Auris Medical Holding AG, a Swiss biopharmaceutical company dedicated to developing therapeutics to treat inner ear disorders, announced on February 24 that the US Food and Drug Administration (FDA) has granted Fast Track designation for AM-111 in the treatment of acute sensorineural (inner ear) hearing loss (ASNHL).
“We are very pleased to have received Fast Track designation for AM-111 from the FDA,” said Thomas Meyer, Auris Medical’s founder, chairman and CEO, in a press release. “The designation recognizes that acute sensorineural hearing loss can be a serious condition with a significant impact on day-to-day functioning. It may develop into irreversible, chronic hearing loss with debilitating consequences, yet there is no therapy available for ASNHL that is approved or that has shown clear evidence of therapeutic benefits.”
Auris Medical is evaluating AM-111 in two Phase 3 clinical trials. The first is the HEALOS trial, which is being conducted in several European and Asian countries. HEALOS aims to enroll approximately 255 patients with severe to profound idiopathic sudden sensorineural hearing loss. The company expects to complete enrollment in the second quarter of 2017 and announce top-line results from this trial in the third quarter of 2017.
The second is the ASSENT trial, which is being conducted in the United States, Canada, and South Korea. ASSENT aims to enroll approximately 300 patients with severe to profound idiopathic sudden sensorineural hearing loss. Auris Medical expects to announce top-line results from this trial in the second half of 2018.
According to Auris, AM-111 contains the synthetic peptide brimapitide, a cell-penetrating inhibitor of the JNK stress kinase. By blocking JNK, AM-111 protects stress-injured cochlear cells and helps to prevent or reduce chronic hearing loss. AM-111’s otoprotective effects have been demonstrated in various animal models of cochlear stress, including acute acoustic trauma, acute labyrinthitis (inflammation), drug ototoxicity (aminoglycosides), bacterial infection, cochlear ischemia, and cochlear implantation trauma.
“We welcome the opportunity to work closely with the FDA to expedite the development of AM-111 and look forward to reporting our first top-line results from the Phase 3 program in the third quarter,” said Auris Medical’s Head of Regulatory and Quality Affairs Andrea Braun.
The FDA’s Fast Track program was created to facilitate the development and expedite the review of new drugs that are intended to treat life-threatening conditions for patients with unmet medical needs. A drug that receives Fast Track designation is granted more frequent access to the FDA to review the drug’s development plan and may become eligible for priority review if relevant criteria are met.
Source: Auris Medical