Auris Medical has announced results from a second Phase 1 study of its intranasal betahistine in 72 healthy volunteers that demonstrated superior bioavailability compared to oral betahistine for 4 doses of the nasal formulation, with plasma exposure up to 29 times higher.
A dose escalation study evaluated single doses up to 60 mg and determined the maximum tolerated dose for repeated doses at 40 mg.
Auris Medical Chairman and CEO Thomas Meyer said, “We are very pleased by the positive outcomes of the second Phase 1 trial as they confirm and validate the cornerstone of our intranasal betahistine program, which is superior bioavailability. At the same time, the study demonstrated that repeated dosing is safe, well tolerated and feasible. Based on these results, we look forward to moving ahead with our planned proof-of-concept studies in acute vertigo and olanzapine-induced weight gain.”
A Phase 1 PK/PD study of AM-201 intranasal betahistine, which Auris is developing for the treatment of olanzapine-induced weight gain, is expected to take place in the first quarter of 2019. The company also plans to initiate the Phase 2 TRAVERS trial of AM-125 intranasal betahistine in patients with acute vertigo following vestibular schwannoma resection early in 2019.
Read the Auris Medical press release.
