Tharimmune Reports Positive Phase 1 Results for TH104

Tharimmune, Inc., a biopharmaceutical company, has announced promising data from its Phase 1 study of TH104, a nalmefene buccal film. The study assessed TH104's pharmacokinetics and metabolism in healthy subjects compared to an intravenous dose.

This research highlights TH104's slower absorption than IV administration and a unique metabolic profile. TH104 showed delayed phase 1 metabolism and increased phase 2 glucuronidation, signaling a liver-friendly profile potentially beneficial for those with liver impairments.

Following FDA's positive feedback, Tharimmune plans a 505(b)(2) submission without further trials. TH104 is positioned as a preventative measure for military and responders facing extremely potent opioids like fentanyl. Its buccal film allows easy administration in protective gear environments.