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Lithium-Sparing Alzheimer’s Therapy has Strong Benefit-to-Risk Profile

On the strength of data from Alzamend Neuro’s Phase I study of its lead compound AL001 being developed for the treatment of Alzheimer’s disease, the company is looking to commence a Phase II multiple ascending dose study for that indication during the…

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Lithium-Sparing Alzheimer’s Therapy has Strong Benefit-to-Risk Profile

On the strength of data from its Phase I study of lead compound, AL001, being developed for the treatment of Alzheimer’s disease, Alzamend Neuro is looking to commence a Phase II multiple ascending dose study for that indication during the second quarter of this year.

AL001, also known as LiProSal, is a patented new formulation that delivers lithium orally through a crystal-engineered combination of lithium, L-proline and salicylate and was shown to be bioequivalent to the 300mg marketed lithium carbonate product.

“It has the potential to reduce the lithium dose needed to achieve efficacy for multiple neurodegenerative and psychiatric medical conditions,” Stephan Jackman, CEO of Alzamend Neuro, an early clinical-stage company, told BioSpace. In this trial, the dose of lithium was half that of the currently marketed lithium-based drugs treating Alzheimer’s disease.

The significantly lower level of lithium per dose is notable and is expected to give this drug a key advantage against competitors. As Jackman explained, other lithium carbonate and currently marketed lithium products are constrained by a very narrow margin between efficacy and toxicity. Therefore, they have a narrow therapeutic index and require therapeutic monitoring via routine blood tests, he said. For example, for currently-marketed lithium salts, “An often-cited reference range for therapeutic blood levels of lithium is 0.8-1.2 mEq/L. Levels above 1.2 mEq/L are often associated with toxicity, so clinicians monitor lithium levels in blood routinely to avoid side effects.”

Courtesy of Alzamend Neuro

By halving the usual lithium dose used to treat bipolar disease using lithium salts, the likelihood of detecting lithium concentrations in the blood that exceed 1.2 mEq/L is small. The comparatively low-dose AL001, therefore, reduces potential side effects and eliminates the need for routine blood tests to monitor lithium levels, thus conferring a definite benefit to patients.

Salicylate levels also are well within safety tolerances. In fact, “The amount of salicylate absorbed from AL001 (at the equivalent lithium dose of lithium carbonate 150 mg) is the same as that absorbed from two and a quarter 325 mg aspirin tablets,” Jackman said. “That’s close to the labeled over-the-counter dosage for pain, fever and inflammation.” Consequently, the benefit-to-risk relationship of this formulation (administered by a medical professional) appears favorable, especially when the paucity of available treatments for Alzheimer’s disease is considered.

Topline data from the Alzheimer’s study that Alzamend released in mid-December “confirms AL001’s potential as a replacement for current lithium-based treatments,” Jackman said. “The completed Phase 1 study for AL001-ALZ01 showed that the rate and extent of lithium absorption/persistence in blood (and therefore for most organs in the body) are closely comparable between AL001 and lithium carbonate.

“Such findings may serve as surrogate endpoints,” Jackman added, aided by data already in the public domain. Combined, this body of evidence may “mitigate or obviate some requirements for Phase II and III studies for safety and/or efficacy.” That possibility could come into play in indications for other disorders for which lithium is a treatment, as well as for new indications.

For example, preclinical data in mice suggested AL001 also may prove effective in preventing cognitive deficits, depression and irritability, and that it improved associative learning, memory and irritability when compared to lithium salt treatments. Data suggest this may be related to differences in uptake and persistence in the target organ for efficacy – the brain – between AL001 and lithium carbonate. Therefore, its range of indications may be expanded to include such neurodegenerative and psychiatric conditions as amyotrophic lateral sclerosis (ALS), Parkinson’s disease and bi-polar disorder.

As this drug advances through the clinic, one of the greatest challenges – one shared by all clinical-stage Alzheimer’s researchers – is the timely recruitment of qualifying Alzheimer’s patients for clinical studies. According to the most current analysis, in the U.S. in 2020, the 152 Alzheimer’s trials listed on ClinicalTrials.gov required 38,826 participants and 2,540,014 participant weeks, in addition to clinician time spent screening and managing patients, according to Jeffrey Cummings of the University of Nevada, and colleagues, in “Alzheimer’s disease drug development pipeline: 2021”, published in Alzheimer’s & Dementia, the journal of the Alzheimer’s Association.

In nearly all cases, recruitment time exceeds the time required for the treatment portion of the trials and the anticipated completion date. COVID-19 only exacerbated an existing problem. As the previous year’s report, published in 2020, noted, “The mean difference between the actual completion date and the anticipated completion date was 30 weeks for completed trials in Phase 1, 32 weeks for Phase 2 and 72 weeks for Phase 3, respectively.”

Such delays in recruitment are expected to be at least partially offset by a large body of relevant studies in the public domain. As Jackman stressed, “The lithium, salicylate and L-proline components of the engineered crystal are well-characterized and can be repurposed to address new indications and improve treatments for extant indications. Since the data already is extensive…the regulatory burden can be expected to be inherently mitigated.”

He noted the publication of multiple preclinical and clinical studies that suggest a positive outcome for lithium – and, by extension, AL001 – as a treatment for Alzheimer’s disease. There are also extensive safety data in the public domain relevant to the lithium, salicylate and L-proline components of AL001. To avoid redundant clinical efforts and to avoid subjecting frail subjects unnecessarily to the rigors of clinical trials, referencing this extensive literature for regulatory authorities can serve to reduce the need to reproduce such data and trials de novo.

Going forward, Alzamend is looking toward launching a Phase II study for Alzheimer’s disease in the second quarter of 2022 and also is continuing to refine the formulation. The treatment currently is administered three times each day but, Jackman said, “We are working on a formulation specifically designed to minimize the burden of drug administration for Alzheimer’s patients.”

BioSpace source:

https://www.biospace.com/article/lithium-sparing-alzheimer-s-therapy-has-strong-benefit-to-risk-profile-

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Economics

5 Top Consumer Stocks To Watch Right Now

Are these consumer stocks a buy amid the earnings season?
The post 5 Top Consumer Stocks To Watch Right Now appeared first on Stock Market News, Quotes,…

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5 Trending Consumer Stocks To Watch In The Stock Market Now         

As we tread through the earnings season, consumer stocks could be worth watching in the stock market this week. This would be the case since a number of big consumer names such as Costco (NASDAQ: COST) and Macy’s (NYSE: M) will be posting their financials for the quarter. As such, investors will be keeping an eye on these reports for clues on the strength of consumer spending amid this period of high inflation.

However, despite the soaring prices across the economy, it seems that consumers are surprisingly showing resilience. According to the Commerce Department, retail sales in April outpaced inflation for a fourth straight month. This could suggest that consumers as a whole were not only sustaining their spending, but spending more even after adjusting for inflation. Ultimately, it could be a reassuring sign that consumers are still supporting the economy and helping to diminish the narrative of an incoming recession. With that being said, here are five consumer stocks to check out in the stock market today.

Consumer Stocks To Buy [Or Sell] Right Now

Nordstrom

retail stocks (JWN stock)

Starting off our list of consumer stocks today is Nordstrom. For the most part, it is a fashion retailer of full-line luxury apparel, footwear, accessories, and cosmetics among others. The company operates through multiple retail channels, boutiques, and online as well. As it stands, Nordstrom operates around 100 stores in 32 states in the U.S. and three Canadian provinces.

Yesterday, the company reported its financials for the first quarter of 2022. Starting with revenue, Nordstrom pulled in net sales worth $3.47 million for the quarter. This marks an increase of 18.7% from the same quarter last year. Its Nordstrom banner saw net sales rise by 23.5% year-over-year, exceeding pre-pandemic levels. Next to that, its Nordstrom Rack banner saw a 10.3% increase in net sales from last year. Besides, net earnings were $20 million, with earnings per share of $0.13 for the quarter. Considering Nordstrom’s solid quarter, should you invest in JWN stock?

[Read More] Best Stocks To Invest In Right Now? 5 Value Stocks To Watch This Week

The Wendy’s Company

best consumer stocks (WEN stock)

Next up, we have The Wendy’s Company. For the most part, it is the holding company for the major fast-food chain, Wendy’s. Being one of the world’s largest hamburger fast-food chains, the company boasts over 6,500 restaurants in the U.S. and 29 other countries. The chain is known for its square hamburgers, sea salt fries, and the Frosty, a form of soft-serve ice cream mixed with starches. WEN stock is rising by over 8% on today’s opening bell.

According to an SEC filing, Wendy’s largest shareholder, Trian Partners, is looking into making a potential deal with the company. Trian said that it is considering a deal to “enhance shareholder value.” Also, the firm adds that this could lead to an acquisition or business combination. In response, Wendy’s stated that it is constantly reviewing strategic priorities and opportunities. It added that the company’s board will carefully review any proposal from Trian. Given this piece of news, will you be watching WEN stock?

[Read More] 4 Semiconductor Stocks To Watch In The Stock Market Today

Foot Locker

FL stock

Another stock investors could be watching is the shoes and apparel company, Foot Locker. In brief, the company uses its omnichannel capabilities to bridge the digital world and physical stores. As such, it provides buy online and pickup-in-store services, order-in-store, as well as the growing trend of e-commerce. Some of its most notable brands include Eastbay, Footaction, Foot Locker, Champs Sports, and Sidestep. Last week, the company reported its results for the first quarter of the year.

For starters, total sales came in at $2.175 billion, a slight uptick compared to sales of $2.153 billion in the year prior. Next to that, Foot Locker reported a net income of $133 million. Accordingly, adjusted earnings per share came in at $1.60, beating Wall Street’s expectations of $1.54. CEO Richard Johnson added, “Our progress in broadening and enriching our assortment continues to meet our customers’ demand for choice. These efforts helped drive our strong results in the first quarter, which will allow us to more fully participate in the robust growth of our category going forward.”  As such, is FL stock one to add to your watchlist? 

Tyson Foods 

TSN stock

Tyson Foods is a company that built its name on providing families with wholesome and great-tasting protein products. Its segments include Beef, Pork, Chicken, and Prepared Foods. With some of the fastest-growing portfolio of protein-centric brands, it should not be surprising that TSN stock often comes to mind when investors are looking for the best consumer stocks to buy. 

Earlier this month, Tyson Foods provided its fiscal second-quarter financial update. The company’s total sales for the quarter were $13.1 billion, representing an increase of 15.9% compared to the prior year’s quarter. Meanwhile, its GAAP earnings per share climbed to $2.28, up 75% year-over-year. According to Tyson, these financial figures are a reflection of the increasing consumer demand for its brands and products. To top it off, the company was also able to reduce its total debt by approximately $1 billion. Thus, does TSN stock have a spot on your watchlist?

[Read More] Stock Market Today: Dow Jones, S&P 500 Rise, Wendy’s Stock Gains On Potential Deal

DoorDash

food delivery stocks (DASH Stock)

DoorDash is a consumer company that operates an online food ordering and delivery platform. In fact, it is one of the largest delivery companies in the U.S. and enjoys a huge market share. The company connects hundreds of thousands of merchants to over 25 million consumers in the U.S., Canada, Australia, and Japan through its local logistics platform. Accordingly, its platform allows local businesses to thrive in today’s “convenience economy,” as the company puts it.

On May 5, the company reported its first-quarter financials for 2022. Diving in, it posted a revenue of $1.5 billion, growing by 35% year-over-year. This was driven by total orders that grew by 23% year-over-year to $404 million. Along with that, it reported a GAAP gross profit of $662 million, an increase of 34% year-over-year. The company said that it added more consumers than any quarter since Q1 2021, due in part to the growth of its DashPass members. The growth in Monthly Active Users and average order frequency has helped it gain share in the U.S. Food Delivery category this quarter as well. Given DoorDash’s performance for the quarter, should you watch DASH stock?

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The post 5 Top Consumer Stocks To Watch Right Now appeared first on Stock Market News, Quotes, Charts and Financial Information | StockMarket.com.

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Economics

Philly Fed: State Coincident Indexes Increased in 50 States in April

From the Philly Fed: The Federal Reserve Bank of Philadelphia has released the coincident indexes for the 50 states for April 2022. Over the past three months, the indexes increased in all 50 states, for a three-month diffusion index of 100. Additiona…

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From the Philly Fed:
The Federal Reserve Bank of Philadelphia has released the coincident indexes for the 50 states for April 2022. Over the past three months, the indexes increased in all 50 states, for a three-month diffusion index of 100. Additionally, in the past month, the indexes increased in all 50 states, for a one-month diffusion index of 100. For comparison purposes, the Philadelphia Fed has also developed a similar coincident index for the entire United States. The Philadelphia Fed’s U.S. index increased 1.1 percent over the past three months and 0.3 percent in April.
emphasis added
Note: These are coincident indexes constructed from state employment data. An explanation from the Philly Fed:
The coincident indexes combine four state-level indicators to summarize current economic conditions in a single statistic. The four state-level variables in each coincident index are nonfarm payroll employment, average hours worked in manufacturing by production workers, the unemployment rate, and wage and salary disbursements deflated by the consumer price index (U.S. city average). The trend for each state’s index is set to the trend of its gross domestic product (GDP), so long-term growth in the state’s index matches long-term growth in its GDP.
Click on map for larger image.

Here is a map of the three-month change in the Philly Fed state coincident indicators. This map was all red during the worst of the Pandemic and also at the worst of the Great Recession.

The map is all positive on a three-month basis.

Source: Philly Fed.

Philly Fed Number of States with Increasing ActivityAnd here is a graph is of the number of states with one month increasing activity according to the Philly Fed. 

This graph includes states with minor increases (the Philly Fed lists as unchanged).

In April all 50 states had increasing activity including minor increases.

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Economics

Finding Shelter in an Inverse ETF

As the old saying goes, “What goes up must come down.” Indeed, up until the recent selling wave caused by Russia’s war against Ukraine and the continued…

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As the old saying goes, “What goes up must come down.”

Indeed, up until the recent selling wave caused by Russia’s war against Ukraine and the continued effects of supply chain disruptions amid the COVID-19 pandemic, tech stocks, including semiconductors, were the darlings of the investment world. That is, it seemed as if the sky-high valuations of some tech stocks were sustainable in an atmosphere of seemingly perpetual growth.

That, of course, was not the case, and the too-good-to-be-true valuations were quickly brought down to earth by the forces of inflation and tight monetary policy. As a result, the tech-heavy Nasdaq entered a free-fall that has not yet found a bottom.

At the same time, that does not mean that we should abandon the sector as a lost cause. One such way to play the sector during its downhill slide is the exchange-traded fund (ETF) Direxion Daily Semiconductor Bear 3X Shares (NYSEARCA: SOXS).

As its title suggests, this is an inverse ETF, meaning that it is built to go up in value when its parent index goes down. Specifically, SOXS provides three times leveraged inverse exposure to a modified market-cap-weighted index of semiconductor companies that trade in American markets by using swap agreements, futures contracts and short positions.

While the index’s holdings are weighted by market capitalization, the fund’s managers cap the weights of the top five securities in the portfolio at 8% each. The weight of the remaining securities is capped at 4% each.

As of May 24, SOXS has been up 0.37% over the past month and up 24.73% for the past three months. It is currently up 60.47% year to date.

Chart courtesy of www.stockcharts.com

The fund has amassed $258.15 million in assets under management and has an expense ratio of 1.01%.

In short, while SOXS does provide an investor with a way to invest in an inverse ETF, this kind of ETF may not be appropriate for all portfolios. Thus, interested investors always should conduct their due diligence and decide whether the fund is suitable for their investing goals.

As always, I am happy to answer any of your questions about ETFs, so do not hesitate to send me an email. You just may see your question answered in a future ETF Talk.

The post Finding Shelter in an Inverse ETF appeared first on Stock Investor.

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