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Auris (EARS) Advances on Sudden Deafness Study, Stock Up
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Auris Medical Holding AG shares were up 15.2% after the company announced that it has attained enrollment midpoint (n=125) in the phase III HEALOS study on AM-111 for the treatment of idiopathic sudden sensorineural hearing loss (ISSNHL), also known as sudden deafness.
HEALOS is evaluating the safety, efficacy and tolerability of a single-dose intratympanic administration of AM-111 (0.4 mg/mL and 0.8 mg/mL), in comparison to placebo, in patients suffering from severe to profound ISSNHL, within 72 hours from onset.
We note that the HEALOS study is being conducted in several European and Asian countries. Top-line data from the study are expected in the second half of 2017.
AM-111 is also being assessed in a phase III study – ASSENT – for the same indication. Top-line results are expected in the first half of 2018.
We are encouraged by the company’s progress on AM-111. The candidate enjoys orphan drug status in both the U.S. and the EU for the treatment of acute sensorineural hearing loss (ASNHL).
Meanwhile, Auris is evaluating another candidate, Keyzilen (AM-101) in a phase III study, TACTT3, for the treatment of acute inner ear tinnitus. Top-line results from this study are expected in the fourth quarter of 2016.
We note that both acute inner ear tinnitus and hearing loss are conditions that have significant unmet medical need. Considering the lack of approved treatments targeting these conditions, both Keyzilen and AM-111 could be the first treatments for these indications, upon successful development and subsequent approval.
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Auris (EARS) Advances on Sudden Deafness Study, Stock Up
Auris Medical Holding AG shares were up 15.2% after the company announced that it has attained enrollment midpoint (n=125) in the phase III HEALOS study on AM-111 for the treatment of idiopathic sudden sensorineural hearing loss (ISSNHL), also known as sudden deafness.
HEALOS is evaluating the safety, efficacy and tolerability of a single-dose intratympanic administration of AM-111 (0.4 mg/mL and 0.8 mg/mL), in comparison to placebo, in patients suffering from severe to profound ISSNHL, within 72 hours from onset.
We note that the HEALOS study is being conducted in several European and Asian countries. Top-line data from the study are expected in the second half of 2017.
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AM-111 is also being assessed in a phase III study – ASSENT – for the same indication. Top-line results are expected in the first half of 2018.
We are encouraged by the company’s progress on AM-111. The candidate enjoys orphan drug status in both the U.S. and the EU for the treatment of acute sensorineural hearing loss (ASNHL).
Meanwhile, Auris is evaluating another candidate, Keyzilen (AM-101) in a phase III study, TACTT3, for the treatment of acute inner ear tinnitus. Top-line results from this study are expected in the fourth quarter of 2016.
We note that both acute inner ear tinnitus and hearing loss are conditions that have significant unmet medical need. Considering the lack of approved treatments targeting these conditions, both Keyzilen and AM-111 could be the first treatments for these indications, upon successful development and subsequent approval.
Auris currently has a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include Pacira Pharmaceuticals, Inc. (PCRX - Free Report) , Corcept Therapeutics Incorporated (CORT - Free Report) and ANI Pharmaceuticals, Inc. (ANIP - Free Report) . All three stocks sport a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
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