FDA Fast Tracks Review of AM-111

More hope on the horizon for those of us suffering from sensorineural hearing loss.  Auris, a Swiss biopharmaceutical company, is developing a promising drug called AM-111.

It’s now in clinical trials and the U.S. Food and Drug Administration has just approved it for a “Fast Track” designation.  That means it will now undergo a speeded up review process.

I will be following this development closely.  More reports to come. Meanwhile, here’s the company’s press release:

Zug, Switzerland, Feb. 24, 2017 – Auris Medical Holding AG (NASDAQ: EARS), a clinical-stage company dedicated to developing therapeutics that address important unmet medical needs in otolaryngology, today announced 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,” commented Thomas Meyer, Auris Medical’s founder, Chairman and Chief Executive Officer. “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 ASHNL that is approved or that has shown clear evidence of therapeutic benefits.”

Auris Medical is currently 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. Auris Medical 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 US, 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.

“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,” commented Andrea Braun, Auris Medical’s Head of Regulatory and Quality Affairs.

The Fast Track program was created by the FDA to facilitate the development and expedite the review of new drugs that are intended to treat serious conditions and fill an unmet medical need. The program’s purpose is to get important new drugs to the patient earlier. 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. Additionally, Fast Track designation allows the sponsor to submit parts of the New Drug Application (NDA) for review on a rolling basis as data become available.

3 thoughts on “FDA Fast Tracks Review of AM-111”

  1. Hi there,

    Can’t tell you how much I appreciate these updates. Do you think that sense they are only looking at people with sudden hearing loss to do the trials that this drug would only help people who have suffered that kind of loss or might it be useful to anyone with sensorineural hearing loss?

    Thanks for your thoughts.

    1. The trials are focussed on people who have suffered what Auris calls, “stress-injured cochlear cells”. Those injuries can be caused by very loud noises, drugs such as certain antibiotics, infections, inflammations and from cochlear implant surgery. And, yes, they consider it a potential treatment for idiopathic (sudden) hearing loss. However, the research certainly will lead to a greater understanding of hair cells in general, and AM-111 may have other uses. After all, viagra was originally developed as a heart drug.

  2. Am-111 is specific to ASNHL only. So I do not expect.
    CGF-166, which can solve the general sensorineural hearing loss, is expected more.

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