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ANEW MEDICAL to Advance Patented Klotho Gene Therapy for Neurodegenerative Disorder Treatments

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ANEW MEDICAL (NASDAQ: WENA) has announced plans to advance its patented Klotho gene therapy program aimed at treating neurodegenerative disorders such as ALS, Alzheimer’s, and Parkinson’s Disease. The company recently received patents in Europe, China, and Hong Kong, with patents pending in the U.S. and Canada. Initial data suggests elevated Klotho levels contribute to longer, healthier lifespans, while depleted levels increase susceptibility to these diseases. ANEW's strategy includes FDA clinical trials for CNS therapeutic delivery, development of Klotho diagnostics, and exploring gene therapies for age-related longevity. Collaborating with the Okinawa Research Center for Longevity Science, ANEW aims to leverage Klotho's role in longevity. Dr. Joseph Sinkule and Dr. Shalom Hirshman emphasize the potential of ANEW's platform technology to improve health and extend life expectancy.

Positive
  • ANEW MEDICAL granted patents in Europe, China, and Hong Kong.
  • Initial data shows elevated Klotho levels may extend lifespan and reduce susceptibility to neurodegenerative diseases.
  • Plans for FDA clinical trials to deliver Klotho gene therapy to CNS.
  • Development of Klotho diagnostics to quantify gene and protein levels in blood samples.
  • Exploratory approaches for promoting longevity using Klotho and other genes.
Negative
  • None.

Insights

The announcement by ANEW MEDICAL, INC. about advancing their patented Klotho gene therapy program for neurodegenerative disorders is particularly noteworthy for investors. The attainment of patents in multiple regions (Europe, China and Hong Kong) indicates strong international intellectual property protection, which could enhance the company's competitive position in the market. Patents act as barriers to entry for competitors and can lead to significant future revenue streams.

From a financial perspective, the news could lead to increased investor confidence, potentially driving up the stock price in the short term. Additionally, the announcement of future FDA clinical trials and diagnostic tools development indicates a well-rounded approach to market entry. Such diversification within the therapeutic and diagnostic domains can create multiple revenue opportunities, reducing overall business risk.

However, it's important to be aware of the typical high costs associated with clinical trials and the potential for delays due to regulatory approval processes. Investors should consider these factors when evaluating the long-term profitability of ANEW's ventures.

ANEW MEDICAL’s focus on Klotho gene therapy is compelling within the field of neurodegenerative disorder treatments. The initial data suggesting that elevated Klotho levels contribute to longer and healthier lives can have significant implications for treating a range of age-related disorders like ALS, Alzheimer's and Parkinson's Disease.

The involvement of the Okinawa Research Center for Longevity Science lends further credibility to the research, as their studies have identified Klotho as a critical factor in age-related longevity. This external validation is an essential component that bolsters the robustness of ANEW’s research claims.

However, while the initial data is promising, it is preliminary. The success of the therapy will depend on the outcomes of rigorous clinical trials. Investors should be cautious about overestimating the short-term impact until more definitive results are available.

The focus on developing diagnostics to accurately quantify Klotho levels introduces a dual revenue stream for ANEW MEDICAL. By providing a tool for healthcare providers to measure these levels, the company positions itself not only as a therapeutic developer but also as a valuable player in the diagnostic market. This dual approach can significantly enhance their market penetration and brand recognition.

Moreover, the innovative use of adenovirus (AAV) vectors for gene delivery suggests a forward-thinking approach that aligns with current advancements in genomic medicine. This could attract partnerships and collaborations, further strengthening ANEW’s market position.

Nonetheless, the diagnostic market is highly competitive and the success of these diagnostics hinges on their accuracy, ease of use and regulatory approval. Investors should watch for updates on these fronts to gauge the potential market impact accurately.

Genomics data suggests having an active Klotho gene sequence may help people live longer, healthier lives

The Company was granted patents in Europe, China, and Hong Kong and awaits issuance of patents in the U.S. and Canada

NEW YORK, July 09, 2024 (GLOBE NEWSWIRE) -- ANEW MEDICAL, INC. (NASDAQ: WENA) (“ANEW”), a biopharmaceutical company specializing in the advancement of novel disease-modifying therapies for neurological and age-related disorders, announces plans to advance its recently patented Klotho gene therapy program for neurodegenerative disorders.

ANEW has compelling initial data suggesting that maintaining elevated levels of Klotho in the body significantly contributes to longer, healthier lifespans. Conversely, the data reveals that individuals with depleted or lower-than-normal levels of Klotho are more susceptible to neurodegenerative disorders such as ALS, Alzheimer’s, and Parkinson’s Disease. ANEW will also investigate other age-related disorders associated with depleted Klotho levels, such as memory loss, osteoporosis, sarcopenia (muscle wasting), diabetes mellitus, and certain cardiovascular conditions.

Dr. Joseph Sinkule, CEO and Founder of ANEW MEDICAL, commented: “Administering a medication based on the Klotho isoform of interest, secreted Klotho (s-KL), may contribute to longer, healthier lives. Research by our strategic partner, the Okinawa Research Center for Longevity Science (ORCLS) in Japan, suggests that the Klotho gene is a key factor in age-related longevity. Klotho emerged as one of the two most significant genes from their studies, and we look forward to continuing our research with ORCLS as we advance ANEW’s clinical development programs for Neurodegenerative Disorders.”

ANEW has development plans to advance its program in three distinct areas:

  • FDA Clinical Trials: The development of therapeutics to treat neurodegenerative diseases and age-related disorders involves using an adenovirus (AAV) vector to deliver the secreted Klotho gene DNA sequence to neurons in the central nervous system (CNS). This approach aims to correct deficiencies in the levels of s-KL.
  • Klotho Diagnostics: The development and commercialization of a diagnostic that will enable healthcare providers to accurately quantify levels of Klotho gene and protein isoforms in blood samples. This tool will also provide ANEW with the necessary diagnostic to screen patients for its clinical trials.
  • Age-Related Disorders: ANEW plans to develop exploratory approaches to promote longevity in healthy populations using gene or cell-based Klotho therapies, as well as other genes of interest that are directly related to longevity.

Dr. Shalom Hirshman, M.D., Chief Medical Advisor and Board member, stated: “ANEW is in a strong position to significantly influence the treatment of ALS, Alzheimer’s, and other neurodegenerative disorders. With our patent-protected gene therapy platform technology, we have the potential to improve health and extend life expectancy.”

About ANEW MEDICAL, INC.:
ANEW MEDICAL is a biopharmaceutical company specializing in the advancement of novel disease-modifying therapies for neurological and age-related disorders. The company's focus on central nervous systems (CNS) diseases utilizing cell and gene therapies to mitigate age-related pathologies such as Alzheimer's disease, dementia symptoms and neuromuscular diseases. The Company has exclusive worldwide rights to develop and commercialize proprietary product platforms based on its proprietary isoform transcribed from the human Klotho gene referred to as secreted Klotho or "s-KL". This s-KL protein or gene therapy has been recognized for its potential to mitigate age-related pathologies such as ALS, Alzheimer's and Parkinson's Disease. The Company is also evaluating other core technology platforms to acquire for development and commercialization by the Company. For more information, please visit: www.anewmeds.com.

About Klotho:
Klotho is a gene that is integral to aging and cognitive function. The gene encodes two main protein variants: the full-length Klotho which is produced in the kidneys to regulate phosphate and calcium, and the secreted Klotho (s-KL) which is an RNA splice variant primarily synthesized in the brain. The s-KL variant is essential for maintaining normal brain and neurological functions. ANEW’s gene therapy program targeting klotho shows significant potential in treating age-related diseases like Amyotrophic Lateral Sclerosis (ALS), Alzheimer's Disease, and Parkinson's Disease. ANEW’s s-KL programs are advancing the use of Klotho as a target for gene and cell therapies, as well as in diagnostics for neurological and age-related disorders.

Forward-Looking Statements:
This press release contains forward-looking statements. These statements are made under the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements generally are identified by the words “believe,” “project,” “expect,” “anticipate,” “estimate,” “intend,” “strategy,” “future,” “opportunity,” “plan,” “may,” “should,” “will,” “would,” “will be,” “will continue,” “will likely result,” and similar expressions. Without limiting the generality of the foregoing, the forward-looking statements in this press release include descriptions of the Company’s future commercial operations. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. Many factors could cause actual future events to differ materially from the forward-looking statements in this press release, such as the Company’s inability to implement its business plans, identify and realize additional opportunities, or meet or exceed its financial projections and changes in the regulatory or competitive environment in which the Company operates. You should carefully consider the foregoing factors and the other risks and uncertainties described in the documents filed or to be filed by the Company with the U.S. Securities and Exchange Commission (the “SEC”) from time to time, which could cause actual events and results to differ materially from those contained in the forward-looking statements. Copies of these documents are available on the SEC’s website, www.sec.gov. All information provided herein is as of the date of this press release, and the Company undertakes no obligation to update any forward-looking statement, except as required under applicable law.

For more information, contact:
Investor Relations and Public Relations
Eric Boyd eric@anewmeds.com
or
PCG Advisory LLC.
Jeff Ramson or Adam Holdsworth
Email: ir@anewmeds.com
Website: www.anewmeds.com


FAQ

What is ANEW MEDICAL announcing in their recent press release?

ANEW MEDICAL is announcing plans to advance their patented Klotho gene therapy for treating neurodegenerative disorders such as ALS, Alzheimer’s, and Parkinson’s Disease.

Which patents has ANEW MEDICAL received for their Klotho gene therapy?

ANEW MEDICAL has received patents in Europe, China, and Hong Kong for their Klotho gene therapy, with patents pending in the U.S. and Canada.

How does the Klotho gene therapy potentially benefit patients?

Initial data suggests that maintaining elevated levels of Klotho can lead to longer, healthier lifespans and reduce susceptibility to neurodegenerative disorders such as ALS, Alzheimer’s, and Parkinson’s Disease.

What are ANEW MEDICAL's development plans for Klotho gene therapy?

ANEW MEDICAL plans to advance Klotho gene therapy through FDA clinical trials, develop Klotho diagnostics, and explore Klotho-based therapies for promoting longevity.

What is the stock symbol for ANEW MEDICAL?

The stock symbol for ANEW MEDICAL is WENA.

ANEW MEDICAL, INC.

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Biotechnology
Biological Products, (no Disgnostic Substances)
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United States of America
NEW YORK