| The lead candidate, AL001, is a patented ionic cocrystal technology that delivers lithium through a combination of lithium, proline, and salicylate.
This formulation is being developed for the treatment of Alzheimer’s disease, BD, MDD, and PTSD.
Preclinical studies of AL001 demonstrated its ability to prevent cognitive deficits, depression, and irritability in animal models, showing superior efficacy in improving learning, memory, and irritability compared to traditional lithium carbonate treatments.
The first-in-human Phase I clinical trial for AL001 began in September 2021, with topline data reported in December 2021 and a full data set released in March 2022. Results indicated that AL001 at a 150 mg dosage is bioequivalent to the marketed 300 mg lithium carbonate product, with similar plasma concentration profiles and well-tolerated safety margins.
A Phase II multiple-ascending dose study in Alzheimer’s patients was initiated in May 2022 and completed its clinical phase in March 2023, with topline results announced in June 2023.
Additionally, the U.S. Food and Drug Administration (FDA) provided guidance in late 2023 for additional indications for Alzamend’s clinical development of AL001 for treatment of BD, MDD, and PTSD, noting that lithium’s long-standing use and well-characterized toxicology may help streamline regulatory requirements.
Alzamend’s second candidate, ALZN002, represents a proprietary “active” immunotherapy approach.
This personalized/patient specific therapy uses autologous dendritic cells from each patient, engineered ex vivo to target Alzheimer’s-related amyloid-beta proteins.
The aim is to stimulate the immune system to reduce beta-amyloid burden in the brain, thereby alleviating Alzheimer’s symptoms.
In October 2022, the FDA authorized a Phase I/IIA clinical trial for ALZN002 in patients with mild to moderate Alzheimer’s dementia, and a trial was initiated in March 2023.
Alzamend’s work is set against the backdrop of a growing Alzheimer’s crisis. Alzheimer’s disease is the seventh leading cause of death in the United States, affecting approximately 6.2Mn Americans—a number projected to rise to 13Mn by 2050.
The economic burden is immense, with annual healthcare costs estimated at $345Bn in 2023 and projected to reach $1.1Tn by 2050 without effective treatments or a cure.
Through its innovative pipeline and commitment to research, Alzamend Neuro aims to transform the landscape of Alzheimer’s and psychiatric disorder treatment, providing hope for millions of patients and their families.
Grab Sources And More: ALZN Website. ALZN Presentation. -----
And based on several potential catalysts, (Nasdaq: ALZN) could start earning some serious buzz. Check these out:
No. 1 ALZN Potential Catalyst - Could An Extremely Low Float Create An Environment For Heightened Volatility?
According to the MarketWatch website, ALZN has an extremely low float.
In fact, the website reports this profile has approximately 767.17k shares in its float.
Why is that important? It's important on one crucial level. Volatility potential.
If the company provides more positive company news in the first half of 2025, could it create a near term spark? -----
No. 2 ALZN Potential Catalyst - An Analyst Target Suggests ALZN Could Be Significantly Undervalued.
On March 15th of this year, an analyst with Ascendiant Capital Markets tagged ALZN with a $20 target.
At the time of announcing the $20 target, ALZN was trading around $.68 (before the company's reverse split on 5/8).
That means the analyst was suggesting ALZN may have had over 2,800% potential upside at the time!
Check out the complete analyst report. -----
No. 3 ALZN Potential Catalyst - ALZN Announced First Patient Enrolled In Key Phase II Clinical Trial.
Alzamend Neuro Enrolls First Patient in its Phase II Clinical Trial of AL001 “Lithium in Brain” Study Taking Place at Massachusetts General Hospital
- Topline data expected by year end
- Head-to-head studies of AL001 versus a marketed lithium carbonate product will be conducted for comparisons of lithium blood and brain/brain-structure pharmacokinetics in healthy subjects
ATLANTA, May 19, 2025 (GLOBE NEWSWIRE) -- Alzamend Neuro, Inc. (Nasdaq: ALZN) (“Alzamend”), ..., today announced the enrollment of the first patient of its first Phase II clinical study of AL001, in healthy human subjects. This study follows the successful development of a novel head coil by Tesla Dynamic Coils BV, a key component of the clinical trial.
In collaboration with Massachusetts General Hospital as its clinical trial site, Alzamend aims to explore the unique properties of AL001 and its potential to deliver lithium more effectively in the brain compared to marketed lithium salts. The study in healthy human subjects will serve as a baseline and assist Alzamend determine the best path forward in Alzheimer’s, BD, MDD and PTSD patients by demonstrating AL001’s targeted effectiveness and reduced systemic side effects. Previous studies in mice have shown that AL001 ensures better brain absorption while maintaining lower levels of lithium in the blood, paving the way for safer and more efficient treatments.
By offering a treatment that potentially eliminates the need for lithium therapeutic drug monitoring (“TDM”), AL001 could revolutionize care for vulnerable patient populations and improve treatment outcomes. Lithium, renowned for its efficacy as a first-line therapy for manic episodes and maintenance in BD, has long been underutilized due to the complexities of TDM. Current U.S. Food and Drug Administration-approved lithium salts are limited by a narrow therapeutic window that requires regular TDM of plasma lithium levels and blood chemistry by a clinician to mitigate adverse events. Since conventional lithium salts are eliminated relatively quickly, multiple administrations throughout the day are required to safely reach therapeutic plasma concentrations. By reducing the systemic burden, Alzamend’s novel AL001 formulation could signify a major shift in managing conditions like Alzheimer’s, by minimizing risks associated with kidney and thyroid side effects traditionally linked to lithium therapies.
“We are pleased to announce the enrollment of the first patient in our clinical study evaluating AL001, with topline data anticipated by the end of the year,” stated Stephan Jackman, Chief Executive Officer of Alzamend. “AL001 has the potential to transform the treatment landscape for over 43Mn Americans affected by Alzheimer’s, BD, MDD and PTSD. By offering improved safety, enhanced central nervous system targeting, and eliminating the requirement for TDM, AL001 aims to address significant limitations of current lithium therapies and advance patient care, with the goal of improving both treatment efficacy and quality of life.”
Read the full article here. -----
No. 4 ALZN Potential Catalyst - A Partnership With A Leading Medical Imaging AI Company Could Prove Game-Changing For ALZN.
Alzamend Neuro Partners with QMENTA, to Advance AI-Powered Imaging for its Phase II Clinical Trial of AL001 Study to Take Place at Massachusetts General Hospital
- Head-to-head studies of AL001 versus a marketed lithium carbonate product will be conducted for comparisons of lithium blood and brain/brain-structure pharmacokinetics in healthy subjects
ATLANTA, May 07, 2025 (GLOBE NEWSWIRE) -- Alzamend Neuro, Inc. (Nasdaq: ALZN) (“Alzamend”), ..., today announced its partnership with Mint Labs Inc. d/b/a QMENTA (“QMENTA”), a leading medical imaging artificial intelligence (“AI”) company, to support its five upcoming Phase II clinical trials of AL001 at Massachusetts General Hospital.
QMENTA’s cloud-based platform will manage and analyze medical imaging data throughout the trials, ensuring regulatory compliance, enhancing operational efficiency and supporting data management. Their advanced AI solutions will play a critical role in optimizing the imaging workflow across all five clinical studies.
In collaboration with QMENTA and Massachusetts General Hospital as its clinical trial site, Alzamend aims to explore the unique properties of AL001 and its potential to deliver lithium more effectively in the brain compared to marketed lithium salts. The study in healthy human subjects will serve as a baseline and assist Alzamend determine the best path forward in Alzheimer’s, BD, MDD and PTSD patients by demonstrating AL001’s targeted effectiveness and reduced systemic side effects. Previous studies in mice have shown that AL001 ensures better brain absorption while maintaining lower levels of lithium in the blood, paving the way for safer and more efficient treatments.
...
“QMENTA has developed an all-in-one management platform for medical imaging clinical trials incorporating advancing AI solutions,” said Stephan Jackman, Chief Executive Officer of Alzamend. “We are thrilled to add QMENTA to the team and have full confidence in their ability encompassing our five phase II clinical studies of AL001. Moreover, this collaboration lays a foundation for future phase III programs and broader clinical deployment of advanced AI-based imaging biomarkers.”
...
Read the full article here. -----
No. 5 ALZN Potential Catalyst - Multiple Oversold Leaning Technicals Could Suggest Strong Reversal Potential.
At 4:00PM EST Wednesday, Barchart was reporting ALZN to have several oversold leaning technical indicators.
These technicals could be signaling a healthy reversal is approaching in the near term.
Here's the definition of a "reversal" from Investopedia:
"A reversal is a change in the price direction of an asset. A reversal can occur to the upside or downside. Following an uptrend, a reversal would be to the downside. Following a downtrend, a reversal would be to the upside. Reversals are based on overall price direction and are not typically based on one or two periods/bars on a chart."
Here's the technicals to pay close attention to (as of 4:00PM EST Wednesday):
- 9-Day Relative Strength Index: 26.82%
- 14-Day Relative Strength Index: 28.39%
When these numbers drop down to the 30% range and lower, they can be viewed as being in oversold territory. While in this territory, they can paint the picture of a profile that is undervalued.
- 14-Day Raw Stochastic: 8.25%
- 14-Day Williams %R: 91.75%
As the Raw Stochastic nears the 10% range and lower and the Williams %R nears the 90% range or higher, these technical indicators may also be viewed as oversold and undervalued.
Keep an eye on these technicals closely. -----
(Nasdaq: ALZN) Recap - 5 Potential Catalysts Lead The Way
No. 1 - Could An Extremely Low Float Create An Environment For Heightened Volatility?
No. 2 - An Analyst Target Suggests ALZN Could Be Significantly Undervalued.
No. 3 - ALZN Announced First Patient Enrolled In Key Phase II Clinical Trial.
No. 4 - A Partnership With A Leading Medical Imaging AI Company Could Prove Game-Changing For ALZN.
No. 5 - Multiple Oversold Leaning Technicals Could Suggest Strong Reversal Potential. -----
Coverage is officially initiated on Alzamend Neuro, Inc. (Nasdaq: ALZN).
I'll be in touch with updates when necessary. Talk soon.
Sincerely, Kai Parker StockWireNews
(Always Remember The St-ock Prices Could Be Significantly Lower Now From The Dates I Provided.)
*StockWireNews.com (“StockWireNews” or “SWN” ) is owned by SWN Media LLC, a single member limited liability company. Data is provided from third-party sources and SWN is not responsible for its accuracy. Make sure to always do your own research and due diligence on any day and swing profile SWN brings to your attention. Any emojis used do not have a specific defined meaning, and may be used inconsistently. We do not provide personalized in-vest-ment advice, are not in-vest-ment advisors, and any profiles we mention are not suitable for all in-vest-ors.
Pursuant to an agreement between SWN Media LLC and TD Media LLC, SWN Media LLC has been hired for a period beginning on 05/29/2025 and ending on 05/29/2025 to publicly disseminate information about (ALZN:US) via digital communications. Under this agreement, SWN Media LLC has been paid seventeen thousand five hundred USD (“Funds”). These Funds were part of the funds that TD Media LLC received from Alzamend Neuro Inc., the issuer of (ALZN:US).
Neither SWN Media LLC, TD Media LLC and their member own shares of (ALZN:US).
Please see important disclosure information here: https://stockwirenews.com/disclosure/alzn-foqsa/#details | 
Tidak ada komentar:
Posting Komentar