Tharimmune reports pharmacokinetic simulation results for TH104

Tharimmune (THAR) announced results from a recent pharmacokinetic simulation analysis of its lead clinical asset, TH104, a buccal film formulation of nalmefene. The results reinforce the potential of TH104 as a prophylactic countermeasure for military personnel and chemical incident responders who may be exposed to high-potency opioids, including weaponized fentanyl and its analogues. Fentanyl and related compounds pose national security threats due to their high potency and the potential for a devastating mass casualty incident if weaponized. There is a critical need for countermeasures that can be administered proactively, prior to potential exposure, to prevent or mitigate the rapid onset of respiratory and nervous system depression from these potent agents. The analysis used pharmacokinetic simulations of TH104 as prophylaxis for respiratory depression in exposure to synthetic opioids based on data from the literature. The concentrations of TH104 necessary to block fentanyl respiratory depression were derived and simulations involved data from our Phase 1 study to generate concentration time curves above these concentrations. Using a conservative nalmefene concentration target – a threshold effect, was found to be achieved in approximately 30 minutes post dose and shown to maintain above this protection for about 24 hours. This is a potential key superiority of TH104 compared to currently available options. While naloxone injection can be used as a life-saving rescue medication, its effect is relatively short-lived, often lasting approximately 30-90 minutes. The prolonged prophylactic window of TH104 could be crucial in high-risk environments where exposure is a constant threat and immediate access to medical personnel may be limited. The ability of TH104 to potentially provide sustained protection is a significant advancement in prophylactic care against these potent agents. The buccal film delivery of TH104 is designed as a non-injectable, rapid absorption and convenient-to-use administration, which may be advantageous for first responders who may be wearing full protective gear. The recent positive feedback earlier this year from the U.S. Food and Drug Administration confirming that no additional clinical trials appear necessary prior to a 505(b)(2) New Drug Application submission provides a path forward. Tharimmune is dedicated to advancing TH-104 to provide a potentially effective and patient-friendly treatment as an option for those in need, beginning with its critical role in national security.