iX Biopharma Ltd. announced the successful completion of a Phase 1 pharmacokinetic clinical study on the sublingual dexmedetomidine wafer being developed by the Company. The drug is being developed for the treatment of dementia-related agitation, which is an unmet medical need with no drug treatment approved to-date. The clinical study is a 4-way crossover study to evaluate the safety, tolerability and pharmacokinetics of the sublingual dexmedetomidine wafers in 14 healthy volunteers.

The study assessed the absolute bioavailability of sublingual dexmedetomidine wafers across the respective dosages of 30mcg, 50mcg, and 100mcg when compared to the intravenous administration of dexmedetomidine, Precedex at 20mcg. The Phase 1 pharmacokinetic clinical study achieved several promising results: High bioavailability: The sublingual wafer showed an impressive 70-80% absolute bioavailability across all dosages tested. Fast onset of action: The sublingual wafer achieved a peak drug concentration in 1.5 hours (Tmax), with drug detectable in plasma as early as 5 minutes post dosing.

Dose proportional: The drug exposure was proportional across the dosing range. Safety profile: Sublingual wafers were safe and well tolerated; there were no serious adverse events. Following the success of Phase 1, the Company plans to file an Investigational New Drug application with US Food and Drug Administration to conduct a Phase 2 study on patients with dementia-related agitation.