The Food and Drug Administration (FDA) has granted Fast Track designation for AM-111 (Auris Medical) for the treatment of acute sensorineural hearing loss (ASNHL). 

AM-111 is currently under investigation in two Phase 3 trials for patients with severe to profound idiopathic sudden sensorineural hearing loss in several European and Asian countries (HEALOS study) and in the US, Canada and South Korea (ASSENT study). Results for these studies are anticipated in the third quarter of 2017 and the second half of 2018, respectively.

AM-111 is a single dose, intratympanic formulation of the synthetic peptide brimapitide (D-JNKI-1), a cell-penetrating JNK stress kinase inhibitor. AM-111 protects stress-injured cochlear cells and helps to prevent or reduce chronic hearing loss via the inhibition of JNK, a key component in the apoptosis of cochlear hair cells and neurons as well as in inflammatory responses.

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