Results show that the shapes of the lithium plasma concentration versus time curves are similar to marketed product

ATLANTA–(BUSINESS WIRE)– Alzamend Neuro, Inc. (Nasdaq: ALZN) (“Alzamend”), an early clinical-stage biopharmaceutical company focused on developing novel products for the treatment of neurodegenerative diseases and psychiatric disorders, today announced that it has received the full data set from its Phase 1 clinical trial for AL001. The purpose of the Phase 1 first-in-human trial was to determine the pharmacokinetics, safety and tolerability of AL001. These data will help Alzamend establish doses for a planned Phase 2 multiple ascending dose study in Alzheimer’s disease (“Alzheimer’s”) patients. AL001 is a novel lithium-delivery system; it is a lithium-salicylate-L-proline engineered ionic cocrystal under development as an oral treatment for patients with dementia related to mild, moderate, and severe cognitive impairment associated with Alzheimer’s. AL001 has the potential to deliver benefits of marketed lithium carbonate without current toxicities.

It is difficult to set the appropriate dose of lithium carbonate and other lithium products due to the small margin between effective and toxic blood levels and to avoid side effects or inadequate treatment outcomes. Studies in mice showed advantageous site-of-action (brain) penetration and persistence of lithium (Via AL001) compared to lithium carbonate, indicating the possibility of reducing the lithium dose needed for efficacy, which could reduce potential side effects and reduce or eliminate blood level monitoring requirements.

The full data set builds upon topline data previously reported on December 21, 2021. These data affirmed that dose-adjusted relative bioavailability analyses of the rate and extent of lithium absorption in plasma indicate that AL001 at 150 mg dosage is bioequivalent to the marketed 300 mg lithium carbonate product and the shapes of the lithium plasma concentration versus time curves are similar. AL001 salicylate plasma concentrations were observed to be well tolerated and consistently within safe limits and the safety profiles of both AL001 and the marketed lithium carbonate capsule were benign.

During this Phase 1 trial, participants received a single dose of AL001 containing lithium in an amount equivalent to 150 mg lithium carbonate; at the dose proposed deemed appropriate for Alzheimer’s treatment when given three times daily. Currently, marketed lithium carbonate 300 mg are given three times daily when prescribed for manic episodes in bipolar disorder as well as maintenance therapy of bipolar disorder in patients with a history of manic episodes. Lithium is also prescribed off-label for major depression, often as an adjunct therapy, as well as for people with bipolar disorder without a history of mania, and treatment of post-traumatic stress disorder (“PTSD”).

“This is excellent news for the 3+ million Americans currently taking lithium-based treatments,” said Stephan Jackman, Chief Executive Officer of Alzamend. “We see the possibility of providing the benefits from AL001 containing lithium at up to 50% of the currently approved lithium carbonate dosage, with the potential for better outcomes and elimination of the need for lithium therapeutic drug monitoring. Moreover, the data confirm AL001’s potential as a replacement of the current lithium-based treatment and may provide a treatment to the over 40+ million Americans suffering from Alzheimer’s, Bipolar disorder, Depression and PTSD.”

Based on the Phase 1 results, it has been shown that dose-normalized bioequivalence for lithium was established between AL001 and the marketed reference lithium carbonate 300 mg capsule. AL001 was shown to be safe and well-tolerated in healthy adult subjects. AL001 salicylate exposures were within safe limits. No clinically significant abnormal findings in electrocardiograms were noted during the trial. No serious adverse events and no deaths were reported during the trial.

Findings of plasma bioequivalence to a marketed lithium product may allow Alzamend to reduce the scope or eliminate the need for Phase 2 and 3 studies of efficacy and/or safety of AL001 in such indications as bipolar/affective disorders in which lithium efficacy has been established. Bioequivalence may have utility for AL001 when seeking approval for the indications of currently marketed lithium products, and for new indications as a benchmark for safety.

Mr. Jackman added, “We look forward to swiftly initiating a Phase 2 multiple ascending dose study involving Alzheimer’s patients in the second quarter of 2022. Additionally, we look forward to pursuing investigational new drug applications with the United States Food and Drug Administration during 2022 for bipolar disorder, depression, and PTSD indications, and given the major unfilled public health need in these indications, we intend to seek expedited regulatory interaction.”

About AL001

AL001 is a patented ionic cocrystal technology delivering lithium via a therapeutic crystal-engineered combination of lithium, L-proline and salicylate, known as AL001 or LiProSal, through two royalty-bearing exclusive worldwide licenses from the University of South Florida Research Foundation, Inc.

Based on preclinical data, AL001 treatment prevents cognitive deficits, depression, and irritability in APPSWE/PS1dE9 mice, and has shown an improvement of associative learning and memory and irritability compared with lithium carbonate treatments, supporting the potential of this lithium formulation for the treatment of Alzheimer’s disease and psychiatric disorders. Lithium has been marketed for more than 35 years and human toxicology regarding lithium use has been well-characterized, potentially allowing Alzamend to rely upon this existing data, potentially reducing the regulatory burden for safety data.

About Alzamend Neuro

Alzamend Neuro is an early clinical-stage biopharmaceutical company focused on developing novel products for the treatment of neurodegenerative diseases and psychiatric disorders, including Alzheimer’s. Our mission is to rapidly develop and market safe and effective treatments. Our current pipeline consists of two novel therapeutic drug candidates, AL001 – a patented ionic cocrystal technology delivering lithium via a therapeutic combination of lithium, proline and salicylate, and AL002 – a patented method using a mutant-peptide sensitized cell as a cell-based therapeutic vaccine that seeks to restore the ability of a patient’s immunological system to combat Alzheimer’s. Both of our product candidates are licensed from the University of South Florida Research Foundation, Inc. pursuant to royalty-bearing exclusive worldwide licenses.

Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “believes,” “plans,” “anticipates,” “projects,” “estimates,” “expects,” “intends,” “strategy,” “future,” “opportunity,” “may,” “will,” “should,” “could,” “potential,” or similar expressions. Statements that are not historical facts are forward-looking statements. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties. Forward-looking statements speak only as of the date they are made, and Alzamend undertakes no obligation to update any of them publicly in light of new information or future events. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors. More information, including potential risk factors, that could affect Alzamend’s business and financial results are included in Alzamend’s filings with the U.S. Securities and Exchange Commission. All filings are available at www.sec.gov and on Alzamend’s website at www.Alzamend.com.

View source version on businesswire.com: https://www.businesswire.com/news/home/20220328005296/en/

Email: Info@Alzamend.com or call: 1-844-722-6333

Source: Alzamend Neuro, Inc.

Released March 28, 2022

Following completion of this initial study, Alzamend intends to initiate a Phase 1/2a clinical trial designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of AL001 in Alzheimer’s disease patients. Presuming favorable data, a subsequent Phase 2b program is planned to target appropriate doses for the pivotal Phase 3 safety/efficacy clinical program required for regulatory approval.

“This IND submission represents a key milestone for Alzamend as we continue to advance our proprietary pipeline. We believe AL001 could potentially provide clinicians with a major improvement over current lithium-based treatments and may constitute a means of treating Alzheimer’s disease and other neurodegenerative diseases and psychiatric disorders. We look forward to providing more details on the timeline and market opportunity following FDA clearance of the IND, if obtained,” commented Stephan Jackman, Chief Executive Officer of Alzamend.

Based on preclinical data, AL001 treatment prevents cognitive deficits, depression, and irritability in APPSWE/PS1dE9 mice, and has shown an improvement of associative learning and memory and irritability compared with lithium carbonate treatments, supporting the potential of this lithium formulation for the treatment of Alzheimer’s disease and psychiatric disorders. Lithium has been marketed for more than 35 years and human toxicology regarding lithium use has been well characterized, potentially allowing Alzamend to rely upon this existing data, potentially reducing the regulatory burden for safety data.

Alzamend’s mission is to help the Alzheimer’s disease community by supporting the full product development life cycle of treatment and cures for dementia and Alzheimer’s disease driven by the belief that strong support of research is the foundation for true innovation. Dementia is not a normal part of aging, and there are numerous symptoms that can indicate cognitive and neurological impairments. Alzheimer’s disease is the most common form of dementia. This disease robs people of their loved ones, as memories are erased and personalities are diminished. Alzamend’s vision statement nicely sums up their mission: “Together We Can ‘Make Alzheimer’s Just a Memory!’™”.

The economic impact of Alzheimer’s disease can be as devastating as the emotional stress. Over 47 million people in the world currently live with Alzheimer’s disease or dementia, with over 6.2 million in the U.S. (two-thirds are women). The lifetime cost of care for an Alzheimer’s disease patient is estimated at $374,000 in the U.S. According to the Alzheimer’s Association, it is estimated that Alzheimer’s and dementia deaths increased more than 16% in 2021 due to COVID-19. In 2021, Alzheimer’s and dementia will cost the U.S. an estimated $355 billion with the costs expected to rise into the trillions in the next 25 years. In, addition, Medicare and Medicaid is expected to pay approximately $239 billion, or 67% of the treatment and long-term care costs associated with Alzheimer’s disease and dementia, with another $79 billion of out-of-pocket costs. According to the Alzheimer’s Association, eleven million Americans provide an estimated 15.3 billion hours of unpaid care per year, valued at $257 billion, for these patients with two-thirds of these being women, and one-third being daughters.

About Alzamend Neuro

We are a preclinical stage biopharmaceutical company focused on developing novel products for the treatment of neurodegenerative diseases and psychiatric disorders, including Alzheimer’s disease. With our two current and future product candidates, we aim to bring treatments or cures to market at a reasonable cost as quickly as possible. Our current pipeline consists of two novel therapeutic drug candidates, AL001 – a patented ionic cocrystal technology delivering a therapeutic combination of lithium, proline and salicylate, and AL002 – a patented method using a mutant-peptide sensitized cell as a cell-based therapeutic vaccine that seeks to restore the ability of a patient’s immunological system to combat Alzheimer’s disease. Both of our product candidates are licensed from the University of South Florida Research Foundation, Inc. pursuant to royalty-bearing exclusive worldwide licenses.

Forward-Looking Statements

This press release contains “forward looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “believes,” “plans,” “anticipates,” “projects,” “estimates,” “expects,” “intends,” “strategy,” “future,” “opportunity,” “may,” “will,” “should,” “could,” “potential,” or similar expressions. Statements that are not historical facts are forward-looking statements. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties. Forward-looking statements speak only as of the date they are made, and Alzamend undertakes no obligation to update any of them publicly in light of new information or future events. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors. More information, including potential risk factors, that could affect Alzamend’s business and financial results are included in Alzamend’s filings with the U.S. Securities and Exchange Commission. All filings are available at www.sec.gov and on Alzamend’s website at www.AlzamendNeuro.com.

References:

1. Alzheimer’s Association. https://www.alz.org/alzheimers-dementia/facts-figures. . Accessed June 22, 2021.
2. Standard of Care: A Repository of Knowledge in the Field of Medicine. https://standardofcare.com/showarticle.php?artid=1231. Accessed June 22, 2021.

Spartan Capital Securities, LLC acted as the sole book-running manager for the public offering.

The offering was made only by means of a prospectus. Copies of the final prospectus are available on the Securities and Exchange Commission’s website at www.sec.gov and may be obtained from: Spartan Capital Securities, LLC, Attn.: Prospectus Department, 45 Broadway, 19th Floor, New York, NY 10006, by telephone at (212) 293-0123 or by email at investmentbanking@spartancapital.com.

The securities described above were offered by Alzamend pursuant to a registration statement on Form S-1 (File No. 333-255955) declared effective by the SEC on June 14, 2021. This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

Olshan Frome Wolosky LLP served as counsel to Alzamend Neuro and Haynes & Boone LLP represented the underwriter.

About Alzamend Neuro

We are a preclinical stage biopharmaceutical company focused on developing novel products for the treatment of neurodegenerative diseases and psychiatric disorders, including Alzheimer’s Disease (“AD”). With our two current and future product candidates, we aim to bring treatments or cures to market at a reasonable cost as quickly as possible. Our current pipeline consists of two novel therapeutic drug candidates, AL001 – a patented ionic cocrystal technology delivering a therapeutic combination of lithium, proline and salicylate, and AL002 – a patented method using a mutant-peptide sensitized cell as a cell-based therapeutic vaccine that seeks to restore the ability of a patient’s immunological system to combat AD.  Both of our product candidates are licensed from the University of South Florida Research Foundation, Inc. pursuant to royalty-bearing exclusive worldwide licenses.

Contacts

Email: Info@Alzamend.com or call: 1-844-722-6333