- The FDA has given Tharimmune (THAR, Financial) positive feedback on their TH104 buccal film, indicating no further clinical trials are necessary before NDA submission.
- TH104 has shown favorable pharmacokinetics with slower absorption and delayed metabolism, potentially benefiting patients with impaired liver function.
- The 505(b)(2) regulatory pathway accelerates TH104's development for opioid-induced respiratory/CNS depression prophylaxis in military personnel and first responders.
Tharimmune, Inc. (THAR), a clinical-stage biopharmaceutical company, has released promising Phase 1 clinical data on their lead product, TH104, at Digestive Disease Week 2025. TH104, a buccal film formulation of nalmefene, has demonstrated slower absorption and delayed metabolism compared to intravenous nalmefene in healthy subjects. This unique metabolic profile may prove advantageous for patients with impaired liver function.
Following recent positive feedback from the U.S. Food and Drug Administration (FDA), Tharimmune plans to advance TH104 through the 505(b)(2) regulatory pathway for the preventive treatment of opioid-induced respiratory and central nervous system (CNS) depression. The focus is on military personnel and first responders who may face exposure to high-potency opioids. Importantly, the FDA has indicated that no additional clinical trials are needed before submitting a New Drug Application (NDA) for this indication.
The Phase 1 study conducted on TH104 showcased a comparable safety and tolerability profile to intravenous nalmefene, with only mild adverse events reported. The distinct advantage of TH104's buccal film formulation is its rapid and convenient administration, making it ideal for use in protective environments, such as those involving chemical incident responders.
In addition to its primary indication, Tharimmune is also exploring the use of TH104 in treating chronic pruritus in patients with primary biliary cholangitis (PBC), leveraging its liver-friendly metabolic profile. This development underscores Tharimmune's commitment to addressing critical unmet medical needs while delivering long-term value for its shareholders.
