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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
Miami Herald
08-05-2025
- Business
- Miami Herald
MIRA Pharmaceuticals Announces Board Approval of SKNY Acquisition Reflecting $60+ Million in Combined Enterprise Value Based on Independent Review
With valuations confirmed by the board, MIRA advances strategic acquisition targeting obesity and nicotine dependence, which includes a $5 million contribution in cash or assets from SKNY to be transferred at closing. MIAMI, FLORIDA / ACCESS Newswire / May 8, 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 its Board of Directors has approved the planned acquisition of SKNY Pharmaceuticals, Inc. (the "Merger"), following the completion of independent valuation reports on both companies. The Merger remains subject to MIRA and SKNY's shareholder approval. A third-party analysis conducted by Moore Financial Consulting ("Moore") assigned SKNY Pharmaceuticals an enterprise value of approximately $30.5 million, based on a risk-adjusted net present value (rNPV) of its lead compound, SKNY-1. MIRA was separately valued by Moore at $30 million, further validating the strength and synergy of the combined pipeline. As outlined in the previously announced binding letter of intent for the merger between MIRA and SKNY-1, upon the closing, SKNY must hold at least $5 million in cash or other assets, to be transferred at closing, and the Company is preparing a filing with the U.S. Securities and Exchange Commission to seek shareholder approval. As MIRA advances this merger, the combined enterprise value (based on Moore's valuations) of over $60 million represents a strong platform for expansion into high-value therapeutic markets. According to MIRA CEO Erez Aminov, the acquisition "brings together two pipelines, two market opportunities, and one unified strategy, developing targeted, first-in-class therapies for urgent public health needs." Targeting Major Markets with a Differentiated Mechanism SKNY-1 is being developed as a next-generation oral therapeutic designed to modulate CB1 and CB2 cannabinoid receptors, as well as monoamine oxidase B (MAO-B)-an enzyme involved in dopamine metabolism and addiction regulation. This multi-target mechanism is being evaluated for its potential to address both metabolic dysfunction and nicotine dependence, providing a differentiated therapeutic alternative in two of the most urgent health markets globally. The global weight loss drug market is projected to surpass $150 billion by 2030, driven by growing demand for safer and more tolerable alternatives to GLP-1-based injectables (Source: Reuters).The U.S. smoking cessation market is projected to grow from $28.11 billion in 2024 to $50.90 billion by 2030, at a CAGR of 10.4% (Source: Grand View Research). These are large, underserved markets with limited innovation, and MIRA's leadership believes the addition of SKNY-1 to the Company's pipeline enhances its ability to compete in both. Dr. Itzchak Angel, Chief Scientific Advisor at MIRA, noted that SKNY-1's pharmacological profile, particularly its combined activity on both MAO-B and cannabinoid receptors, makes it a unique and promising candidate for craving, addiction and metabolic conditions with a sound neurochemical basis. "From a scientific perspective, this is a rationally designed molecule that addresses the biological complexity of both obesity and addiction," said Dr. Angel. "The early data are promising, and I'm looking forward to advancing its development." Strategic Value for the Future With both companies independently valued by Moore at approximately $30 million, MIRA believes this transaction creates a platform with scale, differentiated science, and a pipeline built to target urgent unmet needs. The Company views this merger as a foundation for long-term growth and innovation. Additional information about MIRA Pharmaceuticals is available 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
06-05-2025
- Business
- Miami Herald
MIRA Pharmaceuticals Reports No Brain Toxicity in FDA-Required Study of Ketamir-2, Confirming Absence of Ketamine-Linked Neurotoxicity
Press Releases MIRA Pharmaceuticals Reports No Brain Toxicity in FDA-Required Study of Ketamir-2, Confirming Absence of Ketamine-Linked Neurotoxicity Preclinical data supports the advancement of oral Ketamir-2 as a safe, next-generation alternative to ketamine, with ongoing momentum in Phase I clinical trial enrollment MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA) ("MIRA" or the "Company"), a clinical-stage pharmaceutical company focused on developing breakthrough treatments for neurological and neuropsychiatric conditions, today announced positive results from a neurotoxicity study of Ketamir-2, its novel oral NMDA receptor antagonist. The study was required by the U.S. Food and Drug Administration (FDA) prior to initiating human dosing in the United States. The preclinical study showed no evidence of brain toxicity, including the absence of Olney lesions-vacuolar brain changes historically associated with older NMDA-targeting drugs such as ketamine and MK-801. These results further confirm the favorable safety profile of Ketamir-2 and support its safe continued clinical development. "These results represent a key milestone in the development of Ketamir-2," said Erez Aminov, Chairman and CEO of MIRA. "The absence of NMDA-linked neurotoxicity, along with continued clinical progress, reinforces our confidence in Ketamir-2's potential as a safe next-generation, oral candidate for CNS disorders." Study Overview and Key Findings The neurotoxicity study was conducted in sexually mature Sprague-Dawley rats. High oral doses of Ketamir-2 were administered, while a positive control group received MK-801, a known neurotoxic NMDA receptor antagonist. Brain tissues were examined through detailed histopathological analysis at two time points. Key outcomes: No adverse clinical signs or mortality in any Ketamir-2-treated animals. No microscopic or macroscopic brain lesions detected at any dose. MK-801-treated animals showed clear evidence of brain toxicity, including vacuolation and neuronal necrosis. "These findings eliminate one of the main safety concerns that has historically limited NMDA-targeting therapies," said Dr. Itzchak Angel, Chief Scientific Advisor at MIRA. "Ketamir-2's clean neurotoxicity profile strengthens its position as a differentiated and promising therapeutic candidate." Why Ketamir-2 Stands Apart Ketamir-2 is a New Molecular Entity (NME) designed to modulate the NMDA receptor with a reduced affinity for the PCP binding site, which is strongly associated with neurotoxicity and psychotropic effects in legacy compounds like ketamine. In prior preclinical studies, Ketamir-2 has: Demonstrated full reversal of pain thresholds in validated neuropathic pain models. Outperformed FDA-approved treatments such as gabapentin and pregabalin. Shown no sedation or hyperactivity. Demonstrated strong oral bioavailability and brain penetration, as it is not a substrate for P-glycoprotein (P-gp). Ketamir-2 was designed for oral administration, offering a non-invasive alternative to intravenous therapies. In addition, the U.S. Drug Enforcement Administration (DEA) has determined that Ketamir-2 is not classified as a controlled substance, which may streamline development, reduce regulatory burdens, and improve future access if approved. Clinical Progress and What's Next MIRA has already initiated its Phase I clinical trial, with subject recruitment actively underway and progressing smoothly. The Company is preparing to launch a Phase IIa proof-of-concept trial in diabetic patients with neuropathic pain, with the goal of validating clinical efficacy and supporting future regulatory milestones. The newly completed neurotoxicity study results will be submitted to the FDA as part of MIRA's ongoing regulatory and clinical development strategy. Additional information about MIRA Pharmaceuticals is available 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 Moya info@ (786) 432-9792 SOURCE: MIRA Pharmaceuticals This story was originally published May 6, 2025 at 8:06 AM.
