Auris Medical

Therapeutics for
inner ear disorders

Development status

AM-125 for the treatment of vertigo is expected to complete its Phase 2 TRAVERS trial in Q4 2021 and to move into Phase 3 in 2022. Keyzilen® (AM-101) for the treatment of acute inner ear tinnitus and Sonsuvi® (AM-111) for the treatment of acute inner ear hearing loss have both been evaluated in Phase 3 trials, but will require further clinical testing. 

Overview of key studies

StudyStudy DesignStatus
AM-125 Phase 1 trial (1)

Dose escalation in healthy volunteers, single dose, placebo controlled (n=40)

Completed
AM-125 Phase 1 trial (2)

Dose escalation in healthy volunteers, single dose and 3 doses per day for 3 days, placebo controlled (n=72)

Completed
AM-125 Phase 2 trial (TRAVERS)

Treatment of patients suffering from acute vertigo following neurosurgery with 3 doses per day for 4 weeks, followed by 2 weeks of treatment-free period, placebo controlled (n=118)

Ongoing

Preclinical and clinical evidence

Superior bioavailability

Intranasal delivery of betahistine results in 5 to 29 times higher plasma exposure compared to standard oral administration.

Accelerated and improved balance function

Dose dependent improvement in balance for neurosurgery patients suffering from acute vertigo

Current clinical investigations

For participation in a clinical investigation with AM-125, please check the following information resource:

© Altamira Therapeutics

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