Archive: Future hope for Ménière’s, tinnitus and hearing loss

Posted By on January 12, 2015

As a conservative … politically, I probably don’t give enough credit to the Old Gray Lady for their often excellent articles covering content outside of politics. menieresdizzyThis weekend was no exception and I wanted to archive an article which has personal interest … and is something I’d like to look in to as an investor too. I’ve dealt with Ménière’s disease and its long term impact on my day to day life since the late 1990s. Thankfully, having just hearing loss and tinnitus is tolerable nowadays, but the vertigo in those early years was intolerable. Ugh, bad memories.

Auris Medical Hldng – EARS $3.61 1/9/2015 close
Otonony, Inc – OTIC   $33.25 – 1/9/2015 close

Companies are also working on drugs for tinnitus, in which sound is perceived without a source of the sound being present. Roughly 10 percent of American adults, or 25 million people, have experienced at least one episode lasting five minutes or more in the last year, according to the National Institute on Deafness and Other Communication Disorders.

Tinnitus can be caused by many things, including hearing loss. Treatments include behavioral therapy and devices that can mask the sound. But many of those just help people tolerate the condition, not get rid of it. Some drugs like steroids and lidocaine are used off label.

Auris is in late-stage trials of AM-101, a derivative of the anesthetic ketamine, which it hopes will dampen the aberrant signaling in the auditory nerve that is perceived as tinnitus. In a midstage trial, the drug, injected into the middle ear, was not more effective overall than a placebo. But a subset of patients whose tinnitus was caused by trauma or infection said the drug made the sound in their ears softer, less annoying and less disruptive of sleep.

Investors appear to be cautious given the challenges. Auris went public on Nasdaq in August at $6 a share, using the trading symbol EARS. The stock is now trading at about $4.

Otonomy’s stock, by contrast, has roughly doubled since its August initial public offering. That is perhaps because for now it is pursuing what might be more tractable problems.

When Mr. Lichter suffered his first attack of Ménière’s, he received steroids, a commonly used off-label treatment. But when the drug is injected into the middle ear, patients have to lie on their sides for 30 minutes and not swallow to try to keep the drug from draining into the throat through the Eustachian tube.

Otonomy, based in San Diego, developed a way to deliver the steroids as a gel that does not readily drain away after injection. The company has started the final stage of trials for the Ménière’s product. It hopes its first product — it will apply for regulatory approval in the first half of this year — could be a gel form of an antibiotic to be injected to treat middle ear infections, an alternative to ear drops.

Mr. Lichter said the intense bouts of vertigo, which left him bedridden two or three times a week, have not returned in four years. But he has constant ringing in his left ear and can barely hear through it.

Mr. Lichter, a managing director at Avalon Ventures in San Diego, said that although he had helped start 15 or 20 companies, “This is the one that is special to me.”

Full New York Times article

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