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Yahoo
19-05-2025
- Health
- Yahoo
Altimmune Announces Initiation of RECLAIM Phase 2 Trial Evaluating the Efficacy and Safety of Pemvidutide in Alcohol Use Disorder (AUD)
GAITHERSBURG, Md., May 19, 2025 (GLOBE NEWSWIRE) -- Altimmune, Inc. (Nasdaq: ALT), a late clinical-stage biopharmaceutical company developing novel peptide-based therapeutics for liver and cardiometabolic diseases, today announced that it has enrolled the first subject in the RECLAIM Phase 2 trial evaluating the efficacy and safety of pemvidutide in subjects with Alcohol Use Disorder (AUD). Pemvidutide is a novel, investigational GLP-1/glucagon dual receptor agonist under development for the treatment of metabolic dysfunction-associated steatohepatitis (MASH), obesity, AUD and alcohol liver disease (ALD). IMPACT, a Phase 2b trial of pemvidutide in MASH, is expected to read out topline data in the second quarter of 2025, and a Phase 2 trial of pemvidutide in ALD is expected to initiate enrollment in the third quarter of 2025. RECLAIM is a randomized, placebo-controlled trial being conducted at approximately 15 sites in the United States, with Dr. Henry Kranzler, Karl E. Rickels Professor of Psychiatry and Director, Center for Studies of Addiction at the University of Pennsylvania Perelman School of Medicine, serving as the Principal Investigator. The trial is expected to enroll approximately 100 subjects randomized 1:1 to receive either 2.4 mg pemvidutide or placebo weekly for 24 weeks. The primary endpoint of the trial is a change in alcohol consumption, assessed as the change from baseline in the average number of heavy drinking days per week at Week 24, with the key secondary endpoints including the proportion of subjects achieving a 2-level reduction in World Health Organization (WHO) risk drinking level and the absolute change from baseline in average levels of phosphatidylethanol (PEth), a serum biomarker of alcohol intake. An investigational new drug (IND) application for pemvidutide in AUD was filed in December 2024 and was cleared by FDA in January 2025. 'Over 28 million individuals in the U.S. alone have AUD, and the lack of effective treatments has resulted in one of the largest known treatment gaps in this country,' said Dr. Kranzler. 'It has been estimated that less than 10% of patients are currently receiving treatment for AUD and that 2% or less are being treated with any of the 3 medications approved for AUD in the US1. These medications were approved decades ago and have limited beneficial effects and inadequate compliance rates. Thus, there is an urgent need for new therapies for AUD.' 'There are compelling data that GLP-1 agents may reduce the craving for alcohol in addition to reducing food consumption,' said Scott Harris, M.D., Chief Medical Officer of Altimmune. 'In a preclinical hamster model of free-choice alcohol intake, pemvidutide demonstrated a greater than 80% reduction in alcohol preference after the initiation of treatment2. Importantly, AUD is the precursor for alcohol liver disease (ALD), a disease characterized by excess liver fat, liver inflammation and fibrosis with features similar to MASH. In addition, obesity is a major risk factor for MASH, AUD and ALD, and because excess alcohol is a known risk factor for hypertension and dyslipidemia, patients with AUD could benefit further from the metabolic effects of pemvidutide.' About Altimmune Altimmune is a late clinical-stage biopharmaceutical company focused on developing novel peptide-based therapeutics for liver and cardiometabolic diseases. The Company's lead program is pemvidutide, a GLP-1/glucagon dual receptor agonist for the treatment of MASH, obesity, Alcohol Use Disorder (AUD) and Alcohol Liver Disease (ALD). For more information, please visit Follow @Altimmune, Inc. on LinkedInFollow @AltimmuneInc on X Forward-Looking StatementAny statements made in this press release related to the development or commercialization of product candidates and other business and financial matters, including without limitation, trial results and data, the timing of key milestones for our clinical assets, and the prospects for the utility of, regulatory approval, commercializing or selling any product or drug candidates, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In addition, when or if used in this press release, the words "may," "could," "should," "anticipate," "believe," "estimate," "expect," "intend," "plan," "predict" and similar expressions and their variants, as they relate to Altimmune, Inc. may identify forward-looking statements. The Company cautions that these forward-looking statements are subject to numerous assumptions, risks, and uncertainties, which change over time. Important factors that may cause actual results to differ materially from the results discussed in the forward looking statements or historical experience include risks and uncertainties, including risks relating to: delays in regulatory review, manufacturing and supply chain interruptions, access to clinical sites, enrollment, adverse effects on healthcare systems and disruption of the global economy; the reliability of the results of studies relating to human safety and possible adverse effects resulting from the administration of the Company's product candidates; the Company's ability to manufacture clinical trial materials on the timelines anticipated; and the success of future product advancements, including the success of future clinical trials. Further information on the factors and risks that could affect the Company's business, financial conditions and results of operations are contained in the Company's filings with the U.S. Securities and Exchange Commission, including under the heading "Risk Factors" in the Company's most recent annual report on Form 10-K and our other filings with the SEC, which are available at Company Contact:Greg WeaverChief Financial OfficerPhone: 240-654-1450ir@ Investor Contact:Lee RothBurns McClellanPhone: 646-382-3403lroth@ Media Contact:Jake RobisonInizio Evoke, BiotechPhone: 1 SAMHSA 2023 NSDUH Survey 2 Altimmune R&D Day Presentation, slide #47 This press release was published by a CLEAR® Verified individual.
Yahoo
28-01-2025
- Health
- Yahoo
If You Did Dry January, Read This Before You Jump Back Into Drinking
Giacomo Gambineri This article is part of Dry January, Straight Up, your no-BS guide to cutting out alcohol for 31 days—or longer. SELF will be publishing new articles for this series throughout January. Read more here. Dry January can turn some folks into sobriety evangelists: They dropped the booze and found their skin brighter, their energy boundless, their focus sharper, or some other life-changing effect that inspires them to quit drinking forever. (Good for them!) But it's also possible for an alc-free month to be less…revelationary. Perhaps you felt a little clearer-headed or slept more deeply—just not enough to swear off dirty martinis for life. Or for whatever other valid reason, you're planning on drinking alcohol again after taking a break in January. Just know that much like cutting the hard stuff out, reintroducing it can be an adjustment. That dry-to-wet transition will be most noticeable if you're someone who would typically down at least one or two drinks a day (or the equivalent number in a week), because you likely had developed a good deal of tolerance previously, Henry Kranzler, MD, director of the Center for Studies of Addiction at the University of Pennsylvania's Perelman School of Medicine, tells SELF. A boozeless month will have knocked that tolerance down, so drinking again after Dry January hits a lot harder—especially if you go right back to your normal quantity. It's the same reason going dry likely affected you more in the first place if you were a frequent vs. occasional drinker: The pendulum swing is greater in both directions. But even if you weren't drinking heavily beforehand and don't plan to do so now, you may find that any amount of alcohol affects you differently after a monthlong break from it. And any positive changes you experienced from stopping drinking are bound to fizzle once you pick it back up again, especially if you go harder on the alc than you did before—which is a common temptation. Below, experts share what you should know about drinking again after a break, and how to smoothly reincorporate alcohol into your life, if you choose to do so. Returning to alcohol after restricting yourself from the stuff could lead you to drink even more than you were before. In studies conducted with lab animals, this is called the 'alcohol deprivation effect,' Dr. Kranzler says: When they're given daily access to alcohol for a long time in their feed and then abruptly denied it for a brief period before regaining access again, they tend to up their intake beyond what they were initially consuming, at least temporarily. This exact mechanism hasn't been shown in people (largely because of ethical reasons around supplying and restricting booze), but it's been posed as a model of how we might behave when it comes to alcohol dependence. The reason why we might chase the opposite extreme after a dry spell isn't totally clear, but it's often compared to the tendency to binge-eat after doing a restrictive diet, Sarah Wakeman, MD, medical director for the Mass General Hospital Substance Use Disorder Initiative, tells SELF. 'If you feel like you've been deprived, there is a natural instinct to push back or even celebrate what you've achieved,' she says. That can quickly devolve into all-or-nothing thinking, she explains, or the idea that if you're no longer dry, you might as well get plastered. But of course, such overcompensating can undo any benefit of what you just did, which is why Dr. Wakeman advises being mindful of this inclination and making a point to reintroduce alcohol gradually (say, having one or two drinks on the first few occasions). On top of potentially being tempted to drink even more than you did pre-January, you might also be more susceptible to alcohol's effects after a dry spell. Here's why: When you regularly bathe your cells in alcohol, they adapt to the effects of the substance—but once you press pause, 'those neurochemical changes begin to reverse,' Dr. Kranzler explains. Your tolerance, then, regresses back toward whatever it was when you first started drinking, he says. Again, that shift will be most pronounced in folks who drank regularly enough to develop a significant tolerance to begin with, versus people who only sipped on occasion. But Dr. Wakeman emphasizes that nearly everyone will have some change in their tolerance if they completely cut out alc for a month. So, 'if you don't take that into account and you immediately go back to drinking as much as you ordinarily would, you could find yourself more intoxicated than you expected,' Dr. Kranzler says. Cue: blacking out on February 1 (and waking up with a raging hangover on February 2). By being aware of this potential change, however, you can reframe it as a positive, Dr. Wakeman says. Maybe you used to need three or four drinks to really feel something, and that was adding up to 15 or 20 drinks a week—which is well above the level deemed moderate (and lower risk) by the Dietary Guidelines for Americans (that is, one drink a day for people assigned female at birth and up to two drinks a day for people assigned male). Now, post-Dry January, you might get the same effect from, say, one or two drinks in a sitting, which would be a win for both your health and your wallet. Two things can be true: No amount of alcohol is good for your mind and body—or, as Dr. Wakeman puts it, 'you should never start drinking for your health.' And also, you might want alcohol to play some role in your life once you finish Dry January. 'There are lots of things we do that we don't do explicitly because they make our health better,' Dr. Wakeman points out. But at the same time, you don't want to negate the benefits of the dry month you successfully observed. While there's research to suggest that even a single month off from drinking can bring meaningful improvements to your health, like giving your liver a chance to repair itself and lowering your blood pressure, you'll toss all that out the window if you wind up drinking more after Dry January ends than you were before. It's important to know that one month of eliminating alcohol, in and of itself, 'isn't going to fix anything permanently,' Elizabeth Kovacs, PhD, director of the alcohol research program at the University of Colorado Anschutz Medical Campus, tells SELF. 'What would be more beneficial is drastically cutting down from, say, 14 drinks a week to maybe three [per week] for the rest of your life,' she says. In other words, being a moderate drinker forever is better than doing a fully dry month each year only to get sloshed in the weeks or months to follow. So even if Dry January didn't change your life so dramatically that you decided to cut out alcohol, consider what it might have shown you about your relationship with booze that could help you strike a balance going forward. Maybe the takeaway was that you're actually drinking lightly enough that you're not having any negative consequences from it—and you're going to reinstate your 'damp' way of life in February and beyond, Dr. Wakeman says. Or perhaps you identified social settings in which you had really just been drinking because you always have or because others were, and you didn't actually need any alcohol to have fun, Dr. Kovacs says. And maybe you can skip the hard stuff in those scenarios going forward, without it feeling like any kind of a loss. The point is to tune in and be a little more mindful about when, why, and in what circumstances you're drinking as you restart—versus just instinctively jumping back in where you left off or rebounding toward even heavier tippling. (Dr. Kovacs also recommends not partaking on an empty stomach and alternating hard drinks with water or nonalcoholic beverages to avoid getting accidentally drunk on your first days back.) This way, you'll hold onto the momentum you've gained—and choose to imbibe with as much intention and clarity as you put toward bypassing the booze last month. Related: 6 Signs Your Relationship With Alcohol Might Not Be Healthy 9 Ways to Say No to Alcohol When Someone Won't Mind Their Damn Business You Don't Need 'Liquid Courage' to Have Good Sex Get more of SELF's great service journalism delivered right to your inbox. Originally Appeared on Self
