Latest news with #GLP-1s
Business Journals
2 days ago
- Health
- Business Journals
The GLP-1 weight loss debate: Pharmacy benefit leaders weigh in on difficult coverage decisions
Employers are grappling with the ripple effect of an increasingly popular weight loss treatment. Glucagon-like peptide 1 (GLP-1) receptor agonists are a favored treatment for type-2 diabetes but have also become incredibly popular for treating obesity. One in eight U.S. adults have taken GLP-1 medication, according to a KFF Health Tracking Poll, with one in three saying they've heard a lot about them. Usage is growing so fast Goldman Sachs estimates the drugs could push the global market for anti-obesity medications to $100 billion in annual sales by 2030. The challenge for employers is the cost. According to the National Conference of State Legislatures, GLP-1s have an average annual list price of $12,000. Because patients tend to regain weight when they discontinue treatment, the cost of coverage is high. 'GLP-1s are a topic that comes up in almost every client meeting,' said Shanda Harclerode, a pharmacist and pharmacy consultant for Holmes Murphy's employee benefits group. 'Across the board, we're seeing it in the top three drugs in terms of plan spend.' Among Holmes Murphy's employee benefits clients, spending on GLP-1s increased 36% from 2023 to 2024, Harclerode said. The treatments represented 17% of all pharmaceutical spending in 2024 and 4% of medical and pharmacy spending combined. Understanding the market for obesity treatments The appeal for an injectable treatment for obesity is easy to understand, said Nathan Cassin, employee benefits pharmacy director with Holmes Murphy. 'Obesity affects 42% of American adults and that number is rising and these drugs are revolutionary in terms of managing weight,' Cassin said. You have to go back several decades to find new medication releases with this wide of an impact, Cassin said, pointing to Zoloft's approval for mental health conditions in 1991, Lipitor's approval for lowering cholesterol in 1996 and Nexium's approval for reducing stomach acid in 2001. The broad market for obesity treatments has helped spur interest in GLP-1s from many drug manufacturers. There is a robust pipeline of GLP-1 products undergoing clinical trials for obesity treatment and manufacturers are starting to sell the drugs directly to members through telehealth appointments. However, Harclerode said this increased competition will not reduce employers' expenses anytime soon. 'While we may see some of the pricing of the drugs come down as competition increases with new agents coming to market and more competition between the different manufacturers to get their products on the formulary,' she said, 'anticipated increases in utilization are likely going to offset any pricing relief. GLP-1s and similar molecules are currently being studied for a variety of other applications, including Alzheimer's disease, osteoarthritis, and heart failure, significantly expanding their potential use going forward.' Employee benefit strategies for employers Employers are left with difficult choices. Harclerode recommends business leaders start by assessing how GLP-1s fit the needs of their employees. Ask these questions: What is the prevalence of obesity and related conditions within my population? What can we expect in terms of utilization? How much would that utilization cost? Does that cost fit within our employee benefits budget? What is my employee turnover rate? Given that, will our plan realize the potential future benefits that come with weight loss? How important is offering this coverage to our talent attraction and retention efforts? Employers that decide to offer GLP-1 coverage should make sure to design their program in a way that maximizes its effectiveness, Harclerode said. Some clients require people to participate in wellness programs — such as working with a health coach or dietitian — to be eligible for GLP-1 therapies. 'Since these drugs require long-term use for sustained benefits, we want to ensure that if a member stops their GLP-1 therapy, the appropriate behavioral changes have been adopted to maintain the weight loss that was achieved while on the medication,' she said. Because of their popularity, businesses that opt not to cover GLP-1s may want to be transparent with employees about why and what they're doing to support weight loss instead, Harclerode said. They won't be alone. In a 2024 Business Group on Health survey, 67% of large employers reported covering GLP-1s, while only 28% of Holmes Murphy's clients — including many businesses with less than 10,000 people — provide the coverage. 'I don't think there's a one-size-fits-all approach,' Harclerode said. Are you getting the most out of your employer-sponsored pharmacy benefits? From pricing terms and contracts to understanding clinical programs, Holmes Murphy can help. As one of the largest independent insurance brokerages in the nation, Holmes Murphy believes fully in serving the unique risk and benefits challenges of clients in every industry and of almost every size. For more information, visit or follow the company on X (@holmesmurphyins), Facebook, LinkedIn, or Instagram.
Indianapolis Star
2 days ago
- Health
- Indianapolis Star
MIRA Reports Up to 30% Weight Loss and Reversal of High-Calorie and Nicotine Cravings in an Animal Model of Obesity and Craving Using SKNY-1, a Drug Candidate Under Definitive Agreement for Acquisition
Oral therapy designed to minimize CNS side effects shows dual activity in weight loss and smoking cessation models without muscle loss MIAMI, FLORIDA / ACCESS Newswire MIRA (NASDAQ:MIRA) today announced new animal study results from SKNY-1, a next-generation oral therapeutic under definitive agreement for acquisition. In a zebrafish model that mimics human obesity and craving behaviors, SKNY-1 demonstrated weight loss, suppression of appetite and craving for high-calorie diets, and reversal of nicotine-seeking behavior-all achieved within six days of oral treatment. SKNY-1 is being developed as an oral alternative to GLP-1 injectables, which are often limited by nausea, GI discomfort, injection reaction, and growing concerns around muscle loss. Unlike GLP-1s, which reduce both fat and lean mass, SKNY-1 demonstrated significant weight loss with preserved muscle. It was specifically designed to minimize engagement with central nervous system pathways implicated in the psychiatric side effects observed in some smoking cessation therapies and first-generation CB1-targeting weight-loss drugs. The data support SKNY-1's potential as a differentiated oral therapy addressing two of the world's leading causes of preventable death. The study was conducted in an obesity and craving model in Ob42 Strain-mc4r (G894C) mutated zebrafish following six days of oral treatment with two doses of SKNY-1 and was compared to normal controls. Key Results Weight Loss and Muscle Preservation: SKNY-1 reduced body weight by approximately 30% after just six days of oral treatment. Treated animals ended up weighing about 10% less than healthy controls. Importantly, this weight loss was not accompanied by muscle density changes-suggesting SKNY-1 helps burn fat while preserving lean body mass. Metabolic Activity and Ventilation Rate: Treated animals showed an increase in breathing rate, which is a reliable signal that their metabolism was speeding up. This aligns with the observed weight loss and suggests that SKNY-1 helps the body burn more energy. Liver and Lipid Profile Improvements: In untreated obese animals, fat buildup in the liver was about 50% higher than normal. SKNY-1 reversed this buildup, bringing liver fat back to healthy levels. At the same time, cholesterol levels-including LDL ('bad' cholesterol) and HDL ('good' cholesterol)-also returned to normal, without affecting fat levels in the blood. This points to improved fat processing without disrupting the body's overall metabolic balance. Appetite, Craving, and Compulsive Eating: Obese animals were eating 2-3 times more high-calorie food than normal. SKNY-1 dose-dependently reduced this behavior-high-dose animals ate less than healthy controls. The drug also made the animals less likely to pursue food in stressful environments and reduced obsessive food-seeking in tests designed to measure craving. Nicotine Craving and Compulsivity: SKNY-1 significantly reduced the desire to seek out and consume nicotine. Treated animals were less willing to pursue nicotine even in stressful conditions, and they no longer showed a preference for environments linked to nicotine rewards. At the high dose, their behavior matched that of healthy animals with no nicotine craving. Neurohormonal Balance: Obese animals had extremely high levels of leptin (a hunger-regulating hormone) and unusually low levels of ghrelin (the 'hunger signal'). This imbalance often leads to constant hunger and poor appetite control. SKNY-1 normalized both hormones, improving the body's ability to regulate hunger and energy use. Brain Dopamine Regulation: Obese animals had too much dopamine in the brain, likely tied to increased reward and cravings. SKNY-1 reduced these dopamine levels-but only at the lower dose. The high dose did not affect dopamine, suggesting the drug can reduce craving without overstimulating the brain. 'Within just six days, we saw robust behavioral, hormonal and metabolic changes, including weight loss, improved fat metabolism, and reversal of craving-like behaviors,' said Dr. Itzchak Angel, Chief Scientific Advisor at MIRA. 'These results highlight SKNY-1's potential to address both obesity and nicotine addiction through unique and safe pathways.' A Differentiated Approach to Two Major Markets Current weight-loss therapies like semaglutide and tirzepatide are effective but limited by gastrointestinal side effects, injectable administration, and loss of lean mass. Smoking cessation treatments such as varenicline and bupropion carry psychiatric warnings and offer modest long-term quit rates. SKNY-1 was designed to overcome these limitations. It selectively modulates CB1 receptors by blocking β-arrestin signaling-associated with cravings and compulsive behavior-while preserving G-protein signaling, which supports emotional and cognitive stability. The compound also activates CB2 receptors and mildly inhibits MAO-B without affecting MAO-A, supporting a favorable safety and tolerability profile. 'These results position SKNY-1 as a potentially disruptive oral treatment,' said Erez Aminov, CEO of MIRA. 'Its ability to reduce body mass, suppress cravings, and preserve muscle-all through oral administration-makes it a compelling therapeutic candidate as we move toward closing the acquisition and preparing for IND-enabling studies.' The Company believes these findings further support the advancement of SKNY-1 toward Investigational New Drug (IND)-enabling studies. With obesity and smoking representing two of the leading causes of preventable death-and a combined global market opportunity exceeding $200 billion-MIRA intends to prioritize SKNY-1 as a potential cornerstone asset pending completion of the acquisition of SKNY Pharmaceuticals, Inc. 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 anxiety, cognitive decline, neuropathic pain, obesity, and addiction. 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. SOURCE: MIRA Pharmaceuticals View the original press release on ACCESS Newswire
Miami Herald
2 days ago
- Health
- Miami Herald
MIRA Reports Up to 30% Weight Loss and Reversal of High-Calorie and Nicotine Cravings in an Animal Model of Obesity and Craving Using SKNY-1, a Drug Candidate Under Definitive Agreement for Acquisition
Oral therapy designed to minimize CNS side effects shows dual activity in weight loss and smoking cessation models without muscle loss MIAMI, FLORIDA / ACCESS Newswire / June 30, 2025 / MIRA (NASDAQ:MIRA) today announced new animal study results from SKNY-1, a next-generation oral therapeutic under definitive agreement for acquisition. In a zebrafish model that mimics human obesity and craving behaviors, SKNY-1 demonstrated weight loss, suppression of appetite and craving for high-calorie diets, and reversal of nicotine-seeking behavior-all achieved within six days of oral treatment. SKNY-1 is being developed as an oral alternative to GLP-1 injectables, which are often limited by nausea, GI discomfort, injection reaction, and growing concerns around muscle loss. Unlike GLP-1s, which reduce both fat and lean mass, SKNY-1 demonstrated significant weight loss with preserved muscle. It was specifically designed to minimize engagement with central nervous system pathways implicated in the psychiatric side effects observed in some smoking cessation therapies and first-generation CB1-targeting weight-loss drugs. The data support SKNY-1's potential as a differentiated oral therapy addressing two of the world's leading causes of preventable death. The study was conducted in an obesity and craving model in Ob42 Strain-mc4r (G894C) mutated zebrafish following six days of oral treatment with two doses of SKNY-1 and was compared to normal controls. Key Results Weight Loss and Muscle Preservation:SKNY-1 reduced body weight by approximately 30% after just six days of oral treatment. Treated animals ended up weighing about 10% less than healthy controls. Importantly, this weight loss was not accompanied by muscle density changes-suggesting SKNY-1 helps burn fat while preserving lean body mass. Metabolic Activity and Ventilation Rate:Treated animals showed an increase in breathing rate, which is a reliable signal that their metabolism was speeding up. This aligns with the observed weight loss and suggests that SKNY-1 helps the body burn more energy. Liver and Lipid Profile Improvements:In untreated obese animals, fat buildup in the liver was about 50% higher than normal. SKNY-1 reversed this buildup, bringing liver fat back to healthy levels. At the same time, cholesterol levels-including LDL ('bad' cholesterol) and HDL ('good' cholesterol)-also returned to normal, without affecting fat levels in the blood. This points to improved fat processing without disrupting the body's overall metabolic balance. Appetite, Craving, and Compulsive Eating:Obese animals were eating 2-3 times more high-calorie food than normal. SKNY-1 dose-dependently reduced this behavior-high-dose animals ate less than healthy controls. The drug also made the animals less likely to pursue food in stressful environments and reduced obsessive food-seeking in tests designed to measure craving. Nicotine Craving and Compulsivity:SKNY-1 significantly reduced the desire to seek out and consume nicotine. Treated animals were less willing to pursue nicotine even in stressful conditions, and they no longer showed a preference for environments linked to nicotine rewards. At the high dose, their behavior matched that of healthy animals with no nicotine craving. Neurohormonal Balance:Obese animals had extremely high levels of leptin (a hunger-regulating hormone) and unusually low levels of ghrelin (the 'hunger signal'). This imbalance often leads to constant hunger and poor appetite control. SKNY-1 normalized both hormones, improving the body's ability to regulate hunger and energy use. Brain Dopamine Regulation:Obese animals had too much dopamine in the brain, likely tied to increased reward and cravings. SKNY-1 reduced these dopamine levels-but only at the lower dose. The high dose did not affect dopamine, suggesting the drug can reduce craving without overstimulating the brain. "Within just six days, we saw robust behavioral, hormonal and metabolic changes, including weight loss, improved fat metabolism, and reversal of craving-like behaviors," said Dr. Itzchak Angel, Chief Scientific Advisor at MIRA. "These results highlight SKNY-1's potential to address both obesity and nicotine addiction through unique and safe pathways." A Differentiated Approach to Two Major Markets Current weight-loss therapies like semaglutide and tirzepatide are effective but limited by gastrointestinal side effects, injectable administration, and loss of lean mass. Smoking cessation treatments such as varenicline and bupropion carry psychiatric warnings and offer modest long-term quit rates. SKNY-1 was designed to overcome these limitations. It selectively modulates CB1 receptors by blocking β-arrestin signaling-associated with cravings and compulsive behavior-while preserving G-protein signaling, which supports emotional and cognitive stability. The compound also activates CB2 receptors and mildly inhibits MAO-B without affecting MAO-A, supporting a favorable safety and tolerability profile. "These results position SKNY-1 as a potentially disruptive oral treatment," said Erez Aminov, CEO of MIRA. "Its ability to reduce body mass, suppress cravings, and preserve muscle-all through oral administration-makes it a compelling therapeutic candidate as we move toward closing the acquisition and preparing for IND-enabling studies." The Company believes these findings further support the advancement of SKNY-1 toward Investigational New Drug (IND)-enabling studies. With obesity and smoking representing two of the leading causes of preventable death-and a combined global market opportunity exceeding $200 billion-MIRA intends to prioritize SKNY-1 as a potential cornerstone asset pending completion of the acquisition of SKNY Pharmaceuticals, Inc. 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 anxiety, cognitive decline, neuropathic pain, obesity, and addiction. 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 Moyainfo@ 432-9792 SOURCE: MIRA Pharmaceuticals
New York Post
6 days ago
- Health
- New York Post
Ozempic without the side effects? New drug touted as weight loss game changer
There's no doubt that GLP-1 drugs like Ozempic have been revolutionary — not just for people who want to lower their blood sugar and lose weight but for those who want to control other cravings as well. Unfortunately, sometimes these benefits come with unsightly downsides such as tooth decay, a droopy face or mouth, a saggy butt and hair loss. While many of those side effects are due to rapid weight loss — rather than the drugs themselves — the medications are known to cause icky gastrointestinal issues. People on drugs like Ozempic have complained about some unpleasant side effects, including tooth decay, a droopy face or mouth, a saggy butt and hair loss. K KStock – Now, a groundbreaking new drug has shown some of the same promise in melting belly fat — without making your stomach churn. This week in the journal Cell, researchers unveiled a drug — developed by the Sweden biotechnology company Atrogi AB — based on a type of special molecule. While GLP-1s mimic the GLP-1 hormone the body naturally produces after eating to suppress appetite, this new drug activates metabolism in skeletal muscle. In a Phase I clinical trial involving 25 people with Type 2 diabetes and 48 healthy humans, the drug was successful at improving blood sugar levels and weight — without those pesky GLP-1 side effects. Since most GLP-1s are injectables, the fact that this medication comes in tablet form could be groundbreaking to trypanophobes. Since most GLP-1s are injectables, the fact that this medication comes in tablet form could also be groundbreaking to anyone who is afraid of needles. í¢í°í½í íÅí¸í°í¸íâíÅ½í° – 'This drug represents a completely new type of treatment and has the potential to be of great importance for patients with Type 2 diabetes and obesity,' Shane C. Wright, assistant professor at the Department of Physiology and Pharmacology at Karolinska Institutet in Stockholm, said in a statement. 'Our substance appears to promote healthy weight loss and, in addition, patients do not have to take injections.' Wright noted that the drug can be used 'as a stand-alone treatment and in combination with GLP-1 drugs.' This can be a game changer for people who are micro-dosing drugs like Ozempic due to the sky-high costs. It could also be impactful now that the Food and Drug Administration has cracked down on Ozempic copycats, potentially slimming options for consumers who have come to rely on budget-friendly alternatives. Finally, researchers say the drug can boost weight loss without negatively influencing muscle mass or overworking the heart — both crucial longevity markers. 'Our results point to a future where we can improve metabolic health without losing muscle mass,' said Tore Bengtsson, a professor at the Department of Molecular Bioscience at Wenner-Gren Institute in Stockholm. 'Muscles are important in both Type 2 diabetes and obesity, and muscle mass is also directly correlated with life expectancy.'
Yahoo
25-06-2025
- Business
- Yahoo
Jim Cramer on Keurig Dr Pepper: 'I Don't Want to Touch That One'
Keurig Dr Pepper Inc. (NASDAQ:KDP) is one of the 12 stocks on Jim Cramer's radar recently. A caller asked if the company would be able to compete with Coca-Cola long term despite its 'high debt'. In response, Cramer said: 'Yeah, no, I don't want to touch that one. I think if you want to be in that space, you want to be in Coca-Cola. I think Coca-Cola has demonstrated, first of all, I don't want to be in that space because there's just… the Secretary of Health and Human Services is against it. The GLP-1s, the new one from Amgen, just makes it tougher and tougher. You don't want to be in the space…' A conveyor belt filled with assorted K-Cup pods, ready for packaging. Keurig Dr Pepper (NASDAQ:KDP) produces and distributes a wide range of beverages and single-serve brewing systems, including branded concentrates, ready-to-drink products, and coffee-related goods. Oakmark Select Fund stated the following regarding Keurig Dr Pepper Inc. (NASDAQ:KDP) in its Q4 2024 investor letter: 'Keurig Dr Pepper Inc. (NASDAQ:KDP) is one of North America's leading beverage companies, with dominant positions in single-serve coffee and flavored soft drinks. The soft drink portfolio has an impressive track record of volume growth and market share gains. We believe this performance can continue due to favorable demographic trends, brand strength, and distribution advantages. Recently, weakness in the Keurig coffee division caused the stock price to come under pressure. However, we believe these industry-wide challenges will prove transitory because coffee remains a popular beverage. Keurig's coffee division is poised to capitalize on this demand with the largest installed base of single-serve brewers and ample runway to increase household penetration. At the current quote, the market ascribes minimal value to Keurig. We were happy to purchase shares in this above-average business at a discount to the market multiple, other beverage peers and private market transactions.' While we acknowledge the potential of KDP as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the best short-term AI stock. READ NEXT: The Best and Worst Dow Stocks for the Next 12 Months and 10 Unstoppable Stocks That Could Double Your Money. Disclosure: None. Error 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
