thirty participants (from 12 to 65 years of age) were enrolled in four cohorts (B-1 to B-4) to receive ascending doses of subcutaneous NXT007 every two-to-four weeks during the maintenance period (following four-to-six weeks of loading doses). In presented data from the primary analysis, no treated bleeds were observed with NXT007 in the highest dose cohorts (B-3 and B-4). NXT007 was well tolerated, with no thromboembolic events observed so far.1 About NXT007NXT007 is a next-generation investigational bispecific antibody, being investigated as a prophylactic (preventive) treatment option for people with haemophilia A.1,2,3 NXT007 was engineered by Chugai – a member of the Roche Group – built on Hemlibra® (emicizumab)'s framework, with the aim of optimising factor VIII-mimetic activity and half-life, to further enhance potency, efficacy, dosing and administration convenience. NXT007 brings together factor IXa and factor X, proteins required to activate the natural coagulation cascade.1,2,3 NXT007 is being studied in a robust clinical development programme exploring its potential to achieve sustained elevated bleed protection equivalent to people who do not have haemophilia A (sustained haemostatic normalisation), and reduced treatment burden with factor independence, offering people living with haemophilia A greater therapeutic choice.1,2,3 About haemophilia AHaemophilia A is an inherited, serious disorder in which a person's blood does not clot properly, leading to uncontrolled and often spontaneous bleeding. Haemophilia A affects around 900,000 people worldwide.6,7 People with haemophilia A either lack or do not have enough of a clotting protein called factor VIII. In a healthy person, when a bleed occurs, factor VIII brings together the clotting factors IXa- and X, which is a critical step in the formation of a blood clot to help stop bleeding. Depending on the severity of their symptoms, people with haemophilia A can bleed frequently, especially into their joints or muscles.8 These bleeds can present a significant health concern as they often cause pain and can lead to chronic swelling, deformity, reduced mobility and long-term joint damage.9 A serious complication of treatment is the development of inhibitors to factor VIII replacement therapies. Inhibitors are antibodies developed by the body's immune system that bind to and block the efficacy of replacement factor VIII, making it difficult, if not impossible, to obtain a level of factor VIII sufficient to control bleeding.6 About Roche in haematologyRoche has been developing medicines for people with malignant and non-malignant blood diseases for more than 25 years; our experience and knowledge in this therapeutic area runs deep. Today, we are investing more than ever in our effort to bring innovative treatment options to patients across a wide range of haematologic diseases. Our approved medicines include MabThera®/Rituxan® (rituximab), Gazyva®/Gazyvaro® (obinutuzumab), Polivy® (polatuzumab vedotin), Venclexta®/Venclyxto® (venetoclax) in collaboration with AbbVie, Hemlibra® (emicizumab), PiaSky® (crovalimab), Lunsumio® (mosunetuzumab) and Columvi® (glofitamab). Our pipeline of investigational haematology medicines includes T-cell engaging bispecific antibody cevostamab, targeting both FcRH5 and CD3 and Tecentriq® (atezolizumab). Our scientific expertise, combined with the breadth of our portfolio and pipeline, also provides a unique opportunity to develop combination regimens that aim to improve the lives of patients even further. About Roche Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world's largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalised healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice. For over 125 years, sustainability has been an integral part of Roche's business. As a science-driven company, our greatest contribution to society is developing innovative medicines and diagnostics that help people live healthier lives. Roche is committed to the Science Based Targets initiative and the Sustainable Markets Initiative to achieve net zero by 2045. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit All trademarks used or mentioned in this release are protected by law. References[1] 1. Shima M, et al. NXT007 Prophylaxis in Emicizumab-Naive Persons with Hemophilia A without Inhibitor: Phase I/II Study (NXTAGE) Presented at International Society on Thrombosis and Haemostasis (ISTH) congress; 2025 June. Abstract OC.20.3.[2] Shima M, et al. Safety, Pharmacokinetics, and Pharmacodynamics of Single Subcutaneous Injection of NXT007, an Emicizumab-Based Next-Generation Bispecific Antibody, in Healthy Volunteers (NXTAGE Study). Presented at: International Society on Thrombosis and Haemostasis (ISTH) Congress; 2023 July 28. Abstract OC 69.4. [3] Teranishi-Ikawa Y., et al. A bispecific antibody NXT007 exerts a hemostatic activity in hemophilia A monkeys enough to keep a non-hemophiliac state. Journal of Thrombosis and Haemostasis. 2023; doi: 10.1016/ Hemlibra SmPC [Internet; cited 2025 June] Available from: [5] FDA Prescribing Information [Internet; cited 2025 June]. Available from: [6] Srivastava A, et al. WFH guidelines for the management of hemophilia, 3rd edition. Haemophilia. 2020;26 (Suppl 6): 1-158.[7] Iorio A, et al. Establishing the Prevalence and Prevalence at Birth of Hemophilia in Males. Ann Intern Med. 2019;171(8):540-546.[8] NHS. Symptoms of haemophilia [Internet; cited 2025 June]. Available from: [9] Franchini M, et al. Haemophilia A in the third millennium. Blood Rev. 2013; 179-84. 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