Blog Coverage Auris Medical Expands Clinical Development Pipeline for Treatment of Meniere’s Disease and Vestibular Vertigo

Upcoming AWS Coverage on Insys Therapeutics

LONDON, UK / ACCESSWIRE / February 6, 2017 / Active Wall St. blog coverage looks at the headline from Auris Medical Holding AG (NASDAQ: EARS) as the Company announced on February 03, 2017, that it has added a third clinical-stage development program to its pipeline and is expanding into the field of vestibular disorders. The Company is also purchasing various assets related to intranasal betahistine from otifex therapeutics Pty Ltd. Register with us now for your free membership and blog access at:

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One of Auris Medical Holding’s competitors within the Biotechnology space, Insys Therapeutics, Inc. (NASDAQ: INSY), is estimated to report earnings on February 28, 2017. AWS will be initiating a research report on Insys Therapeutics following the release of its next earnings results.

Today, AWS is promoting its blog coverage on EARS; touching on INSY. Get all of our free blog coverage and more by clicking on the links below:

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What is Betahistine?

Under the product code AM-125, Auris will develop betahistine dihydrochloride in a spray formulation for the intranasal treatment of Meniere’s disease and vestibular vertigo. Betahistine is a small molecule drug that acts as a partial histamine H1-receptor agonist and a H3-receptor antagonist. The compound has demonstrated increased cochlear, vestibular, and cerebral blood flow, vestibular compensation and the ability to inhibit neuronal firing in the vestibular nuclei. Oral betahistine is approved for the treatment of Meniere’s disease and vestibular vertigo and marketed in more than 80 countries worldwide. Since its launch, more than 130 million patients have been prescribed betahistine. However, betahistine has not been approved for marketing in the United States for the past few decades.

“We are excited to add AM-125 to our development pipeline as it addresses important unmet medical needs in vestibular disorders and serves as a strategic fit with our existing projects,” commented Thomas Meyer, Auris Medical’s founder, Chairman and Chief Executive Officer, “While oral betahistine has been a mainstay treatment for Meniere’s disease and vestibular vertigo for many years and in many countries around the world, we expect the novel approach of intranasal delivery to offer significant additional benefits in terms of efficacy and tolerability.”

Meniere’s disease is a chronic disorder of the inner ear characterized by episodes of vertigo, ringing in the ears, hearing loss, and fullness in the ear. According to the National Institute of Deafness and Other Communication Disorders, there are more than 600,000 American adults currently diagnosed with Meniere’s disease and no therapies currently approved by the US Food and Drug Administration.

Purchase of Assets

Auris Medical stated that it has entered into an agreement with Otifex Therapeutics to purchase various assets related to intranasal betahistine, including preclinical and clinical data as well as certain intellectual property rights. In a Phase-1 trial conducted by Otifex, intranasal betahistine showed good tolerance and a significantly higher bioavailability than reported for oral betahistine administration. Auris Medical plans to initiate a second Phase-1 trial in 2017.

Resumes TACTTT3 Phase-3 Trials

On January 26, 2017, Auris announced that it has resumed patient enrolment in the TACTT3 Phase-3 trial of Keyzilen® (AM-101) in acute and post-acute inner ear tinnitus.

TACTT3, which is being conducted in Europe, is a randomized, double-blind, placebo-controlled Phase-3 trial in inner ear tinnitus following traumatic cochlear injury or otitis media. The trial previously enrolled more than 300 patients during the acute tinnitus stage (Stratum A) and approximately 330 patients during the post-acute tinnitus stage (Stratum B). The TACTT3 protocol was amended based on analysis of the TACTT2 Phase-3 trial outcomes. The amended protocol elevates the Tinnitus Functional Index score from a key secondary endpoint to an alternate primary efficacy endpoint, includes certain patient subgroups in confirmatory statistical testing and increases the trial size with the enrolment of an additional 60 patients in each of Stratum A and B.

Stock Performance

At the closing bell, on Friday, February 03, 2017, 2017, Auris Medical’s stock climbed 1.71%, ending the trading session at $1.19. A total volume of 67.82 thousand shares were traded at the end of the day. In the previous three months, shares of the Company have advanced 19.00%. Moreover, the stock surged 11.21% since the start of the year.

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