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Associated Press
11-07-2025
- Health
- Associated Press
MIRA Reports Clear Reversal of Anxiety-Related Behavior in Animal Model Using SKNY-1, an Oral Drug Candidate for Obesity and Nicotine Addiction Under Definitive Agreement for Acquisition
SKNY-1 was previously shown to achieve up to 30% weight loss, reverse nicotine craving, and preserve muscle mass in an animal model-and is designed to avoid the CNS side effects that halted earlier CB1-targeting drugs MIAMI, FL / ACCESS Newswire / July 11, 2025 / MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA) today announced new preclinical results from SKNY-1, an oral drug candidate for obesity and nicotine addiction currently under definitive agreement for acquisition. In a validated behavioral model used to measure Cannabinoid 1 receptor (CB1) related anxiety-like effects, SKNY-1 demonstrated clear reversal of anxiety-related behavior induced by a CB1 activator, setting it apart from earlier CB1-targeting drugs that were discontinued due to serious central nervous system (CNS) effects. SKNY-1 is being developed as a potential oral treatment for obesity and addiction. It has previously been shown to achieve up to 30% weight loss, reverse high-calorie food and nicotine cravings, and preserve muscle mass in preclinical models. These new findings suggest that SKNY-1 may deliver these therapeutic effects without emotional or behavioral disruption, an important factor in long-term treatment adherence. 'These findings are a significant step forward,' said Erez Aminov, Chief Executive Officer of MIRA. 'The ability to suppress appetite and cravings while reversing anxiety-like effects is critical. These results reinforce the differentiated approach behind SKNY-1 and its potential role as a novel oral treatment in large, underserved markets.' About the Study The study used the light-dark preference test in zebrafish-a validated behavioral model to assess anxiety-related responses. Zebrafish naturally prefer darker environments due to an innate fear of predators. However, when anxiety levels are elevated, they avoid the light even more strongly spending more time in the dark. Reduced dark preference (i.e., more time in the light) is interpreted as a calming effect. Four groups were evaluated: These results suggest SKNY-1 may help stabilize mood and stress-related behavior-a potential advantage in treating both metabolic and addictive disorders. A New Approach to Endocannabinoid Modulation SKNY-1 targets the endocannabinoid system (ECS)-a key regulator of hunger, emotion, reward, and addictive behavior-through a multi-pathway approach: This multi-target profile gives SKNY-1 a differentiated mechanism that may allow it to reduce cravings and weight while supporting emotional health-without the psychiatric side effects that limited earlier CB1 or MAO-based drugs. 'The ability to block cravings while preserving emotional balance is a key challenge in this field,' said Dr. Itzchak Angel, MIRA's Chief Scientific Advisor. 'SKNY-1 appears to meet that challenge head-on. The demonstration that its profile is significantly different than rimonabant in its interaction with CB1 agonists, reinforces the unique pharmacological profile of the drug.' Market Opportunity Obesity and addiction are among the most urgent and expensive public health challenges globally. In the U.S. alone, the economic burden of obesity and related chronic diseases is estimated at $1.7 trillion annually, equivalent to over 9% of the nation's GDP ( Milken Institute, 2023 ). Yet despite significant commercial investment, current therapies remain limited by efficacy gaps and tolerability challenges. Current GLP‑1 therapies like semaglutide deliver weight loss but are injectables, often cause gastrointestinal side effects, and can result in loss of lean muscle mass. Smoking cessation therapies such as varenicline or bupropion offer modest long-term success and may carry psychiatric warnings that restrict their use in sensitive patient populations. Earlier CB1-targeting drugs, including rimonabant, were withdrawn due to severe mood disorders. Furthermore, broad MAO inhibition-especially MAO‑A-has long been associated with mood instability and dangerous food-drug interactions. SKNY‑1 was developed to address those limitations directly. With oral administration, differentiated pharmacology, and potential dual efficacy in obesity and nicotine addiction, SKNY‑1 may offer a best-in-class profile. Its lack of MAO‑A inhibition, confirmed in vitro, further enhances its therapeutic promise. Next Steps MIRA is currently preparing for shareholder approval related to the proposed acquisition of SKNY Pharmaceuticals, Inc. Pending approval, the Company expects to initiate Investigational New Drug (IND)-enabling studies for SKNY-1 as a next step toward human clinical trials. About MIRA Pharmaceuticals, Inc. MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA) is a clinical-stage pharmaceutical company focused on the development and commercialization of novel therapeutics for neurologic, neuropsychiatric, and metabolic disorders. The Company's pipeline includes oral drug candidates designed to address significant unmet medical needs in areas such as neuropathic pain, inflammatory pain, obesity, addiction, anxiety, and cognitive decline. Cautionary Note Regarding Forward-Looking Statements This press release and the statements of MIRA's management related thereto contain 'forward-looking statements,' which are statements other than historical facts made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These statements may be identified by words such as 'aims,' 'anticipates,' 'believes,' 'could,' 'estimates,' 'expects,' 'forecasts,' 'goal,' 'intends,' 'may,' 'plans,' 'possible,' 'potential,' 'seeks,' 'will,' and variations of these words or similar expressions that are intended to identify forward-looking statements. Any statements in this press release that are not historical facts may be deemed forward-looking. Any forward-looking statements in this press release are based on MIRA's current expectations, estimates, and projections only as of the date of this release and are subject to a number of risks and uncertainties (many of which are beyond MIRA's control) that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements, including related to MIRA's potential merger with SKNY Pharmaceuticals, Inc. These and other risks concerning MIRA's programs and operations are described in additional detail in the Annual Report on Form 10-K for the year ended December 31, 2024, and the Form 14A filed by MIRA on June 18, 2025, and other SEC filings, which are on file with the SEC at and on MIRA's website at MIRA explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law. Contact: Helga Moya [email protected] (786) 432-9792 SOURCE: MIRA Pharmaceuticals press release
Free Malaysia Today
07-06-2025
- Health
- Free Malaysia Today
Segamat MP urges nationwide vape ban
Segamat MP R Yuneswaran said existing control measures at the federal level are 'still weak' compared to state-level measures to stop vaping. PETALING JAYA : Segamat MP R Yuneswaran has urged the government to impose a total ban on the sale and distribution of vape products to safeguard public health and protect the youth from nicotine addiction. Citing 'alarming' data and mounting health concerns, Yuneswaran warned Putrajaya that inaction could lead to long-term health crises and an overwhelmed public healthcare system. Noting an increase in the rate of youth vaping and using e-cigarettes from 9.8% in 2017 to 14.9% in 2022, he said this not only signalled a growing nicotine addiction among the youth but would also bring severe health consequences. He said while several state governments had banned vape sales or were considering it, existing control measures at the federal level were 'still weak'. Yuneswaran also noted that the government had exempted nicotine liquids in vapes from the Poisons Act 1952, allowing the sale of nicotine-containing vape products without regulation. He said this decision had led to a rapid growth in the vape market, making it increasingly difficult to control, especially among the youth. 'Although Parliament recently passed the Control of Smoking Products for Public Health Bill 2023, the 'Generational End Game' (GEG) clause which would have banned the sale of nicotine products to anyone born after 2007 was removed, missing a crucial opportunity to protect young people from addiction. 'Without such key provisions and comprehensive vape regulation, efforts to curb youth nicotine addiction will become more challenging. 'The government is urged not to prioritise short-term tax gains over public well-being. Instead, the future of the next generation must come first. Implement a total vape ban to ensure a healthier Malaysia, free from the dangers of vaping.' He added that vaping was not a safe alternative to smoking, noting 17 cases of vape-related lung injuries (Evali) were reported in 2023, and the country's first local vape-related death reported last June. Yuneswaran also warned of the steep economic consequences of treating Evali, which could cost up to RM150,000. He said by 2030, the government might have to spend RM369 million annually on vape-related treatment. 'This nearly offsets the government's projected vape tax revenue of RM500 million per year, showing that the economic benefits of the vape industry are far outweighed by the health costs borne by the government,' he said. 'The public health sector risks losing hundreds of millions of ringgit to treat vape-related complications – funds that could be better used for other urgent health needs.'
Sky News
31-05-2025
- Health
- Sky News
Kids 'sleep with vapes under pillows' - but will sales ban on disposables have any effect?
As a ban on the sale of disposable vapes comes into force on Sunday, a doctor who set up the first-ever clinic to help children stop vaping has said she has seen patients so addicted they couldn't sleep through the night without them. Professor Rachel Isba established the clinic at Alder Hey Hospital in Liverpool in January and has now seen several patients as young as 11 years old who are nicotine dependent. "Some of the young people vape before they get out of bed. They are sleeping with them under their pillow," she told Sky News. "I'm hearing stories of some children waking up at three o'clock in the morning, thinking they can't sleep, thinking the vape will help them get back to sleep. Whereas, actually, that's the complete opposite of how nicotine works." Ms Isba said most of her patients use disposable vapes, and while some young people may use the chance to give up, others will simply move to refillable devices after the ban. "To me, vaping feels quite a lot like the beginning of smoking. I'm not surprised, but disappointed on behalf of the children that history has repeated itself." A government ban on single-use vapes comes into effect from Sunday, prohibiting the sale of disposable vaping products across the UK, both online and in-store, whether or not they contain nicotine. The Department for Environment, Food and Rural Affairs (Defra) said usage among young vapers remained too high, and the ban would "put an end to their alarming rise in school playgrounds and the avalanche of rubbish flooding the nation's streets". Circular economy minister Mary Creagh said: "For too long, single-use vapes have blighted our streets as litter and hooked our children on nicotine. That ends today. The government calls time on these nasty devices." At nearby Shrewsbury House Youth Club in Everton, a group of 11 and 12-year-old girls said vape addiction is already rife among their friends. Yasmin Dumbell said: "Every day we go out, and at least someone has a vape. I know people who started in year five. It's constantly in their hand." Her friend Una Quayle said metal detectors were installed at her school to try to stop pupils bringing in vapes, and they are having special assemblies about the dangers of the devices. But, she said, students "find ways to get around the scanners though - they hide them in their shorts and go to the bathroom and do it". The girls said the ban on disposables is unlikely to make a difference for their friends who are already addicted. According to Una, they'll "find a way to get nicotine into their system". As well as trying to address the rise in young people vaping, the government hopes banning single-use vapes will reduce some of the environmental impact the devices have. Although all vapes can be recycled, only a tiny proportion are - with around eight million a week ending up in the bin or on the floor. Pulled apart by hand Even those that are recycled have to be pulled apart by hand, as there is currently no way to automate the process. Scott Butler, executive director of Material Focus, a recycling non-profit group, said vapes were "some of the most environmentally wasteful, damaging, dangerous consumer products ever sold". His organisation worries that with new, legal models being designed to almost exactly mimic disposables in look and feel - and being sold for a similar price - people will just keep throwing them away. He said the behaviour "is too ingrained. The general public have been told 'vapes are disposable'. They've even been marketed this way. But they never were disposable".
South China Morning Post
31-05-2025
- General
- South China Morning Post
UK's ban on disposable vapes sparks debate on effectiveness
A ban on disposable vapes goes into effect across the UK on Sunday in a bid to protect children's health and tackle a 'throwaway' culture. 'For too long, single-use vapes have blighted our streets as litter and hooked our children on nicotine,' junior environment minister Mary Creagh said. She said the government was calling 'time on these nasty devices' – a type of e-cigarette which are very popular with young people – and banning sales of single-use vapes or their supply in a crackdown on UK corner shops and supermarkets. Those caught flouting the ban will face a £200 (US$270) fine, while repeat offenders risk up to two years in prison. Young people and children in particular have been attracted to cheap and colourful disposable vapes, which have snazzy flavours such as mint, chocolate, mango or watermelon, since they were introduced in the UK in 2021. A display of disposable vapes in a shop in Liverpool. Photo: AFP In 2024, nearly five million disposable vapes were thrown away each week, according to Material Focus, an independent UK-based non-profit.
BBC News
30-05-2025
- Business
- BBC News
What does Kent and Sussex think of the disposable vape ban?
Disposable vapes are less harmful than smoking cigarettes and have become a multi-million pound industry in the UK, so why is the government to ban them?The single-use vapes are discarded after one usage, with Brits discarding an estimated five million disposable vapes each is also harming the health of young people, often attracted to the sweet flavours and bright packaging, with about 7% (390,000) of 11 to 17-year-olds in the UK using vapes last of the introduction of the ban on Sunday, BBC South East has been finding out more about the reasons behind the law change and what it means for you. When vapes were first commercially available, they were meant to be used as a way for smokers to ditch of 2024, there were 5.6m adults vaping in Great Britain, according to public health charity Action on Smoking Health. But of those, 8% said they had never tried a cigarette before. What is changing? The ban has two objectives, which are to reduce environmental damage and help cut the number of young people addicted to will be no longer be allowed to sell or supply single-use vapes, either in shops or England, those found to have broken the law will receive a £200 fine and face up to two years in prison for repeat offences. The fines differ in Wales, Scotland and Northern vapes will remain largely available, as the government defines a reusable vape as one which can be refilled with liquid and recharged. A vape would be illegal if it cannot do both. How does vaping affect children? There has been an increase in youth vaping in recent years, with a quarter of 11 to 15-year-olds admitting they had tried it, despite it being illegal to sell them to people under 18, according to Minister for Public Health and Prevention, Andrew Jack Jacobs, a GP in Hamstreet, Kent, said vaping was a particular problem for young and developing lungs."The health concerns are all very documented now - it can cause damage to lungs and high doses of nicotine can potentially lead to heart arrhythmia," he said."I think the ban sends a message about the dangers and will help to limit the variety available." Earlier this year, the Welsh government's health minister, Sarah Murphy, said children were starting secondary school already addicted to Murphy said teachers told her that children were leaving lessons "two or three times" to vape, and were struggling to sit through their mock Reed, the UK government's environment secretary, has promised that "rogue traders" who continue to sell disposable vapes to children would face "serious penalties"."Single-use vapes get kids hooked on nicotine and blight our high streets, and we won't stand for this any longer," he added. What about the environment? It is nearly impossible for the plastic used in disposable vapes to completely break the plastic breaks into tiny microplastics, which can enter the food chain and contaminate the retailers that sell vapes must legally take them back once they are empty. But with an average of eight disposed of each second, most end up in landfill. "For the small number of single-use vapes which are sent for recycling, it's a difficult job because they contain many chemical components and are not designed to be taken apart," a government spokesperson said."They usually have to be disassembled by hand – a slow and tricky process which struggles to match the avalanche of vapes that are produced and discarded."In 2022, the Material Focus group found that more than 40 tonnes of lithium in single-use vapes were thrown out – the same amount needed to power 5,000 electric were also 1,200 bin lorry fires in 2023 caused by vapes being incorrectly disposed of. Here's what you had to say A public consultation in February last year found that 69% of people were in favour of the ban – including many who work in the vape employee at a vape shop in Hove, East Sussex, who asked to remain anonymous, told the BBC he and his colleagues were in favour of the ban."You're disposing of a whole battery every time, which is just no good for anyone, so we're all really happy for it," he said."We always try to tell people how much money they would be saving [with a reusable vape] and you always get more control with the nicotine, whereas all the disposables are just the strongest you can get."But some doubted the ban will work as the government hoped, instead pushing the vape trade "underground".Hove resident Brendan Barclay said: "It probably won't be effective. There's so many manufacturers out there that people will just get it by any means necessary, it's the same with drugs."It's just more work for the police to be honest."And some disagree with the ban altogether, with one man calling it "another lack of freedom".
