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Miami Herald
03-07-2025
- Business
- Miami Herald
MIRA Reports Potent Inflammatory Pain Relief from Non-Psychoactive Marijuana Analog Mira-55 in Animal Model, Matching Morphine Without Opioid Risks
With Mira-55 and Ketamir-2, MIRA is advancing complementary non-opioid therapies for two of the largest pain markets MIAMI, FLORIDA / ACCESS Newswire / July 3, 2025 / MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA) ("MIRA" or the "Company"), a clinical-stage pharmaceutical company developing novel therapeutics for neurologic, neuropsychiatric, and metabolic disorders, today announced positive preclinical data demonstrating that Mira-55, the Company's proprietary non-psychotropic marijuana analog, delivered morphine-comparable pain relief in a validated model of inflammatory pain-without causing local inflammation. Mira-55 is a next-generation analog of marijuana, engineered to selectively activate CB2 cannabinoid receptors, which are associated with anti-inflammatory and analgesic effects. Unlike THC, Mira-55 minimizes activation of CB1 receptors, reducing the risk of euphoria, sedation, and pro-inflammatory side effects. "These results reinforce the value of Mira-55 as a differentiated cannabinoid-based therapy with real clinical potential," said Erez Aminov, Chairman and CEO of MIRA. "We believe the drug's ability to match morphine's pain relief-without the baggage of addiction, sedation, or THC-like effects-makes Mira-55 an ideal candidate for large, underserved inflammatory pain markets. It's another step in building a non-opioid pain franchise that addresses both inflammatory and neuropathic pain." Study Overview and Key Findings Mira-55 was tested using the formalin model, a gold-standard preclinical method for studying inflammatory pain. In this model, formalin is injected into the rat's paw, producing a pain response that mimics human inflammatory pain. Pain sensitivity was assessed using Von Frey Filament testing, which measures tactile pain thresholds, and inflammation was measured by paw edema volume. Key findings: Mira-55 reduced pain sensitivity by approximately threefold, restoring thresholds to near-baseline analgesic effect was equivalent to morphine, the standard opioid comparator in the sedation or inflammatory swelling was observed with Mira-55 treatment. Importantly, following a scientific review, the U.S. Drug Enforcement Administration (DEA) determined that Mira-55 is not classified as a controlled substance. This designation supports the compound's long-term clinical and commercial viability and removes key barriers typically associated with cannabinoid-based drug development. These results build on prior data from a separate inflammatory pain model conducted by a leading U.S. academic research center, where Mira-55 blocked both thermal and mechanical hyperalgesia without increasing inflammation. In contrast, low-dose THC in that model exacerbated inflammation-further validating Mira-55's selective pharmacological profile. "Mira-55 offers the pain-relieving potential of cannabinoids without the liabilities traditionally seen in THC-based drugs," said Dr. Itzchak Angel, Chief Scientific Advisor at MIRA. "Its novel structure and unique profile with CB2 selectivity and non-scheduled DEA status make it a compelling candidate for treating inflammation-driven pain conditions that are poorly managed by today's standards." Strategic Fit Within MIRA's Pain Portfolio Mira-55 complements Ketamir-2, MIRA's clinical-stage NMDA receptor antagonist, which is advancing through Phase 1 development for neuropathic pain. While Ketamir-2 addresses nerve-related pain through central mechanisms, Mira-55 targets inflammatory pain through the endocannabinoid system. Together, they represent two mechanistically distinct, non-opioid approaches to treating chronic pain. "With Mira-55 and Ketamir-2, we now have two highly differentiated drug candidates with the potential to transform how inflammatory and neuropathic conditions are treated," added Aminov. "We're advancing each asset methodically, and we're energized by the momentum we've built across the pipeline." Corporate Update on SKNY Merger MIRA also announced continued progress on its previously disclosed acquisition of SKNY Pharmaceuticals, the developer of SKNY-1, a novel investigational therapy targeting both obesity and nicotine addiction. In recent studies, SKNY-1 demonstrated a 30% reduction in body weight without muscle loss, along with a reversal of nicotine cravings-highlighting its potential as a differentiated treatment in two major markets. The U.S. Securities and Exchange Commission (SEC) has completed its review of the merger proxy with no comments, allowing MIRA to proceed with shareholder approval and the final steps toward completing the transaction. "We are pleased to report that the SEC had no comments on our merger filing, which reflects the quality of our regulatory and business preparation," said Aminov. "This milestone allows us to advance toward shareholder approval with clarity and confidence as we prepare for the next phase of growth." Next Steps MIRA Pharmaceuticals is advancing Mira-55 toward an Investigational New Drug (IND) submission, with ongoing activities supporting future clinical development in inflammatory pain. The Company remains focused on progressing both lead programs-Mira-55 and Ketamir-2-toward their next regulatory and clinical milestones. About MIRA Pharmaceuticals, Pharmaceuticals, Inc. (NASDAQ:MIRA) is a clinical-stage pharmaceutical company focused on the development and commercialization of novel therapeutics for neurologic, neuropsychiatric, and metabolic disorders. The Company's pipeline includes oral drug candidates designed to address significant unmet medical needs in areas such as neuropathic pain, inflammatory pain, obesity, addiction, anxiety, and cognitive decline. Cautionary Note Regarding Forward-Looking StatementsThis press release and the statements of MIRA's management related thereto contain "forward-looking statements," which are statements other than historical facts made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These statements may be identified by words such as "aims," "anticipates," "believes," "could," "estimates," "expects," "forecasts," "goal," "intends," "may," "plans," "possible," "potential," "seeks," "will," and variations of these words or similar expressions that are intended to identify forward-looking statements. Any statements in this press release that are not historical facts may be deemed forward-looking. Any forward-looking statements in this press release are based on MIRA's current expectations, estimates, and projections only as of the date of this release and are subject to a number of risks and uncertainties (many of which are beyond MIRA's control) that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements, including related to MIRA's potential merger with SKNY Pharmaceuticals, Inc. These and other risks concerning MIRA's programs and operations are described in additional detail in the Annual Report on Form 10-K for the year ended December 31, 2024, and the Form 14A filed by MIRA on June 18, 2025, and other SEC filings, which are on file with the SEC at and on MIRA's website at MIRA explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law. Contact:Helga Moyainfo@ 432-9792 SOURCE: MIRA Pharmaceuticals
USA Today
03-07-2025
- Business
- USA Today
MIRA Reports Potent Inflammatory Pain Relief from Non-Psychoactive Marijuana Analog Mira-55 in Animal Model, Matching Morphine Without Opioid Risks
With Mira-55 and Ketamir-2, MIRA is advancing complementary non-opioid therapies for two of the largest pain markets MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA) ('MIRA' or the 'Company'), a clinical-stage pharmaceutical company developing novel therapeutics for neurologic, neuropsychiatric, and metabolic disorders, today announced positive preclinical data demonstrating that Mira-55, the Company's proprietary non-psychotropic marijuana analog, delivered morphine-comparable pain relief in a validated model of inflammatory pain-without causing local inflammation. Mira-55 is a next-generation analog of marijuana, engineered to selectively activate CB2 cannabinoid receptors, which are associated with anti-inflammatory and analgesic effects. Unlike THC, Mira-55 minimizes activation of CB1 receptors, reducing the risk of euphoria, sedation, and pro-inflammatory side effects. 'These results reinforce the value of Mira-55 as a differentiated cannabinoid-based therapy with real clinical potential,' said Erez Aminov, Chairman and CEO of MIRA. 'We believe the drug's ability to match morphine's pain relief-without the baggage of addiction, sedation, or THC-like effects-makes Mira-55 an ideal candidate for large, underserved inflammatory pain markets. It's another step in building a non-opioid pain franchise that addresses both inflammatory and neuropathic pain.' Study Overview and Key Findings Mira-55 was tested using the formalin model, a gold-standard preclinical method for studying inflammatory pain. In this model, formalin is injected into the rat's paw, producing a pain response that mimics human inflammatory pain. Pain sensitivity was assessed using Von Frey Filament testing, which measures tactile pain thresholds, and inflammation was measured by paw edema volume. Key findings: Mira-55 reduced pain sensitivity by approximately threefold, restoring thresholds to near-baseline levels. Its analgesic effect was equivalent to morphine, the standard opioid comparator in the study. No sedation or inflammatory swelling was observed with Mira-55 treatment. Importantly, following a scientific review, the U.S. Drug Enforcement Administration (DEA) determined that Mira-55 is not classified as a controlled substance. This designation supports the compound's long-term clinical and commercial viability and removes key barriers typically associated with cannabinoid-based drug development. These results build on prior data from a separate inflammatory pain model conducted by a leading U.S. academic research center, where Mira-55 blocked both thermal and mechanical hyperalgesia without increasing inflammation. In contrast, low-dose THC in that model exacerbated inflammation-further validating Mira-55's selective pharmacological profile. 'Mira-55 offers the pain-relieving potential of cannabinoids without the liabilities traditionally seen in THC-based drugs,' said Dr. Itzchak Angel, Chief Scientific Advisor at MIRA. 'Its novel structure and unique profile with CB2 selectivity and non-scheduled DEA status make it a compelling candidate for treating inflammation-driven pain conditions that are poorly managed by today's standards.' Strategic Fit Within MIRA's Pain Portfolio Mira-55 complements Ketamir-2, MIRA's clinical-stage NMDA receptor antagonist, which is advancing through Phase 1 development for neuropathic pain. While Ketamir-2 addresses nerve-related pain through central mechanisms, Mira-55 targets inflammatory pain through the endocannabinoid system. Together, they represent two mechanistically distinct, non-opioid approaches to treating chronic pain. 'With Mira-55 and Ketamir-2, we now have two highly differentiated drug candidates with the potential to transform how inflammatory and neuropathic conditions are treated,' added Aminov. 'We're advancing each asset methodically, and we're energized by the momentum we've built across the pipeline.' Corporate Update on SKNY Merger MIRA also announced continued progress on its previously disclosed acquisition of SKNY Pharmaceuticals, the developer of SKNY-1, a novel investigational therapy targeting both obesity and nicotine addiction. In recent studies, SKNY-1 demonstrated a 30% reduction in body weight without muscle loss, along with a reversal of nicotine cravings-highlighting its potential as a differentiated treatment in two major markets. The U.S. Securities and Exchange Commission (SEC) has completed its review of the merger proxy with no comments, allowing MIRA to proceed with shareholder approval and the final steps toward completing the transaction. 'We are pleased to report that the SEC had no comments on our merger filing, which reflects the quality of our regulatory and business preparation,' said Aminov. 'This milestone allows us to advance toward shareholder approval with clarity and confidence as we prepare for the next phase of growth.' Next Steps MIRA Pharmaceuticals is advancing Mira-55 toward an Investigational New Drug (IND) submission, with ongoing activities supporting future clinical development in inflammatory pain. The Company remains focused on progressing both lead programs-Mira-55 and Ketamir-2-toward their next regulatory and clinical milestones. About MIRA Pharmaceuticals, Inc. MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA) is a clinical-stage pharmaceutical company focused on the development and commercialization of novel therapeutics for neurologic, neuropsychiatric, and metabolic disorders. The Company's pipeline includes oral drug candidates designed to address significant unmet medical needs in areas such as neuropathic pain, inflammatory pain, obesity, addiction, anxiety, and cognitive decline. Cautionary Note Regarding Forward-Looking Statements This press release and the statements of MIRA's management related thereto contain 'forward-looking statements,' which are statements other than historical facts made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These statements may be identified by words such as 'aims,' 'anticipates,' 'believes,' 'could,' 'estimates,' 'expects,' 'forecasts,' 'goal,' 'intends,' 'may,' 'plans,' 'possible,' 'potential,' 'seeks,' 'will,' and variations of these words or similar expressions that are intended to identify forward-looking statements. Any statements in this press release that are not historical facts may be deemed forward-looking. Any forward-looking statements in this press release are based on MIRA's current expectations, estimates, and projections only as of the date of this release and are subject to a number of risks and uncertainties (many of which are beyond MIRA's control) that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements, including related to MIRA's potential merger with SKNY Pharmaceuticals, Inc. These and other risks concerning MIRA's programs and operations are described in additional detail in the Annual Report on Form 10-K for the year ended December 31, 2024, and the Form 14A filed by MIRA on June 18, 2025, and other SEC filings, which are on file with the SEC at and on MIRA's website at MIRA explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law. Contact: Helga Moya info@ (786) 432-9792 SOURCE: MIRA Pharmaceuticals View the original press release on ACCESS Newswire
Miami Herald
25-06-2025
- Business
- Miami Herald
MIRA Pharmaceuticals Announces New Data Underscoring Potential of SKNY-1 - A Drug Candidate Pending Acquisition - To Disrupt Weight Loss and Smoking Cessation Markets Without CNS Side Effects
MIAMI, FL / ACCESS Newswire / June 25, 2025 / MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA) ("MIRA" or the "Company"), a clinical-stage pharmaceutical company focused on developing novel therapeutics for neurologic, neuropsychiatric, and metabolic disorders, today announced new in vitro preclinical data generated by Eurofins supporting the therapeutic potential of SKNY-1, a next-generation oral drug candidate being developed by SKNY Pharmaceuticals, Inc. ("SKNY"). MIRA has signed a definitive agreement to acquire SKNY, and the proposed transaction remains subject to regulatory review and shareholder approval. SKNY-1 is being developed to help individuals lose weight and quit smoking by targeting key biological pathways involved in appetite, addiction, and reward-without triggering the central nervous system (CNS) side effects that have historically limited cannabinoid-based therapies. "We believe SKNY-1 could be a first-in-class oral therapy for two of the largest and most underserved markets: obesity and nicotine addiction," said Erez Aminov, CEO of MIRA. "What makes this drug candidate so exciting is its precision-it's engineered to avoid the psychiatric side effects that doomed earlier drugs in this class, while offering a safe, convenient, once-daily oral option." Designed for Selectivity and SafetyPrevious CB1-targeting drugs, such as rimonabant (Acomplia®, Sanofi), showed weight loss and metabolic results but were ultimately withdrawn from the market due to serious psychiatric side effects, including depression and suicidal ideation.¹ These effects stemmed from non-selective inhibition of CB1 signaling in the brain. In contrast, in vitro studies conducted by Eurofins demonstrated that SKNY-1 acts as a biased CB1 modulator-selectively blocking the β-arrestin signaling pathway, which is associated with cravings and compulsive behavior, while preserving G-protein signaling, which is important for emotional and cognitive stability. This selective mechanism is designed to reduce cravings and body weight without disrupting mood. A Dual Receptor Strategy-Engaging CB2 for Metabolic SupportIn addition to CB1 modulation, SKNY-1 also interacts with the CB2 receptor, which plays a critical role in metabolic regulation and inflammation. Eurofins' in vitro data show that SKNY-1 behaves as a partial CB2 agonist, potentially enhancing fat metabolism, reducing peripheral inflammation and improving insulin sensitivity. This dose-dependent flexibility distinguishes SKNY-1 from earlier CB1-only drugs and may enable a broader therapeutic impact on obesity-related pathways. "SKNY-1 combines modern pharmacology with real-world practicality," said Dr. Itzchak Angel, Chief Scientific Advisor at MIRA. "By precisely modulating CB1 and CB2 and supporting dopamine stability, it targets obesity and addiction through multiple, complementary mechanisms while potentially avoiding cannabinoid-related psychiatric side-effects." Dopamine Stability Without Stimulant RiskSKNY-1 also mildly inhibits the MAO-B enzyme, helping regulate dopamine, a neurotransmitter involved in motivation, focus, and reward. Unlike older monoamine inhibitors, SKNY-1 does not inhibit MAO-A, reducing the risk of serotonin-related side effects. Importantly, the compound demonstrated no or minimal antagonist binding to dopamine receptors (D1, D2, D3), further supporting its favorable CNS safety profile. A Differentiated Alternative to InjectablesWhile injectable GLP-1 drugs have gained market attention, they are often associated with gastrointestinal side effects and muscle loss. SKNY-1 is being developed as an oral therapy with a profile and expected mechanism that may help preserve muscle mass and improve patient adherence by avoiding injections. Market Outlook and Strategic FitObesity and smoking remain two of the world's leading causes of preventable death. The global obesity drug market is projected to surpass $150 billion in value by 2030, and the U.S. smoking cessation market is forecast to grow from $28 billion in 2024 to over $50 billion by decade's end. Pending the completion of the proposed acquisition, MIRA believes SKNY-1 could become a cornerstone asset within its pipeline, offering a next-generation solution to two major health challenges. The Company is currently finalizing animal data related to weight loss and nicotine addiction, which will further support its development strategy and future regulatory filings. MIRA has submitted the required regulatory filings to the U.S. Securities and Exchange Commission (SEC) in connection with the proposed acquisition of SKNY. A shareholder vote will follow in accordance with SEC regulations. For more information, please visit: About MIRA Pharmaceuticals, Pharmaceuticals, Inc. (NASDAQ:MIRA) is a clinical-stage pharmaceutical company focused on the development and commercialization of novel therapeutics for neurologic, neuropsychiatric, and metabolic disorders. The Company's pipeline includes oral drug candidates designed to address significant unmet medical needs in areas such as anxiety, cognitive decline, neuropathic pain, obesity, and addiction. Cautionary Note Regarding Forward-Looking StatementsThis press release and the statements of MIRA's management related thereto contain "forward-looking statements," which are statements other than historical facts made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These statements may be identified by words such as "aims," "anticipates," "believes," "could," "estimates," "expects," "forecasts," "goal," "intends," "may," "plans," "possible," "potential," "seeks," "will," and variations of these words or similar expressions that are intended to identify forward-looking statements. Any statements in this press release that are not historical facts may be deemed forward-looking. Any forward-looking statements in this press release are based on MIRA's current expectations, estimates, and projections only as of the date of this release and are subject to a number of risks and uncertainties (many of which are beyond MIRA's control) that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements, including related to MIRA's potential merger with SKNY Pharmaceuticals, Inc. These and other risks concerning MIRA's programs and operations are described in additional detail in the Annual Report on Form 10-K for the year ended December 31, 2024, and the Form 14A filed by MIRA on June 18, 2025, and other SEC filings, which are on file with the SEC at and MIRA's website at MIRA explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law. Footnote:¹ European Medicines Agency. "Acomplia Suspended as Risks Outweigh Benefits." October 23, 2008. CONTACT:Helga Moyainfo@ 432-9792 SOURCE: MIRA Pharmaceuticals
Miami Herald
18-06-2025
- Business
- Miami Herald
MIRA Pharmaceuticals' Lead Drug Candidate Ketamir-2 First Manuscript Accepted for Publication in the Peer-Reviewed Journal Frontiers in Pharmacology
MIAMI, FL / ACCESS Newswire / June 18, 2025 / MIRA Pharmaceuticals, Inc. (Nasdaq:MIRA) ("MIRA" or the "Company"), a clinical-stage pharmaceutical company developing novel therapeutics for neurologic, neuropsychiatric, and metabolic disorders, today announced that the first manuscript describing its lead drug candidate Ketamir-2, currently being evaluated in an ongoing Phase 1 clinical trial for neuropathic pain, has been accepted for publication in the peer-reviewed journal Frontiers in Pharmacology. The article, titled "KETAMIR-2, A NEW MOLECULAR ENTITY AND NOVEL KETAMINE ANALOG," authored by Itzchak Angel, Ph.D., MIRA's Chief Scientific Advisor, highlights Ketamir-2's pharmacological differentiation from ketamine and its potential as a next-generation CNS therapeutic. Peer Review Validates Differentiated Pharmacology and Safety Acceptance into Frontiers in Pharmacology provides external scientific validation by independent experts, underscoring the rigor and credibility of MIRA's research. The publication confirms that Ketamir-2 was specifically engineered to overcome limitations associated with ketamine-such as poor oral bioavailability, dissociative side effects, and non-specific receptor binding. Key Highlights from the Publication: Highly Selective, Cleaner Mechanism: Ketamir-2 is a low-affinity NMDA receptor antagonist that selectively targets the NMDA PCP site. Unlike ketamine, Ketamir-2 showed no significant interaction with over 40 other receptors, transporters, or ion channel targets-including dopamine, opioid, serotonin, and monoaminergic systems-highlighting its clean pharmacological profile and reduced off-target Hyperlocomotion, Even at High Doses: In contrast to ketamine, Ketamir-2 did not induce hyperlocomotion in preclinical models-a behavior associated with agitation and schizophrenia-like symptoms-suggesting a favorable neurobehavioral safety Antidepressant and Anxiolytic Activity: In validated behavioral models (Open Field Test, Elevated Plus Maze, Forced Swim Test), Ketamir-2 demonstrated clear anxiolytic and antidepressant-like effects. Ketamine, used as a control, either showed no benefit or limited effect in most Delivery with Efficient Brain Penetration: All studies were conducted via the oral route. Ketamir-2 was shown to cross the blood-brain barrier and is not a substrate for P-glycoprotein, which often limits oral drug delivery to the brain. This may explain Ketamir-2's ability to maintain CNS activity despite its lower NMDA receptor affinity. "We are honored to see our foundational research on Ketamir-2 published in a high-impact scientific journal," said Erez Aminov, CEO of MIRA. "This milestone adds meaningful scientific credibility and supports our confidence in Ketamir-2's differentiated mechanism, favorable safety profile, and broad clinical potential." "This peer-reviewed publication provides clear validation of the differentiated pharmacological profile of Ketamir-2," added Dr. Itzchak Angel, Chief Scientific Advisor. "Its clean pharmacological profile and safety make it a compelling next-generation alternative to ketamine." Clinical and Corporate Updates MIRA also announced that its Phase 1 trial of Ketamir-2 is progressing as planned, with no safety concerns reported to date and dose escalation advancing. The Company expects to initiate a Phase 2a clinical trial in neuropathic pain by year-end 2025, pending regulatory clearance. In addition, the Company is preparing new scientific data submissions and presentations to further support Ketamir-2's clinical development and potential across CNS-related conditions. MIRA also reaffirmed that the acquisition of SKNY Pharmaceuticals, which includes a first-in-class oral CB1/CB2 inverse agonist for obesity and smoking cessation (SKNY-1), is progressing on track. The Company has submitted the required regulatory filings for the merger to the U.S. Securities and Exchange Commission (SEC). The publication will be available upon release at: Cautionary Note Regarding Forward-Looking Statements This press release and the statements of MIRA's management related thereto contain "forward-looking statements," which are statements other than historical facts made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These statements may be identified by words such as "aims," "anticipates," "believes," "could," "estimates," "expects," "forecasts," "goal," "intends," "may," "plans," "possible," "potential," "seeks," "will," and variations of these words or similar expressions that are intended to identify forward-looking statements. Any statements in this press release that are not historical facts may be deemed forward-looking. Any forward-looking statements in this press release are based on MIRA's current expectations, estimates, and projections only as of the date of this release and are subject to a number of risks and uncertainties (many of which are beyond MIRA's control) that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements, including related to MIRA's potential merger with SKNY Pharmaceuticals, Inc. These and other risks concerning MIRA's programs and operations are described in additional detail in the Annual Report on Form 10-K for the year ended December 31, 2024, and other SEC filings, which are on file with the SEC at and MIRA's website at MIRA explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law. Contact Information Helga Moyainfo@ 432-9792 SOURCE: MIRA Pharmaceuticals
Miami Herald
15-05-2025
- Business
- Miami Herald
Telomir Pharmaceuticals Adds Telomir-Ag2 as a Novel Drug Candidate to Pipeline Following Breakthrough Efficacy Against MARSA and Drug-Resistant Infections, Targeting a $30B+ Antimicrobial Market Opportunity
Antimicrobial resistance is recognized as one of the top global public health threats, and Telomir-Ag2 strengthens Telomir's pipeline with a differentiated candidate designed to address this urgent and expanding crisis MIAMI, FL / ACCESS Newswire / May 15, 2025 / Telomir Pharmaceuticals, Inc. (NASDAQ:TELO), or Telomir, a leader in age-reversal science, today announced the identification of Telomir-Ag2 as a novel drug candidate for the treatment of bacterial infections, including those caused by drug-resistant pathogens. This follows Telomir's recent breakthrough in stabilizing Silver(II) in a biologically compatible form using its proprietary Telomir-1 platform. Telomir-Ag2 is a stabilized Silver(II) complex that demonstrated broad-spectrum antimicrobial activity in preclinical studies, including against methicillin- and aminoglycoside-resistant Staphylococcus aureus (MARSA), one of the most challenging pathogens in clinical settings. "In the lab, Silver(II) has always shown remarkable antimicrobial potential, but it was considered too unstable for real-world use," said Erez Aminov, CEO and Chairman of Telomir. "With Telomir-Ag2, we've taken that potential and made it practical. What we now have is a novel, biologically viable Silver(II) compound with broad-spectrum antibacterial activity - including against resistant strains. This creates the potential for a meaningful opportunity in areas where few effective solutions exist. We believe Telomir-Ag2 has the potential to not only address a critical unmet need in healthcare but also create meaningful long-term value for our shareholders." Study Results In Minimum Inhibitory Concentration (MIC) testing, Telomir-Ag2 demonstrated potent antibacterial activity against Escherichia coli, Pseudomonas aeruginosa, Enterococcus faecalis, Staphylococcus aureus, and MARSA. The compound also outperformed its Silver(I) counterpart, Telomir-Ag1, confirming the enhanced oxidative capacity and broader antimicrobial profile of Silver(II). "This is the first time we've seen a Silver(II) complex stabilized in a biologically friendly form while maintaining broad spectrum antimicrobial power," said Dr. Itzchak Angel, Chief Scientific Advisor at Telomir. "We're now looking at a completely new tool in the fight against antibiotic-resistant bacteria." The Urgency Behind MARSA and Burn Wound Infections MARSA is a drug-resistant variant of Staphylococcus aureus responsible for serious infections in hospitals and intensive care settings. In the United States, MRSA alone causes over 323,000 hospitalizations and more than 10,000 deaths annually, according to the CDC. Globally, resistant Staphylococcus aureus strains are estimated to contribute to over 100,000 deaths each year. Burn patients represent one of the highest-risk groups for these infections due to the loss of the skin's protective barrier. Infections in burn wounds are a major source of complications, delayed recovery, and mortality. While silver-based topical creams like silver sulfadiazine are commonly used, they present several limitations - including potential cytotoxicity to fibroblasts and keratinocytes and reduced efficacy over time due to rapid ion release. Telomir-Ag2 was designed to potentially overcome these challenges. By stabilizing Silver(II) through Telomir-1's proprietary chelation platform, the compound may enable more controlled silver release and sustained antimicrobial coverage. Telomir-Ag2 also contains no sulfa-based compounds, which are associated with allergic and cytotoxic reactions in some conventional silver formulations. Early findings suggest Silver(II) may support wound healing processes, making Telomir-Ag2 a compelling candidate for use in high-risk wounds, including burns and surgical sites. A New Class of Antimicrobials While most traditional antibiotics act on a single bacterial pathway, silver ions operate through multiple mechanisms simultaneously damaging membranes, binding to proteins and DNA, and generating reactive oxygen species (ROS). Silver(II), due to its high oxidative potential, is particularly effective, but has historically been too unstable for medical use. Telomir's potential ability to stabilize and deliver Silver(II) in a biologically compatible and effective form represents a significant step forward in antimicrobial innovation. "To our knowledge, Telomir-Ag2 is the first Silver(II) complex to move from theoretical promise to real therapeutic viability," said Dr. Alex Weisman, Scientific Chemical Advisor at Telomir. "This could pave the way for a new generation of broad-spectrum, resistance-resilient antimicrobials." Market Opportunity Telomir-Ag2 targets two rapidly growing segments within the healthcare market. The global silver wound dressings market is projected to grow from $1.03 billion in 2024 to $1.36 billion by 2030. Meanwhile, the antimicrobial coatings market is expected to increase from $11.65 billion in 2024 to $33.7 billion by 2031, reflecting a compound annual growth rate (CAGR) of 14.2% (Source: Verified Market Research, 2024). Strategic Value Potential The identification of Telomir-Ag2 adds a distinct and differentiated asset to Telomir's pipeline. The compound's broad-spectrum activity, including efficacy against drug-resistant strains such as MARSA, positions it as a potential therapeutic solution in high-need settings including hospitals, burn centers, and surgical care. Antimicrobial resistance has been formally recognized by the World Health Organization (WHO) as one of the top ten global public health threats facing humanity. According to WHO, drug-resistant infections could lead to 10 million deaths annually by 2050 without new solutions (WHO Fact Sheet, 2023). As Telomir-Ag2 progresses through development, Telomir believes it may provide strategic value through potential clinical utility, future partnerships, and the opportunity to address a high-priority medical challenge. Its advancement may contribute to long-term shareholder value and broaden Telomir's impact beyond age-related indications. Next Steps With preclinical efficacy confirmed, Telomir plans to move Telomir-Ag2 into formulation development, IND-enabling studies, and regulatory engagement. Telomir also plans to explore potential partnerships in the areas of wound care, infectious disease, and medical devices. "This is just the beginning," added Dr. Angel. "Silver(II) has always been the missing piece in advanced antimicrobial science. With Telomir-Ag2, we're closer than ever to making it part of modern medicine." Cautionary Note Regarding Forward-Looking Statements This press release, statements of Telomir's management or advisors related thereto, and the statements contained in the news story linked in this release contain "forward-looking statements," which are statements other than historical facts made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These risks and uncertainties include, but are not limited to, the potential use of the data from our studies, our ability to develop and commercialize Telomir-1 for specific indications, and the safety of Telomir-1. Any forward-looking statements in this press release are based on Telomir's current expectations, estimates and projections only as of the date of this release. These risks and uncertainties include, but are not limited to, the potential use of the data from our studies, our ability to develop and commercialize Telomir-1 for specific indications and safety of Telomir-1. These and other risks concerning Telomir's programs and operations are described in additional detail in its Annual Report on Form 10-K for the fiscal year ended December 31, 2024, which is on file with the SEC. Telomir explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law. Contact Information Helga Moya info@ 396-6723 SOURCE: Telomir Pharmaceuticals, Inc
