iX Biopharma 42C has completed Phase 1 of its pharmacokinetic clinical study on the sublingual dexmedetomidine wafer it is developing.
The drug is being developed to treat dementia-related agitation, an unmet need and a condition where no drug treatment has been approved to-date.
The clinical study evaluates the safety, tolerability and pharmacokinetics of the sublingual dexmedetomidine wafers in 14 healthy volunteers, says iX Biopharma.
The first phase of the study showed “promising results” it adds, with the wafer showing 70% to 80% absolute bioavailability across all dosages tested. Bioavailability refers to the drug having an active effect upon its introduction to the body.
The wafer also achieved a peak drug concentration in 1.5 hours, with the drug detectable in plasma as early as 5 minutes post-dosing. In addition, exposure to the drug was proportional across the dosing range.
There were no serious adverse events during the study as well, says iX Biopharma.
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“These promising results validates the potential of our sublingual dexmedetomidine wafers in revolutionising the treatment of agitation in dementia patients and gives us confidence to advance this development programme," says Eddy Lee, iX Biopharma's chairman and CEO.
"With an aging global population, the prevalence of dementia continues to rise, leading to an estimated 100 million episodes of agitation per year in the USA alone. Our sublingual wafers have the potential to greatly improve patient outcomes and make a significant impact in their care,” he adds.
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.
Shares in iX Biopharma closed at 12 cents on Feb 9.
