Latest news with #Tharimmune
Miami Herald
19-05-2025
- Health
- Miami Herald
Tharimmune Appoints Renowned Counter-Terrorism and Critical Infrastructure Expert James Gordon Liddy (CDR US Navy SEAL (Ret)) as Key Strategic Advisor Against Weaponized Fentanyl and Other High-Potency Opioids Following Positive FDA Feedback
BRIDGEWATER, NJ / ACCESS Newswire / May 19, 2025 / Tharimmune, Inc. (Nasdaq:THAR), a clinical-stage biopharmaceutical company focused on developing innovative therapeutics, today announced the appointment of James Gordon Liddy (CDR US Navy SEAL (Ret)) as a strategic advisor. Mr. Liddy, an internationally recognized expert on counterterrorism and critical infrastructure protection, will provide invaluable guidance as Tharimmune advances the development of TH104, its lead program for temporary prophylaxis against respiratory and/or central nervous system depression in military personnel and chemical incident responders exposed to high-potency opioids, including potential weaponized agents like fentanyl. Mr. Liddy brings a distinguished career and unparalleled expertise in national security and preparedness to Tharimmune. As the Senior Advisor to the Director for Strategy, Policy and Initiatives for the Office of the Assistant Secretary of Defense for Special Operations and Low Intensity Conflict, and previously the Chief of Plans and Policy for the United States Special Operations Command's Washington Office, he played a pivotal role in designing and coordinating policy, operational plans, and strategic initiatives for the Global War on Terrorism. His experience as a member of a highly classified national security program further underscores his deep understanding of the threats facing the nation. Notably, CDR Liddy's tenure as the Combating Terrorism and Special Operations Officer for the Chief of Naval Operations saw him as the principal architect for the Navy's Anti-Terrorism Force Protection Plan and the leader of the Navy's elite Antiterrorism Assessment Team (Red Cell). He also spearheaded the creation of DoD's Anti-terrorism and Force Protection Plan DoD Directive 20012.H, demonstrating his capability to develop and implement critical protective measures at the highest levels of government. Tharimmune recently announced positive feedback from the U.S. Food and Drug Administration (FDA) regarding the advancement of TH104 for the prophylaxis indication against ultrapotent opioid exposure. The FDA indicated that no additional clinical trials appear to be necessary prior to a 505(b)(2) New Drug Application (NDA) submission, allowing Tharimmune to leverage existing data and focus on this critical unmet need for military personnel and first responders. "We are honored to welcome James Gordon Liddy to our team as a strategic advisor," said Vincent LoPriore, Executive Chairman of Tharimmune. "His extensive background in counter-terrorism, critical infrastructure protection, and the development of national security strategies aligns perfectly with our mission to advance TH104 as a crucial medical countermeasure against the threat of weaponized opioids. Mr. Liddy's insights and guidance will be invaluable as we work to bring this potentially life-saving prophylaxis to those on the front lines." Mr. Liddy's deep expertise in threat assessment, preparedness, and response planning will provide Tharimmune with unique strategic perspectives as the company navigates the development and potential deployment of TH104 within national security frameworks. His understanding of the operational environments faced by military personnel and chemical incident responders, as well as the critical need for effective countermeasures, will be instrumental in shaping Tharimmune's approach. "I am impressed with Tharimmune's commitment to addressing the serious national security threat posed by high-potency opioids, including weaponized fentanyl," said James Gordon Liddy. "The potential of TH104 to provide a temporary prophylactic solution is significant. I look forward to contributing my experience to help guide Tharimmune's strategy and accelerate the availability of this important medical countermeasure to protect our servicemen and women and first responders." Mr. Liddy holds a Masters Degree from the John Hopkins University School of Advanced International Studies (SAIS) and has completed the Information Operations Curriculum at the National Defense University. He is also a Doctoral student in Complex Emergency and Disaster Management at Tulane University, with a Graduate CBRNE sub-specialty curriculum from the Uniformed Services Medical School, Bethesda MD. He is also the co-author of the New York Times bestseller, FIGHT BACK, Tackling Terrorism Liddy Style. About Tharimmune, Inc. Tharimmune is a clinical-stage biotechnology company developing a diverse portfolio of therapeutic candidates in immunology, inflammation and oncology. Its lead clinical asset, TH104, is being developed for a specific indication via a 505(b)2 pathway for respiratory and/or nervous system depression in military personnel and chemical incident responders who may encounter environments contaminated with high-potency opioids. The expanded pipeline includes other indications for TH104, such as chronic pruritus in primary biliary cholangitis and TH023, a new approach to treating autoimmune diseases along with an early-stage multispecific biologic platform targeting unique epitopes against multiple solid tumors through its proprietary EpiClick™ Technology. The Company has a license agreement with OmniAb, Inc. to access their antibody discovery technology for targeting specified disease markers. Tharimmune continues to position itself as a leader in patient-centered innovation while working to deliver long-term value for shareholders. For more information, visit: Forward Looking Statements Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, contained in this press release, including statements regarding the timing and design of Tharimmune's future Phase 2 trial, Tharimmune's strategy, future operations, future financial position, projected costs, prospects, plans and objectives of management, are forward-looking statements. The words "anticipate," "believe," "continue," "could," "depends," "estimate," "expect," "intend," "may," "ongoing," "plan," "potential," "predict," "project," "target," "should," "will," "would," and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. The Company may not actually achieve the plans, intentions, or expectations disclosed in these forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements. Factors that may cause such differences, include, but are not limited to, those discussed under Risk Factors set forth in our Annual Report on Form 10-K for the year ended December 31, 2024 and other periodic reports filed by the Company from time to time with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company's views as of the date of this release. Subsequent events and developments may cause the Company's views to change; however, the Company does not undertake and specifically disclaims any obligation to update or revise any forward-looking statements to reflect new information, future events or circumstances or to reflect the occurrences of unanticipated events, except as may be required by applicable law. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date of this release. Contacts Tharimmune, Alliance Advisors IRTirth T. Pateltpatel@ SOURCE: Tharimmune Inc.
Associated Press
19-05-2025
- Health
- Associated Press
Tharimmune Appoints Renowned Counter-Terrorism and Critical Infrastructure Expert James Gordon Liddy (CDR US Navy SEAL (Ret)) as Key Strategic Advisor Against Weaponized Fentanyl and Other High-Potency Opioids Following Positive FDA Feedback
BRIDGEWATER, NJ / ACCESS Newswire / May 19, 2025 / Tharimmune, Inc. (Nasdaq:THAR), a clinical-stage biopharmaceutical company focused on developing innovative therapeutics, today announced the appointment of James Gordon Liddy (CDR US Navy SEAL (Ret)) as a strategic advisor. Mr. Liddy, an internationally recognized expert on counterterrorism and critical infrastructure protection, will provide invaluable guidance as Tharimmune advances the development of TH104, its lead program for temporary prophylaxis against respiratory and/or central nervous system depression in military personnel and chemical incident responders exposed to high-potency opioids, including potential weaponized agents like fentanyl. Mr. Liddy brings a distinguished career and unparalleled expertise in national security and preparedness to Tharimmune. As the Senior Advisor to the Director for Strategy, Policy and Initiatives for the Office of the Assistant Secretary of Defense for Special Operations and Low Intensity Conflict, and previously the Chief of Plans and Policy for the United States Special Operations Command's Washington Office, he played a pivotal role in designing and coordinating policy, operational plans, and strategic initiatives for the Global War on Terrorism. His experience as a member of a highly classified national security program further underscores his deep understanding of the threats facing the nation. Notably, CDR Liddy's tenure as the Combating Terrorism and Special Operations Officer for the Chief of Naval Operations saw him as the principal architect for the Navy's Anti-Terrorism Force Protection Plan and the leader of the Navy's elite Antiterrorism Assessment Team (Red Cell). He also spearheaded the creation of DoD's Anti-terrorism and Force Protection Plan DoD Directive 20012.H, demonstrating his capability to develop and implement critical protective measures at the highest levels of government. Tharimmune recently announced positive feedback from the U.S. Food and Drug Administration (FDA) regarding the advancement of TH104 for the prophylaxis indication against ultrapotent opioid exposure. The FDA indicated that no additional clinical trials appear to be necessary prior to a 505(b)(2) New Drug Application (NDA) submission, allowing Tharimmune to leverage existing data and focus on this critical unmet need for military personnel and first responders. 'We are honored to welcome James Gordon Liddy to our team as a strategic advisor,' said Vincent LoPriore, Executive Chairman of Tharimmune. 'His extensive background in counter-terrorism, critical infrastructure protection, and the development of national security strategies aligns perfectly with our mission to advance TH104 as a crucial medical countermeasure against the threat of weaponized opioids. Mr. Liddy's insights and guidance will be invaluable as we work to bring this potentially life-saving prophylaxis to those on the front lines.' Mr. Liddy's deep expertise in threat assessment, preparedness, and response planning will provide Tharimmune with unique strategic perspectives as the company navigates the development and potential deployment of TH104 within national security frameworks. His understanding of the operational environments faced by military personnel and chemical incident responders, as well as the critical need for effective countermeasures, will be instrumental in shaping Tharimmune's approach. 'I am impressed with Tharimmune's commitment to addressing the serious national security threat posed by high-potency opioids, including weaponized fentanyl,' said James Gordon Liddy. 'The potential of TH104 to provide a temporary prophylactic solution is significant. I look forward to contributing my experience to help guide Tharimmune's strategy and accelerate the availability of this important medical countermeasure to protect our servicemen and women and first responders.' Mr. Liddy holds a Masters Degree from the John Hopkins University School of Advanced International Studies (SAIS) and has completed the Information Operations Curriculum at the National Defense University. He is also a Doctoral student in Complex Emergency and Disaster Management at Tulane University, with a Graduate CBRNE sub-specialty curriculum from the Uniformed Services Medical School, Bethesda MD. He is also the co-author of the New York Times bestseller, FIGHT BACK, Tackling Terrorism Liddy Style. About Tharimmune, Inc. Tharimmune is a clinical-stage biotechnology company developing a diverse portfolio of therapeutic candidates in immunology, inflammation and oncology. Its lead clinical asset, TH104, is being developed for a specific indication via a 505(b)2 pathway for respiratory and/or nervous system depression in military personnel and chemical incident responders who may encounter environments contaminated with high-potency opioids. The expanded pipeline includes other indications for TH104, such as chronic pruritus in primary biliary cholangitis and TH023, a new approach to treating autoimmune diseases along with an early-stage multispecific biologic platform targeting unique epitopes against multiple solid tumors through its proprietary EpiClick™ Technology. The Company has a license agreement with OmniAb, Inc. to access their antibody discovery technology for targeting specified disease markers. Tharimmune continues to position itself as a leader in patient-centered innovation while working to deliver long-term value for shareholders. For more information, visit: Forward Looking Statements Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, contained in this press release, including statements regarding the timing and design of Tharimmune's future Phase 2 trial, Tharimmune's strategy, future operations, future financial position, projected costs, prospects, plans and objectives of management, are forward-looking statements. The words 'anticipate,' 'believe,' 'continue,' 'could,' 'depends,' 'estimate,' 'expect,' 'intend,' 'may,' 'ongoing,' 'plan,' 'potential,' 'predict,' 'project,' 'target,' 'should,' 'will,' 'would,' and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. The Company may not actually achieve the plans, intentions, or expectations disclosed in these forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements. Factors that may cause such differences, include, but are not limited to, those discussed under Risk Factors set forth in our Annual Report on Form 10-K for the year ended December 31, 2024 and other periodic reports filed by the Company from time to time with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company's views as of the date of this release. Subsequent events and developments may cause the Company's views to change; however, the Company does not undertake and specifically disclaims any obligation to update or revise any forward-looking statements to reflect new information, future events or circumstances or to reflect the occurrences of unanticipated events, except as may be required by applicable law. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date of this release. Contacts Tharimmune, Inc. [email protected] Alliance Advisors IR Tirth T. Patel [email protected] 212-201-6614 SOURCE: Tharimmune Inc. press release
Yahoo
19-05-2025
- Health
- Yahoo
Tharimmune Appoints Renowned Counter-Terrorism and Critical Infrastructure Expert James Gordon Liddy (CDR US Navy SEAL (Ret)) as Key Strategic Advisor Against Weaponized Fentanyl and Other High-Potency Opioids Following Positive FDA Feedback
BRIDGEWATER, NJ / / May 19, 2025 / Tharimmune, Inc. (Nasdaq:THAR), a clinical-stage biopharmaceutical company focused on developing innovative therapeutics, today announced the appointment of James Gordon Liddy (CDR US Navy SEAL (Ret)) as a strategic advisor. Mr. Liddy, an internationally recognized expert on counterterrorism and critical infrastructure protection, will provide invaluable guidance as Tharimmune advances the development of TH104, its lead program for temporary prophylaxis against respiratory and/or central nervous system depression in military personnel and chemical incident responders exposed to high-potency opioids, including potential weaponized agents like fentanyl. Mr. Liddy brings a distinguished career and unparalleled expertise in national security and preparedness to Tharimmune. As the Senior Advisor to the Director for Strategy, Policy and Initiatives for the Office of the Assistant Secretary of Defense for Special Operations and Low Intensity Conflict, and previously the Chief of Plans and Policy for the United States Special Operations Command's Washington Office, he played a pivotal role in designing and coordinating policy, operational plans, and strategic initiatives for the Global War on Terrorism. His experience as a member of a highly classified national security program further underscores his deep understanding of the threats facing the nation. Notably, CDR Liddy's tenure as the Combating Terrorism and Special Operations Officer for the Chief of Naval Operations saw him as the principal architect for the Navy's Anti-Terrorism Force Protection Plan and the leader of the Navy's elite Antiterrorism Assessment Team (Red Cell). He also spearheaded the creation of DoD's Anti-terrorism and Force Protection Plan DoD Directive 20012.H, demonstrating his capability to develop and implement critical protective measures at the highest levels of government. Tharimmune recently announced positive feedback from the U.S. Food and Drug Administration (FDA) regarding the advancement of TH104 for the prophylaxis indication against ultrapotent opioid exposure. The FDA indicated that no additional clinical trials appear to be necessary prior to a 505(b)(2) New Drug Application (NDA) submission, allowing Tharimmune to leverage existing data and focus on this critical unmet need for military personnel and first responders. "We are honored to welcome James Gordon Liddy to our team as a strategic advisor," said Vincent LoPriore, Executive Chairman of Tharimmune. "His extensive background in counter-terrorism, critical infrastructure protection, and the development of national security strategies aligns perfectly with our mission to advance TH104 as a crucial medical countermeasure against the threat of weaponized opioids. Mr. Liddy's insights and guidance will be invaluable as we work to bring this potentially life-saving prophylaxis to those on the front lines." Mr. Liddy's deep expertise in threat assessment, preparedness, and response planning will provide Tharimmune with unique strategic perspectives as the company navigates the development and potential deployment of TH104 within national security frameworks. His understanding of the operational environments faced by military personnel and chemical incident responders, as well as the critical need for effective countermeasures, will be instrumental in shaping Tharimmune's approach. "I am impressed with Tharimmune's commitment to addressing the serious national security threat posed by high-potency opioids, including weaponized fentanyl," said James Gordon Liddy. "The potential of TH104 to provide a temporary prophylactic solution is significant. I look forward to contributing my experience to help guide Tharimmune's strategy and accelerate the availability of this important medical countermeasure to protect our servicemen and women and first responders." Mr. Liddy holds a Masters Degree from the John Hopkins University School of Advanced International Studies (SAIS) and has completed the Information Operations Curriculum at the National Defense University. He is also a Doctoral student in Complex Emergency and Disaster Management at Tulane University, with a Graduate CBRNE sub-specialty curriculum from the Uniformed Services Medical School, Bethesda MD. He is also the co-author of the New York Times bestseller, FIGHT BACK, Tackling Terrorism Liddy Style. About Tharimmune, Inc. Tharimmune is a clinical-stage biotechnology company developing a diverse portfolio of therapeutic candidates in immunology, inflammation and oncology. Its lead clinical asset, TH104, is being developed for a specific indication via a 505(b)2 pathway for respiratory and/or nervous system depression in military personnel and chemical incident responders who may encounter environments contaminated with high-potency opioids. The expanded pipeline includes other indications for TH104, such as chronic pruritus in primary biliary cholangitis and TH023, a new approach to treating autoimmune diseases along with an early-stage multispecific biologic platform targeting unique epitopes against multiple solid tumors through its proprietary EpiClick™ Technology. The Company has a license agreement with OmniAb, Inc. to access their antibody discovery technology for targeting specified disease markers. Tharimmune continues to position itself as a leader in patient-centered innovation while working to deliver long-term value for shareholders. For more information, visit: Forward Looking Statements Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, contained in this press release, including statements regarding the timing and design of Tharimmune's future Phase 2 trial, Tharimmune's strategy, future operations, future financial position, projected costs, prospects, plans and objectives of management, are forward-looking statements. The words "anticipate," "believe," "continue," "could," "depends," "estimate," "expect," "intend," "may," "ongoing," "plan," "potential," "predict," "project," "target," "should," "will," "would," and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. The Company may not actually achieve the plans, intentions, or expectations disclosed in these forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements. Factors that may cause such differences, include, but are not limited to, those discussed under Risk Factors set forth in our Annual Report on Form 10-K for the year ended December 31, 2024 and other periodic reports filed by the Company from time to time with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company's views as of the date of this release. Subsequent events and developments may cause the Company's views to change; however, the Company does not undertake and specifically disclaims any obligation to update or revise any forward-looking statements to reflect new information, future events or circumstances or to reflect the occurrences of unanticipated events, except as may be required by applicable law. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date of this release. Contacts Tharimmune, Alliance Advisors IRTirth T. Pateltpatel@ SOURCE: Tharimmune Inc. View the original press release on ACCESS Newswire Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Miami Herald
06-05-2025
- Health
- Miami Herald
Tharimmune Presents Positive Clinical Data Highlighting TH104 Metabolic Profile and Advances Program for Prophylaxis Against Ultrapotent Opioid Exposure Following FDA Feedback
Press Releases Tharimmune Presents Positive Clinical Data Highlighting TH104 Metabolic Profile and Advances Program for Prophylaxis Against Ultrapotent Opioid Exposure Following FDA Feedback Tharimmune, Inc., (Nasdaq:THAR) ("Tharimmune" or the "Company") a clinical-stage biopharmaceutical company focused on developing innovative therapeutics in inflammation & immunology released pharmacokinetic and metabolism data from its Phase 1 study of TH104, a buccal film formulation of nalmefene, in healthy subjects. Tharimmune recently highlighted the advancement of TH104 for the proposed indication of temporary prophylaxis against respiratory and/or central nervous system depression in military personnel and chemical incident responders exposed to high-potency opioids, following recent positive feedback from the U.S. Food and Drug Administration (FDA). The Phase 1 study presented this week at Digestive Disease Week taking place in San Diego, California evaluated the pharmacokinetics and metabolism of a single dose of TH104 (16 mg buccal film) compared to an intravenous (IV) dose of nalmefene injection (1 mg) in healthy volunteers. The study successfully demonstrated that buccal administration of TH104 achieves systemic exposure to nalmefene while offering a distinct metabolic profile compared to IV administration. Phases of drug metabolism (such as phase 1 and phase 2) denote the "breaking down" and "tagging" of drugs, generally into molecules known as metabolites, by the liver to prepare them for removal. The key difference with drugs taken by mouth is the "first-pass effect," where the drug goes through the liver's processing immediately after being absorbed from the gut, before the drug circulates throughout the body. Drugs injected into the bloodstream bypass this initial liver processing generally leading to more drug circulating in the body before being metabolized. Key findings from the pharmacokinetic study presented at the Digestive Disease Week 2025 included: Buccal administration of TH104 resulted in slower absorption compared to IV administration The ratio of the area under the curve (AUC) of nalmefene glucuronide, a metabolite, compared to nalmefene was significantly higher for TH104 versus IV administration Pharmacokinetics of nalmefene sulfate and nornalmefene, 2 other metabolites, were significantly delayed with TH104 compared to IV administration Both formulations showed early phase 2 metabolism (glucuronidation), but importantly, TH104 demonstrated delayed phase 1 metabolism, which is mainly catalyzed by enzymes such as cytochrome P450 oxidases in the liver By attenuating the burden on hepatic metabolic pathways, TH104 may represent a novel therapeutic candidate for individuals with impaired liver function. The altered pharmacokinetic profile, particularly the delayed onset of phase 1 metabolism observed with buccal administration may confer a potential advantage in populations with impaired hepatic function, and may be important in patients with primary biliary cholangitis (PBC). PBC is a rare cholestatic liver disease frequently associated with intractable pruritus. Tharimmune is also advancing TH104 as a therapeutic agent for the management of moderate-to-severe chronic pruritus in PBC patients. "The compelling pharmacokinetic data from our Phase 1 study not only supports the continued development of TH104 for symptomatic pruritus in liver disease by highlighting a potentially liver-friendly metabolic profile but importantly provides a crucial foundation for our accelerated development pathway in the opioid prophylaxis setting," said Randy Milby, CEO of Tharimmune. "The positive feedback from the FDA, namely a 505(b)(2) submission without the need for additional clinical trials for the prophylaxis indication is a transformative milestone for Tharimmune and positions TH104 as our lead program to address a critical unmet need for military personnel and first responders facing the threat of high-potency opioid exposure." The Phase 1 results in healthy subjects also demonstrated comparable safety and tolerability between TH104 and IV nalmefene, with only mild adverse events reported. Building on the favorable pharmacokinetic and safety profile, Tharimmune is advancing TH104 as a critical medical countermeasure product. Following positive feedback from the FDA, Tharimmune is pursuing a 505(b)(2) regulatory pathway for TH104 for the temporary prophylaxis of respiratory and/or CNS depression in military personnel and chemical incident responders who may encounter environments contaminated with high-potency opioids, including weaponized fentanyl and its analogues. The FDA has indicated that no additional clinical trials appear to be necessary prior to the submission of a New Drug Application (NDA) for this indication, allowing Tharimmune to leverage existing safety and efficacy data for nalmefene along with the pharmacokinetic data generated with the TH104 buccal film. This expedited pathway underscores the urgent need for such a prophylactic solution, particularly for chemical incident responders operating in high-risk environments where exposure to highly potent opioids is a potential threat to national security. The buccal film formulation offers a distinct advantage for rapid and convenient administration, even when personnel are wearing protective gear. About Tharimmune, Inc. Tharimmune is a clinical-stage biotechnology company developing a diverse portfolio of therapeutic candidates in immunology, inflammation and oncology. Its lead clinical asset, TH104, is being developed for a specific indication via a 505(b)2 pathway for respiratory and/or nervous system depression in military personnel and chemical incident responders who may encounter environments contaminated with high-potency opioids. The expanded pipeline includes other indications for TH104, such as chronic pruritus in primary biliary cholangitis and TH023, a new approach to treating autoimmune diseases along with an early-stage multispecific biologic platform targeting unique epitopes against multiple solid tumors through its proprietary EpiClick™ Technology. The Company has a license agreement with OmniAb, Inc. to access their antibody discovery technology for targeting specified disease markers. Tharimmune continues to position itself as a leader in patient-centered innovation while working to deliver long-term value for shareholders. For more information, visit: Forward Looking Statements Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, contained in this press release, including statements regarding the timing and design of Tharimmune's future Phase 2 trial, Tharimmune's strategy, future operations, future financial position, projected costs, prospects, plans and objectives of management, are forward-looking statements. The words "anticipate," "believe," "continue," "could," "depends," "estimate," "expect," "intend," "may," "ongoing," "plan," "potential," "predict," "project," "target," "should," "will," "would," and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. The Company may not actually achieve the plans, intentions, or expectations disclosed in these forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements. Factors that may cause such differences, include, but are not limited to, those discussed under Risk Factors set forth in our Annual Report on Form 10-K for the year ended December 31, 2024 and other periodic reports filed by the Company from time to time with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company's views as of the date of this release. Subsequent events and developments may cause the Company's views to change; however, the Company does not undertake and specifically disclaims any obligation to update or revise any forward-looking statements to reflect new information, future events or circumstances or to reflect the occurrences of unanticipated events, except as may be required by applicable law. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date of this release. Contacts: Tharimmune, Inc. ir@ Alliance Advisors IR Tirth T. Patel tpatel@ 212-201-6614 SOURCE: Tharimmune Inc. This story was originally published May 6, 2025 at 8:06 AM.
Associated Press
28-04-2025
- Health
- Associated Press
Tharimmune Advances TH104 for Prophylaxis Against Weaponized Fentanyl and Other High-Potency Opioids Following Positive FDA Feedback
BRIDGEWATER, NEW JERSEY / ACCESS Newswire / April 28, 2025 / Tharimmune, Inc., (Nasdaq:THAR) ('Tharimmune' or the 'Company') a clinical-stage biopharmaceutical company focused on developing innovative therapeutics in inflammation & immunology, recently announced positive feedback from the U.S. Food and Drug Administration (FDA) regarding TH104. The agency confirmed that no additional clinical trials appear to be necessary prior to a 505(b)(2) New Drug Application (NDA) submission. TH104 is a buccal film formulation, of nalmefene specifically designed for rapid absorption with a potential for bypassing liver metabolism. This allows TH104 to be suitable for the temporary prophylaxis of respiratory and/or nervous system depression in military personnel and chemical incident responders who may be exposed to high-potency opioids, including weaponized fentanyl and its analogues. This significant regulatory milestone underscores the urgent need for specialized medical countermeasures highlighted in a recent market assessment concerning the United States Strategic National Stockpile (SNS). This assessment specifically addressed the growing threat posed by chemicals of concern, with a primary focus on the increasing risk of high-potency synthetic opioids like fentanyl and its numerous derivatives being weaponized and deployed as aerosolized agents. The U.S. government has increasingly recognized fentanyl and its related compounds as significant national security threats due to their extreme potency and the potential for mass casualty incidents if weaponized. These substances, significantly more potent than traditional opioids, pose a grave risk through inhalation, dermal contact, or ingestion. The 2002 Moscow theater hostage crisis, where aerosolized synthetic opioids were reportedly used, tragically demonstrated the devastating potential of such agents in a mass casualty scenario. This event, alongside intelligence indicating potential adversary interest in opioid-based chemical weapons, has heightened the priority for developing effective prophylactic measures for frontline personnel/first responders. SNS market assessment identified a critical need for countermeasures that can be administered prior to or immediately upon potential exposure to these agents, preventing or mitigating the rapid onset of respiratory and nervous system depression. Key findings from this analysis further emphasize the importance of Tharimmune's work: 'The positive feedback from the FDA on the NDA pathway for TH104 is a crucial step forward in addressing a critical national security concern - the potential weaponization of fentanyl and its derivatives,' said Randy Milby, CEO of Tharimmune. 'The market assessment clearly articulates the need for more options as effective prophylactic solutions for those on the front lines. TH104's novel formulation and pharmacokinetic profile could provide a significant advantage in protecting military personnel and chemical incident responders from the immediate and life-threatening effects of opioid exposure in contaminated environments.' The development of TH104 aligns directly with the U.S. government's increasing focus on preparedness against chemical threats, particularly those involving highly potent opioids. The positive FDA feedback provides a clear impetus for Tharimmune to continue its development program and work towards making this potentially life-saving prophylactic available to those who need it most. About Tharimmune, Inc. Tharimmune is a clinical-stage biotechnology company developing a diverse portfolio of therapeutic candidates in immunology, inflammation and oncology. Its lead clinical asset, TH104, is being developed for a specific indication via a 505(b)2 pathway for respiratory and/or nervous system depression in military personnel and chemical incident responders who may encounter environments contaminated with high-potency opioids. The expanded pipeline includes other indications for TH104, such as chronic pruritus in primary biliary cholangitis and TH023, a new approach to treating autoimmune diseases along with an early-stage multispecific biologic platform targeting unique epitopes against multiple solid tumors through its proprietary EpiClick™Technology. The Company has a license agreement with OmniAb, Inc. to access their antibody discovery technology for targeting specified disease markers. For more information, please visit: Forward Looking Statements Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, contained in this press release, including statements regarding the timing and design of Tharimmune's future Phase 2 trial, Tharimmune's strategy, future operations, future financial position, projected costs, prospects, plans and objectives of management, are forward-looking statements. The words 'anticipate,' 'believe,' 'continue,' 'could,' 'depends,' 'estimate,' 'expect,' 'intend,' 'may,' 'ongoing,' 'plan,' 'potential,' 'predict,' 'project,' 'target,' 'should,' 'will,' 'would,' and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. The Company may not actually achieve the plans, intentions, or expectations disclosed in these forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements. Factors that may cause such differences, include, but are not limited to, those discussed under Risk Factors set forth in our Annual Report on Form 10-K for the year ended December 31, 2024 and other periodic reports filed by the Company from time to time with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company's views as of the date of this release. Subsequent events and developments may cause the Company's views to change; however, the Company does not undertake and specifically disclaims any obligation to update or revise any forward-looking statements to reflect new information, future events or circumstances or to reflect the occurrences of unanticipated events, except as may be required by applicable law. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date of this release. Contacts Tharimmune, Inc. [email protected] Alliance Advisors IR Tirth T. Patel [email protected] 212-201-6614 SOURCE: Tharimmune Inc. press release
