Fundraiser in support of Huntington's Disease happening at Oak Mountain
All proceeds from this event will go toward improving the lives of those affected with Huntington's Disease and their families.
Huntington's Disease is a genetic disorder that causes the nerve cells in the brain to breakdown. Around 41,000 Americans are affected, while a further 200,000 are at risk. The children of those that suffer from Huntington's have a 50/50 chance of developing Huntington's. There is no cure.
For registration and more information, click here.
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Business Wire
7 hours ago
- Business Wire
Amylyx Pharmaceuticals Presents New Exploratory Analyses from Phase 2 and Phase 2b Clinical Trials of Avexitide in Post-Bariatric Hypoglycemia at ENDO 2025
CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Amylyx Pharmaceuticals, Inc. (NASDAQ: AMLX) ('Amylyx' or the 'Company') today announced the presentation of new exploratory analyses from the Phase 2 PREVENT and Phase 2b clinical trials of avexitide, an investigational, first-in-class glucagon-like peptide-1 (GLP-1) receptor antagonist for the treatment of post-bariatric hypoglycemia (PBH) at the Endocrine Society's annual meeting (ENDO 2025). In the Phase 2b trial, avexitide 90 mg once daily, the dose being evaluated in the pivotal Phase 3 LUCIDITY trial, led to a 64% least-squares (LS) mean reduction (p=0.0031) vs. baseline in the composite rate of Level 2 and Level 3 hypoglycemic events in PBH, with more than half of the participants experiencing no events during the treatment period. LUCIDITY is a multicenter, randomized, double-blind, placebo-controlled Phase 3 clinical trial evaluating the efficacy and safety of avexitide in approximately 75 participants with PBH following Roux-en-Y gastric bypass surgery. The FDA-agreed-upon primary endpoint of LUCIDITY is reduction in the composite of Level 2 and Level 3 hypoglycemic events. Consistent reductions in composite rate of Level 2 and Level 3 hypoglycemic events also were seen with avexitide 45 mg twice daily studied in the Phase 2b trial and avexitide 30 mg twice daily and 60 mg once daily studied in the Phase 2 PREVENT trial. New pharmacokinetic (PK) and pharmacodynamic (PD) data were also presented demonstrating continuous pharmacologic activity of the 90 mg once daily dose regimen for a 24-hour period. 'Post-bariatric hypoglycemia can profoundly disrupt daily life, requiring individuals to carefully manage meals, social interactions, and routines, often while living in fear of their next hypoglycemic event. The new analysis presented at ENDO 2025 continues to support that avexitide may significantly reduce the frequency of these events,' said Marilyn Tan, MD, FACE, Principal Investigator of the LUCIDITY trial and Clinical Associate Professor at Stanford University. Camille L. Bedrosian, MD, Chief Medical Officer of Amylyx, added, 'Post-bariatric hypoglycemia is a serious and underrecognized condition with no FDA-approved treatments. The data presented show that, in an exploratory analysis from the Phase 2 PREVENT and Phase 2b clinical trials, avexitide significantly reduced the composite rate of Level 2 and 3 hypoglycemic events, including at the 90 mg once daily dose that is being studied in our pivotal Phase 3 LUCIDITY trial. We are particularly encouraged that over half of participants did not experience Level 2 or Level 3 hypoglycemic events during the treatment period. In addition, the pharmacokinetic and pharmacodynamic data demonstrated continuous pharmacologic activity of avexitide 90 mg once daily dose over 24 hours. We continue to be encouraged by avexitide's potential to deliver consistent, meaningful benefit to people living with PBH.' The population PK and PD analyses presented at ENDO 2025 demonstrated that avexitide 90 mg once daily maintained consistent GLP-1 receptor inhibition from morning to midnight and between doses. In vitro potency studies showed an IC₅₀ of approximately 20-30 nM (70-100 ng/mL), indicating robust target inhibition even in the presence of significant levels of GLP-1. PK modeling demonstrated that avexitide plasma levels exceeded IC₅₀ for a full 24-hour period. LUCIDITY was informed by data from five PBH clinical trials of avexitide showing consistent, dose-dependent effects, including statistically significant and clinically meaningful reductions in hypoglycemic events. Avexitide was generally well-tolerated, with a favorable safety profile replicated across clinical trials. Completion of recruitment for LUCIDITY is expected in 2025, with a data readout anticipated in the first half of 2026 and, if approved, commercial launch anticipated in 2027. The presentation and posters are available on the ' Presentations ' tab of the Amylyx website. Webcast Information Amylyx will host an investor event today, July 13, 2025, at 6:00 p.m. PT / 9:00 p.m. ET in San Francisco to discuss post-bariatric hypoglycemia and avexitide. A live webcast of the presentation and Q&A portion of the event can be accessed under 'Events and Presentations' in the Investor section of the Company's website, The webcast will be archived and available for replay for 90 days following the event. About Avexitide Avexitide is an investigational, first-in-class glucagon-like peptide-1 (GLP-1) receptor antagonist that has been evaluated in five Phase 1 and Phase 2 clinical trials for post-bariatric hypoglycemia (PBH) and has also been studied in congenital hyperinsulinism (HI). The U.S. Food and Drug Administration (FDA) has granted avexitide Breakthrough Therapy Designation for both indications, Rare Pediatric Disease Designation in congenital HI, and Orphan Drug Designation for the treatment of hyperinsulinemic hypoglycemia (which includes PBH and congenital HI). Avexitide is designed to bind to the GLP-1 receptor on pancreatic islet beta cells and inhibit the effect of GLP-1 to mitigate hypoglycemia by decreasing insulin secretion and stabilizing blood glucose levels. In PBH, excessive GLP-1 can lead to the hypersecretion of insulin and subsequent debilitating hypoglycemic events. In two Phase 2 PBH clinical trials, avexitide demonstrated highly statistically significant reductions in hypoglycemic events. These events can lead to autonomic and neuroglycopenic symptoms that can have a devastating impact on daily living. About Post-Bariatric Hypoglycemia (PBH) Post-bariatric hypoglycemia (PBH) is a condition that is estimated to affect approximately 8% of people in the U.S. who have undergone the two most common types of bariatric surgery, sleeve gastrectomy and Roux-en-Y gastric bypass (approximately 160,000 people in the U.S.). PBH is thought to be caused by an excessive glucagon-like peptide-1 (GLP-1) response leading to hypoglycemia and impaired quality of life. PBH can cause debilitating hypoglycemic events associated with inadequate supply of glucose to the brain, known as neuroglycopenia. Clinical manifestations can include impaired cognition, loss of consciousness, and seizures. PBH is also associated with a high degree of disability that can result in major disruptions to independent living. There are no approved therapies for PBH. About the LUCIDITY Trial LUCIDITY (NCT06747468) is an approximately 75-participant, multicenter, randomized, double-blind, placebo-controlled Phase 3 clinical trial evaluating the efficacy and safety of avexitide in participants with PBH following Roux-en-Y gastric bypass (RYGB) surgery. The Phase 3 trial will be conducted at approximately 20 sites in the U.S. Participants will be randomized 3:2 to receive either 90 mg of avexitide subcutaneously once daily or placebo. The trial includes an up to six-week screening period, including a three-week run-in period, and a 16-week double-blind treatment period. Participants who complete the double-blind period will be eligible to enter an open-label extension (OLE) period with a duration of 32 weeks. The primary efficacy objective of LUCIDITY will evaluate the FDA-agreed upon primary outcome of reduction in the composite of Level 2 and Level 3 hypoglycemic events through Week 16. Safety and tolerability will also be evaluated. About Amylyx Pharmaceuticals At Amylyx, our mission is to usher in a new era of treating diseases with high unmet needs. Where others see challenges, we see opportunities that we pursue with urgency, rigorous science, and unwavering commitment to the communities we serve. We are currently focused on three investigational therapies across several neurodegenerative and endocrine diseases in which we believe they can make the greatest impact. For more information, visit and follow us on LinkedIn and X. For investors, please visit Forward-Looking Statements Statements contained in this press release regarding matters that are not historical facts are 'forward-looking statements' within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, Amylyx' expectations regarding: the potential of avexitide as a treatment for PBH; expectations regarding the timing for recruitment completion and topline data readout of the Phase 3 LUCIDITY trial of avexitide in PBH; and expectations regarding timing for potential commercialization of avexitide. Any forward-looking statements in this press release and related comments in the Company's earnings conference call are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. Risks that contribute to the uncertain nature of the forward-looking statements include: the success, cost, and timing of Amylyx' program development activities; Amylyx' ability to execute on its regulatory development plans and expectations regarding the timing of results from its planned data announcements and initiation of clinical studies; the risk that early-stage results may not reflect later-stage results; Amylyx' ability to fund operations, and the impact that global macroeconomic uncertainty, geopolitical instability, and public health events will have on Amylyx' operations, as well as the risks and uncertainties set forth in Amylyx' United States Securities and Exchange Commission (SEC) filings, including Amylyx' Annual Report on Form 10-K for the year ended December 31, 2024, and subsequent filings with the SEC. All forward-looking statements contained in this press release and related comments in our earnings conference call speak only as of the date on which they were made. Amylyx undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.
Buzz Feed
12 hours ago
- Buzz Feed
Are You Pooping Correctly? Try This Simple Technique
Among the current wave of wellness obsessions, fibermaxxing is gaining major traction. This more-is-more approach to fiber is touted on TikTok as a way to boost digestion, satiety and overall gut health while also addressing the fact that most Americans aren't getting enough. But while increasing your fiber intake has clear benefits, nutrition experts say there's a right way to do it if you want to see results. What is fibermaxxing? The TikTok trend is all about maximizing fiber intake by loading up every meal and snack with fiber-rich foods, and sometimes supplements, to support gut health, satiety, cholesterol levels, blood sugar stability and even cancer prevention. It reflects a growing shift away from protein-obsessed diets toward a stronger focus on digestive and colon health. But Jennifer House, a registered dietitian and owner of First Step Nutrition in Calgary, Alberta, cautions that if you have IBS or an inflammatory bowel condition like Crohn's disease or ulcerative colitis, a high-fiber diet might not be ideal. 'And if you suffer from constipation, increasing fiber all at once could temporarily make the situation worse.' How much fiber do we actually need? For women ages 18 to 50, the general recommendation is 25 grams of fiber per day, and 21 grams for those 51 and older, House said. For men, it's 30 grams daily. 'Most people only get about half of the recommended amount of fiber each day,' she added. Fiber is found only in plant-based foods, and there are five main groups that provide it: vegetables, fruits, legumes, whole grains, and nuts and seeds. Of these, legumes pack the biggest punch. Just one cup of beans contains 10 to 19 grams of fiber, which can get you more than halfway to your daily target. 'Animal foods don't contain fiber, so an eating pattern that's disproportionately high in meat, dairy and eggs is more likely to fall short on fiber,' said registered dietitian Avery Zenker. The health benefits of fiber: Fiber supports healthy digestion, helps regulate blood sugar and cholesterol levels, and promotes a sense of fullness that can aid in appetite and weight management. It's also linked to a lower risk of heart disease, type 2 diabetes and certain cancers, including colorectal and colon, Zenker noted. 'Low fiber diets are linked to microbiome imbalances and lower microbial diversity, both of which are associated with increased risk of inflammatory diseases.' Different types of fiber offer different benefits. 'Soluble fiber helps regulate blood sugar and lower cholesterol — great for patients with diabetes or heart disease risk,' said Dr. Michael Ednie, founder of Bespoke Concierge MD based in Scottsdale, Arizona. This type of fiber dissolves in water to form a gel that helps lower cholesterol and regulate blood sugar. 'Insoluble fiber promotes regularity and helps prevent constipation, which is crucial for colon health,' Ednie said. Then there's prebiotic fiber, which serves as food for the beneficial bacteria in your gut. 'As those bacteria ferment prebiotic fibers, they produce short-chain fatty acids like butyrate, which have anti-inflammatory effects and support gut barrier function. Prebiotics have also been linked to improved mineral absorption and even mood regulation via the gut-brain connection,' Ednie said. Garlic, onions, bananas and asparagus are all excellent sources. Just like variety in your overall diet supports better nutrition, eating different types of fiber helps build a healthier, more resilient gut microbiome. 'Different fibers feed different strains of beneficial bacteria, which leads to better gut health, stronger immune function and lower inflammation overall,' Ednie explained. While there's no strict formula for how much of each fiber type you need, he suggests aiming for about two-thirds insoluble fiber and one-third soluble fiber. Fibermaxxing can backfire on your digestive system. While there's no official upper limit for fiber intake, increasing it too quickly can cause gas, bloating and other digestive issues like cramping, constipation and diarrhea. 'The gut bacteria essentially go into overdrive trying to process the sudden influx of fiber, producing excess gas as a byproduct,' Ednie explained. 'In rare cases, if someone dramatically increases fiber without proper hydration or pacing, it can even lead to intestinal blockages that require medical attention.' The type of fiber you're increasing also affects the symptoms you may experience. 'Soluble fiber — found in foods like oats, apples and beans — tends to be gentler at first but often causes more gas because it's fermented by gut bacteria,' Ednie said. 'Insoluble fiber — from whole grains, vegetable skins and nuts — adds bulk and moves things along but can lead to more bloating and cramping if increased too quickly without enough water.' Zenker also notes that for some people, especially older adults and young children, the satiating effect of fiber may reduce overall food intake, potentially leading to unintended weight loss or nutrient gaps. Additionally, consuming too much fiber can interfere with the absorption of important minerals like iron, zinc and calcium by binding to them in the gut and preventing their absorption. Increasing your fluid intake is key. Hydration is essential when increasing fiber intake to help it do its job effectively. 'Soluble fiber needs water to form the gel that helps regulate blood sugar and cholesterol,' Ednie explained. 'Insoluble fiber needs water to add bulk and move stool efficiently through the digestive tract.' He recommends aiming for at least eight to 10 cups of water a day when boosting your fiber intake, and more if you're active or in a hot climate, and pairing every fiber-rich meal or snack with a full glass of water to support digestion. How to safely increase your fiber intake. Nutrition experts agree that it's important to increase fiber gradually to give your digestive system time to adjust and minimize the risk of bloating or discomfort. 'Instead of jumping from 10 grams a day to 30 overnight, add just 3 to 5 grams of fiber per week,' Ednie said. He also recommends spreading your fiber intake throughout the day, like enjoying oatmeal with berries in the morning, veggies or legumes at lunch and dinner, and snacks like fruit with nuts or popcorn in between. 'Consistency makes it much easier for the body to adapt and helps create sustainable habits that support long-term gut health,' he added. Ednie also emphasizes prioritizing whole foods as your main fiber source to support digestive, metabolic and cardiovascular health. These foods naturally contain a mix of soluble and insoluble fiber, along with vitamins, minerals and phytonutrients that fiber supplements don't offer. 'Supplements can be helpful for people who struggle to meet their fiber needs through diet alone, but they should be viewed as an addition, not a replacement,' he said. HuffPost.
Newsweek
17 hours ago
- Newsweek
Millions of Americans Advised to Avoid Going Outside
Based on facts, either observed and verified firsthand by the reporter, or reported and verified from knowledgeable sources. Millions of Americans living in states across the Midwest have been told to avoid going outside to avoid breathing in the wildfire smoke which has reached the region all the way from Canada. Wildfire season is off to a grim start this year in the Great White North. The Western province of Manitoba declared a state of emergency on Friday for the second time this year. In May, fires killed two people in Manitoba and forced 30,000 to flee their homes to neighboring Saskatchewan. More than 100 wildfires are burning across the region, over 20 of which were considered out of control as of Sunday morning, and thousands of people have been evacuated. It is a tragedy for the Canadian province, which has already reported 2.5 million acres of land burned by wildfires this year and which could soon see the most land burned since at least 1994. But as the smoke and ash from the Manitoba wildfires drifts south, the smoke has proved a problem for many Americans as well. Across The Border Wildfires in Canada are generating a cloud of toxic smoke that has made its way across the border and into the U.S, where it is affecting air quality. Roughly 22 million people in Minnesota, Wisconsin, Michigan are currently under statewide air quality alerts which are set to last until Monday morning. The risk is from inhaling fine-particle pollution—known as PM 2.5—which state agencies say could mean "unhealthy" to "very unhealthy" levels. Some areas of Minnesota are set to briefly reach the "very unhealthy" range. In Wisconsin, forecasters expect the heaviest smoke to reach locations farther north in the state, while the lowest concentrations of fine-particle pollution are expected across the southwest. In Michigan, the smoke is expected to expand across the state on Sunday, but the highest concentration of pollutants will be in the northern parts of the state. The southwest is likely to face moderate levels of PM 2.5. Minnesota experienced the heaviest smoke on Saturday, but on Sunday the air quality should begin to improve as clean air moves in from the west. The smoke should be gone by the end of the day from most of the state, forecasters say, while a new round of smoke could be coming on Sunday night for northern Minnesota. Parts of Colorado are also under air quality alerts, though these have nothing to do with the Canada wildfires. Several fires broke out in western Colorado this week, exacerbated by hot and dry conditions. Experts Recommend Staying Indoors The National Weather Service (NWS) recommends sensitive groups—including people with heart or lung disease, children, seniors and pregnant individuals—to avoid all physical activities outdoors. Those who are likely to feel affected by the smoke should go indoors, the agency said. Individuals with asthma should follow their asthma action plan and keep quick-relief medicine at hand. People with heart disease should contact their health providers if they feel symptoms including palpitations, shortness of breath, or unusual fatigue. Everyone else, the NWS said, should "keep outdoor activities shorter and less intense," even if they are not particularly vulnerable to air pollution. Residents under air quality alerts should also avoid activities that contribute to air pollution, including outdoor burning and the use of residential wood burning devices. They should also avoid vehicle trips and vehicle idling as much as possible, and keep their windows closed overnight to stop the smoke from coming into their homes. Spoiling the American Summer In a move that sparked controversy, a group of six Republican lawmakers from Minnesota and Wisconsin wrote a letter to Canada's ambassador to the U.S. Kirsten Hillman, complaining about the smoke from the wildfires burning in Manitoba preventing their constituents from enjoying the summer. "We write to you today on behalf of our constituents who have had to deal with suffocating Canadian wildfire smoke filling the air to begin the summer," wrote the group, which includes Tom Tiffany and Glenn Grothman of Wisconsin and Michelle Fischbach, Brad Finstad, Pete Stauber and Tom Emmer of Minnesota. "Our constituents have been limited in their ability to go outside and safely breathe due to the dangerous air quality the wildfire smoke has created," they said. "In our neck of the woods, summer months are the best time of the year to spend time outdoors recreating, enjoying time with family, and creating new memories, but this wildfire smoke makes it difficult to do all those things." The six members of Congress asked Hillman what her country was doing to mitigate the wildfire and "the smoke that makes its way south." The premier of Manitoba, Wab Kinew, said the letter was an attempt to "trivialize and make hay out of a wildfire season where we've lost lives in our province."
