Auris Medical Holding AG (NASDAQ:EARS) Second Phase 1 Trial Demonstrates Superior Bioavailability Over Betahistine Dosage


Auris Medical Holding AG (NASDAQ:EARS) recently announced its second Phase 1 trial positive results that evaluated the effect of intranasal betahistine on healthy volunteers. As per the report, the study results of the clinical-stage company engaged in developing drugs that address unmet neurotology and mental health supportive care needs, demonstrated superior bioavailability.

The study results evaluated the effect over a range of doses of four intranasal betahistine as compared to the oral betahistine with the exposure to plasma going 6 to 29 times higher. The study also confirmed the intranasal betahistine’s good safety profile showing that the volunteers tolerated the treatment well when administered three times every day for three days in a row.

Michaelides says second Phase 1 trial results look promising

According to the Yale School of Medicine’s Associate Professor of Surgery, Otolaryngology, and Director of the Hearing and Balance Program, Elias Michaelides,” The results from the phase 1 trial with intranasal betahistine appear very promising. While oral betahistine can be quite useful in vertigo management, its therapeutic potential is clearly restrained by poor bioavailability. Intranasal betahistine seems to address and overcome this limitation very effectively.”

He further added that the company is happy with the positive outcomes of the second Phase 1 trial because they confirmed and validated the cornerstone of their intranasal betahistine program. The Founder, Chairman, and CEO of Auris Medical, Thomas Meyer commented that the study demonstrated successfully the feasibility, safety, and tolerance for the dosage. He further added that on the basis of these results the company is looking forward to moving ahead following its plans related to proof-of-concept studies in the olanzapine-induced weight gain and acute vertigo.

Company has new plans for first quarter of next year

As per a report, the company is planning to start proof-of-concept studies with intranasal betahistine on two randomized double-blind placeboes after the success of the second Phase 1 trial in the first quarter of next year. In its “TRAVERS” Phase 2 clinical program Auris is planning to enroll patients with acute vertigo caused after vestibular schwannoma resection.

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