Tharimmune sees TH104 as national security solution against fentanyl, opioids

The company said, “Tharimmune’s (THAR) lead asset, TH104, a buccal film formulation of nalmefene, has rapidly advanced with a regulatory pathway to address the escalating national security threat posed by weaponized fentanyl and other high-potency opioids like fentanyl. The U.S. government has increasingly recognized fentanyl and its related compounds as significant national security threats due to their extreme potency and potential for mass casualty incidents if weaponized. Incidents such as the 2002 Moscow theater hostage crisis, where aerosolized synthetic opioids were reportedly used, tragically demonstrated the devastating potential of such agents. In this critical context, Tharimmune explicitly positions TH104 as a direct response to this growing threat, aligning with the urgent need for specialized prophylactic medical countermeasures highlighted in recent U.S. Strategic National Stockpile market assessments. While existing solutions like naloxone auto-injectors are vital for emergency reversal, they often have a relatively short half-life. This can necessitate repeated dosing, particularly with longer-acting or highly potent synthetic opioids like fentanyl, which can have a significantly longer half-life. TH104, which utilizes nalmefene, offers a crucial advantage with a significantly longer plasma half-life of approximately 8 to 11 hours. This extended duration of action means TH104 provides sustained protection, potentially reducing the need for continuous monitoring and potential multiple redosing in a high-risk environment. Furthermore, TH104’s buccal film formulation allows for rapid and convenient administration, a critical benefit for military personnel and chemical incident responders who may be wearing full protective gear, where intramuscular injections can be impractical or delayed. In a pivotal development, Tharimmune previously announced positive feedback from the FDA regarding the New Drug Application path for TH104. Crucially, the FDA confirmed that no additional clinical trials appear to be necessary prior to a 505(b)(2) NDA submission for TH104’s proposed indication: “Temporary Prophylaxis of Respiratory and/or Nervous System Depression in Military Personnel and Chemical Incident Responders Entering an Area Contaminated with High-Potency Opioids.” This expedited pathway allows Tharimmune to leverage existing extensive safety and efficacy data for nalmefene, combined with the Company’s human pharmacokinetic data, enabling an “in silico” submission model, significantly accelerating its potential availability. Positive Phase 1 clinical data for TH104, presented at prominent conferences including Digestive Disease Week and the European Association for the Study of the Liver International Liver Congress in May 2025, highlights its distinct pharmacokinetic and metabolic profile. The data demonstrated that buccal administration achieves systemic exposure to nalmefene with reliable and predictable absorption and delayed phase 1 metabolism, potentially offering advantages for individuals with impaired liver function as potential added benefit. This scientific validation underpins TH104’s suitability as a critical medical countermeasure. Tharimmune has strategically fortified its leadership to advance TH104’s national security mission. James Gordon Liddy. a renowned counter-terrorism and critical infrastructure expert, has been appointed to the Board of Directors and serves as a Key Strategic Advisor. His unparalleled expertise in national security and preparedness, including his role in designing and coordinating policy for the Global War on Terrorism and architecting the Navy’s Anti-Terrorism Force Protection Plan, provides invaluable guidance for the development and potential deployment of TH104 within national security frameworks.”