EARS unveils AM-111 Phase 3 trial outcomes in a peer-reviewed article
Category: #health  By Pankaj Singh  Date: 2019-03-12
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EARS unveils AM-111 Phase 3 trial outcomes in a peer-reviewed article

Auris Medical Holding AG (EARS), a Switzerland-headquartered pharmaceutical company, has reportedly announced the publication of a peer-reviewed scientific article which contains detailed outcomes of the HEALOS Phase 3 trial with AM-111. AM-111 for the record, is the investigational treatment developed by Auris Medical for severe inner ear hearing loss.

Reportedly, the article that discusses the efficacy & safety of AM-111 in the treatment of unilateral sudden deafness in randomized, placebo-controlled Phase 3 study, has been published in one of the leading scientific journals in the field of clinical inner ear research, named Otology & Neurotology.

Hinrich Staecker, PhD, MD, University of Kansas Medical Center, who is also the lead author of the book, was quoted stating that the HEALOS trial shows that the right hearing protection can be possible through a drug-based approach, even in case of acute hearing loss, with poor prognosis for recovery and high risk of cognitive disability. He went on to say that treating with a single dose of AM-111 led to a clinically profound hearing recovery in the trial and marked the signs of improvement and moreover, he affirmed that the outcomes appear to be quite promising.

According to a press release by Auris Medical, the HEALOS trial was conducted in several Asian and European countries and enrolled around 256 patients victimized by severe, sudden deafness. The patients were reportedly randomized in a 1:1:1 ratio for receiving a single dose of AM-111 0.8 mg/mL, AM-111 0.4 mg/mL or placebo, to be administered in the middle ear. However, the trial did not meet the prime efficacy endpoint in the entire study population but, the post-hoc analyses showed significant improvement with AM-111, right from the baseline to Day 28.

For those uninitiated, AM-111 is developed with a biocompatible gel formulation for treating sudden sensorineural hearing loss. It holds an orphan drug designation (ODD) from both the European Medicines Agency (EMA) and US FDA (Food & Drug Administration) and was granted a Fast Track status by the FDA.



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Pankaj Singh

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Pankaj Singh

Pankaj Singh Develops content for Market Size Forecasters, Algosonline, and a couple of other platforms. A Post Graduate in Management by qualification, he worked as an underwriter in the UK insurance domain before deciding to switch his field of profession. With exp...

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