Neurotic Disorders

The researchers studied decisions that more than 150 children ages 10 to 13 made while playing games that offered opportunities to risk a little and explore for potential gains. Trying something new is a risk every child undertakes as they explore and learn about the world. While risk can be costly, it can also pay off in rewards or knowledge. But new research suggests children without predictable support from the adults in their lives are less willing to take those risks -- and reap those rewards. "If you're in a resource-rich environment -- meaning for a child that you're safe, your meals are coming, someone is at home for you, you're surrounded by adults that are protecting you -- you'll try new things," says Seth Pollak, a University of Wisconsin-Madison professor of psychology who studies childhood adversity. "And that's how you discover and learn about the world." But not every exploration will be rewarding and, according to a new study of childhood exploration and parental predictability that Pollak and collaborators today published in the Proceedings of the National Academy of Sciences, kids who don't believe they have the support of reliable parents are less willing to risk the unknown. "What's unseen around that corner could be golden, but you could also end up in some bad situations," Pollak says. "You could end up ordering a bad meal or touching something that hurts you. You could end up in a bad relationship or with an empty wallet. And so, we thought, in order to have the confidence to try something new, you have to feel like you're supported and relatively safe -- like you can afford to make a bad call." The researchers studied decisions that more than 150 children ages 10 to 13 made while playing games designed by C. Shawn Green, a UW-Madison psychology professor. The games offered the children opportunities to risk a little and explore for potential gains. One game, fashioned after a pair of casino slot machines, gave players a history of payouts on just one of the machines -- information that helped them understand their expected winnings if they kept pulling that machine's handle. The other machine's history was a mystery, and investing a pull there was more of a risk, but also potentially a bigger return. The other game, in which the kids collected apples in virtual orchards, featured diminishing returns as players continued to pick from an individual tree. With limited time, would the players move to new trees, with unknown bounties? Or would they plug away at the tree they knew best? The kids and their parents also participated in a battery of surveys and assessments. The researchers gauged the stress the children experience and the predictability of their lives -- based on factors like parental job loss, divorce, death or illness in the family, and changing schools and homes -- as well as children's own views about whether or not their parents were reliable and predictable. Yuyan Xu, a UW-Madison graduate student and first author of the study, asked children to respond to questions about how they've experienced their relationships, such as: When my parents say they're going to pick me up, can I count on them to be there? When my parent makes a promise, do they follow through on it? Do I typically know how my parents are going to react to different kinds of situations? The less reliable and predictable the kids felt their parents were, the less likely they were to take exploratory risks in the games they played. They were less likely to give the mysterious slot machine a chance or choose to move to a different apple tree. "The children from more stable backgrounds, they play around and experiment in our games. They use that to get a sense of how things work, maybe earning them more money or more points," Pollak says. "Kids from unstable backgrounds just don't play that way. They stay within a narrower range of possibilities. They prefer to stick with what they already know, even if it's limited, rather than taking a chance at a higher possible reward." The researchers found those self-imposed limits on risk were not related to the more objective measures of stress and unpredictability on the kids' lives or even on parental reports that didn't necessarily agree with their child's perceptions of their relationships. There wasn't a correlation between lack of risk-taking and levels of anxiety or neuroses, or of the kids' feelings about the rest of the world outside their family. If they felt their parents were unreliable and unpredictable, they were less willing to explore. "I think it makes sense," Pollak says. "Their brains are doing exactly what we want our brains to do, right? If you really feel things are not predictable and you don't know how things are going to land, you'd stick to what works and what's familiar. You wouldn't waste your resources on something that could all fall apart." The researchers ran their experiments first with a group of nearly 80 kids, then repeated it with a second group of just over 80 more to confirm their results. "The interesting thing here is that there seems to be a way in which our early childhood experiences are calibrating how we decide to make these decisions years and years down the line and in these really different kinds of situations," says Xu. Openness to exploration wouldn't be the only important aspect of childhood enhanced by stability. Language development, sleep quality, stress regulation and other subjects of childhood development research have been tied to predictability in children's lives. Pollak plans to delve further into the relationship between predictability and exploration to see how rifts might be healed. "What can we do for kids who view their history of interpersonal relationships as unstable?" he says. "We might not be able to change the relationships by the time we understand them to be unpredictable. But could we change the way kids think about them, how they act on them? If that is flexible, maybe we can tune those kids into the benefits and rewards of exploration to help foster kids' learning." This research was supported by grants from the National Institutes of Health (R01MH61285 and P50HD105353).

CARSON CITY, Nev., Sept. 07, 2023 (GLOBE NEWSWIRE) -- BioVie Inc., (NASDAQ: BIVI) (“BioVie” or the “Company”), a clinical-stage company developing innovative drug therapies for the treatment of neurological and neurodegenerative disorders and advanced liver disease, is hosting today a virtual KOL event titled NE3107―Putting Data in Context, ahead of the upcoming Phase 3 results in Alzheimer’s Disease. The event will take place today at 2:30pm ET. To register, click here. The event will focus on BioVie’s lead product candidate, NE3107, currently in a potentially pivotal Phase 3 study in patients with mild to moderate Alzheimer’s disease with expected topline data readout in the fourth quarter of 2023. The company’s leadership team and Key Opinion Leader (KOL) Steven E. Arnold, MD (Harvard Medical School; Massachusetts General Hospital) will discuss the totality of NE3107 data generated to date including: The role of neuroinflammation and insulin resistance in Alzheimer’s Disease pathology.The potential for NE3107 to have an active epigenetic effect associated with improvements in inflammation, insulin signaling, and other critical biological processes in a manner that is significantly correlated to improvements in cognition.An overview of results observed in the NE3107 Phase 2 exploratory biomarker study. A live question and answer session will follow the formal presentations. About Steven E. Arnold, MDAfter receiving his MD from Boston University, Dr. Arnold completed residency training in Psychiatry at the New York State Psychiatric Institute / Columbia Presbyterian Medical Center in New York, residency training in Neurology and fellowship training in Behavioral Neurology at the University of Iowa Hospitals and Clinics in Iowa City. Dr. Arnold is board certified in both neurology and psychiatry. At the Massachusetts General Hospital, Dr. Arnold leads the Alzheimer's Clinical and Translational Research Unit, conducting early phase clinical trial and biomarker research. He is also Managing Director of the Interdisciplinary Brain Center, a new collaboration of the Departments of Neurology, Psychiatry and Radiology. Its mission is to facilitate the discovery, development, and implementation of promising therapeutics and associated diagnostics for individuals with complex brain disorders affecting cognition, behavior and emotion. Dr. Arnold has conducted longstanding research on neurodegenerative disease pathology, molecular biomarkers and therapeutics for cognitive decline and psychiatric syndromes in late life and has led broad clinical and translational research programs. He has authored over 250 scientific articles, reviews and chapters. Current scientific interests include biomarkers in brain aging and dementias, metabolic factors driving dementia, and protective factors that account for cognitive resilience, all with the goal of accelerating therapeutics discovery and development. About BioVieBioVie Inc. (NASDAQ: BIVI) is a clinical-stage company developing innovative drug therapies for the treatment of neurological and neurodegenerative disorders and advanced liver disease. In neurodegenerative disease, the Company’s drug candidate NE3107 inhibits inflammatory activation of ERK and NFkB (e.g., TNF signaling) that leads to neuroinflammation and insulin resistance, but not their homeostatic functions (e.g., insulin signaling and neuron growth and survival). Both are drivers of Alzheimer’s and Parkinson’s diseases. The Company is conducting a potentially pivotal Phase 3 randomized, double-blind, placebo-controlled, parallel-group, multicenter study to evaluate NE3107 in patients who have mild to moderate probable Alzheimer's disease (NCT04669028). Results of a Phase 2 investigator-initiated trial (NCT05227820) showing NE3107-treated patients experienced improved cognition and biomarker levels were presented at the Clinical Trial in Alzheimer’s Disease (CTAD) annual conference in December 2022. An estimated six million Americans suffer from Alzheimer’s. A Phase 2 study of NE3107 in Parkinson’s disease (NCT05083260) has completed, and data presented at the International Conference on Alzheimer's and Parkinson's Disease and Related Neurological Disorders conference in Gothenburg, Sweden in March 2023 showed significant improvements in “morning on” symptoms and clinically meaningful improvement in motor control in patients treated with a combination of NE3107 and levodopa vs. patients treated with levodopa alone, and no drug-related adverse events. In liver disease, the Company’s Orphan drug candidate BIV201 (continuous infusion terlipressin), with FDA Fast Track status, is being evaluated in a US Phase 2b study for the treatment of refractory ascites due to liver cirrhosis. BIV201 is administered as a patent-pending liquid formulation. The active agent is approved in the U.S. and in about 40 countries for related complications of advanced liver cirrhosis. For more information, visit http://www.bioviepharma.com/. Forward-Looking StatementsThis press release contains forward-looking statements, including statements regarding the Company’s strategy, plans and objectives. Forward-looking statements may generally be identified by words such as "expect," "look forward to," "anticipate" "intend," "plan," "believe," "seek," "estimate," "will," "project" or words of similar meaning. Although BioVie Inc. believes such forward-looking statements are based on reasonable assumptions, it can give no assurance that its expectations will be attained. Actual results may vary materially from those expressed or implied by the statements herein due risks associated with conducting and completing clinical trials, including our reliance on third parties to conduct our clinical trials, to successfully defend potential future litigation, our ability to raise capital when needed on reasonable terms, changes in local or national economic conditions as well as various additional risks, many of which are now unknown and generally out of the Company's control, and which are detailed from time to time in reports filed by the Company with the SEC, including quarterly reports on Form 10-Q, reports on Form 8-K and annual reports on Form 10-K. BioVie Inc. does not undertake any duty to update any statements contained herein (including any forward-looking statements), except as required by law. For Public/Press Relations Inquiries:Contact:Anna Marie David630-550-7510annamarie@quantum-corp.com For Investor Relations Inquiries:Contact:Bruce MackleManaging DirectorLifeSci Advisors, LLCbmackle@lifesciadvisors.com

Biogens freshly minted CEO told investors Wednesday that the company is in need of transformation, and will be working to reduce the costs and risks associated with its pipeline of drug programs.Our number one goal is to return Biogen to sustainable growth, said Christopher Viehbacher, the former Sanofi chief executive who took over Biogens top spot in mid-November, on an earnings call.Biogens business largely revolves around neuroscience, an area of drug research seen by many as risky given the complicated nature of the brain and nervous system. Last year alone, the company discontinued work on experimental medicines for Alzheimers disease, ALS and schizophrenia-associated cognitive impairment.On the call, Viehbacher noted how, in neuroscience, diseases often progress slowly, so collecting the evidence needed to show a drug works as expected can require long, large and expensive clinical trials.Having a few of those projects in our pipeline is good, he said, having 100% ... is challenging.The goal now, according to Biogen leadership, is to rebalance the companys pipeline. And that effort includes more cuts. Priya Singhal, head of development and interim head of research, disclosed Wednesday that two more drugs are being scrapped: one, called vixotrigine, was under evaluation as a treatment for neuropathic pain, while the other, orelabrutinib, was in testing for multiple sclerosis.There have been a number of pet projects around and other areas where we're spending money, Viehbacher said. And I think one of the things I'm really trying to drive is focus in the company what really matters, what's going to grow the business and how do we align our resources behind that.Whenever it's not one of the major growth drivers, I think we have to look carefully at whether we continue ... to support that business, he added.Historically, Biogens focus on neuroscience hasnt always sat well with investors, and, in the past, the company has made moves to diversify its research. To that end, Viehbacher said he could see Biogen branching deeper into immune disorders, psychiatric conditions and rare diseases.And to do that, the company may look externally.Unlike many of its peers, Biogen hasnt pursued bigger-ticket acquisitions since its merger with Idec two decades ago. That stance could change, though, with a new chief executive at the helm. Viehbacher, notably, signed off on Sanofis $20 billion purchase of Genzyme in 2011.Biogen hasn't necessarily looked at acquisitions as part of its growth strategy, he said. But, I tell people, Well, there wasn't a lot of point hiring me if you don't want to go do deals.So not to say we are, but I think there is now an openness within the company to at least look at it.By the end of December, Biogen had $6 billion worth of cash, cash equivalents, and marketable securities. The company also expects to receive an additional $1.25 billion over the next 15 months from the sale of its equity stake in Samsung Bioepis.Aside from dealmaking, Biogen will also be focused on launching two products considered vital to its near-term growth.The first, zuranolone, was developed by Sage Therapeutics, though Biogen secured rights to it through a multibillion-dollar collaboration inked in 2020. The Food and Drug Administration is currently reviewing zuranolone as a potential treatment for major depressive disorder and postpartum depression, and plans to issue an approval verdict by early August.The second, Leqembi, is already FDA-approved for the treatment of Alzheimers. Wall Street believes Leqembi could generate billions of dollars in annual sales, provided it can overcome the challenges that ultimately derailed Biogens first marketed Alzheimers therapy, Aduhelm.Currently, the commercial use of drugs like Aduhelm and Leqembi which were given so-called accelerated approvals because of their effect on a protein tied to Alzheimers is heavily restricted. Thats in large part because of a policy set by Medicare, the government insurance program expected to cover the bulk of patients eligible to receive these drugs. Biogen predicts that Leqembi revenue will be “modest“ this year, with commercialization expenses exceeding revenue.Many more patients could receive Leqembi, if Biogen and its development partner, Eisai, were to secure a traditional clearance. Eisai has taken steps toward that goal, submitting in early January an application for full approval.Last week, in its own earnings presentation, Eisai said that Leqembi had its first U.S. sale on Jan. 18, its first prescription written on Jan. 23, and its first administration to a patient on Feb. 3.Biogens total revenue in the fourth quarter was 7% lower than the same three-month period a year prior, reaching $2.5 billion. Total revenue for all of 2022 was also down 7%, to almost $10.2 billion.Around half of Biogens revenue still comes from multiple sclerosis medicines like Tecfidera, Tysabri and Vumerity, although a recent loss of patent protection has eroded Tecfidera sales. Viehbacher said he anticipates shifting some of the resources used to sell and market the companys multiple sclerosis franchise to other drug launches.The company reported single-digit increases in sales from its spinal muscular atrophy drug Spinraza as well as a suite of therapies developed in collaboration with Roches Genentech.Though Biogens share price was relatively unchanged at markets open Wednesday, it had fallen about 3%by late morning, to trade at about $280. '