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with various methods of delivering drugs to the ears for various conditions, Lichter says. If everything breaks right, Otonomy could enter its first clinical trial a year from now. Lichter says he’s currently attempting to parlay this work into $20 million in a Series A financing, which he hopes to close in two to three months.
One of the initial product candidates is aimed at Meniere’s disease, which currently affects about 615,000 people in the U.S., according to the National Institutes of Health. The existing treatments for this condition are diuretics, and putting patients on a low-salt diet, which is hard to stick with, Lichter says. When that doesn’t work, patients sometimes take oral corticosteroid drugs that circulate through the body, although they only work about one-third of the time, Lichter says.
Otonomy’s idea is to make a gel formulation of a common corticosteroid drug, dexamethasone, that can be injected directly into the ear, Lichter says. The main advantage is that it can last several days, much longer than current formulations. The raw materials are cheap, and well-understood by the FDA from experience in numerous clinical trials with other drugs, which lowers the risk of regulatory delays, he says. By giving concentrated doses of the steroid directly into the ear, it is hoped that the Otonomy drug will be more effective, and also avoid some of the side effects associated with long-term use when these drugs circulate throughout the body, like weakening of the immune system, weight gain, and thinning of the bones.
This could also have a much bigger application than Meniere’s disease—noise-induced hearing loss. Otonomy has been encouraged to go down this path by some data published in December 2007 on soldiers in the Greek Army. The study looked at 52 young soldiers who were exposed to intense gunfire noise. They were divided into three treatment groups: those who got intravenous steroids within an hour of exposure, between one hour and 16 hours, or a full 24 hours later. The study showed 65 percent had complete recovery of their hearing when they got the treatment within an hour of damaging exposure to noise. The response rate that went downhill if it took longer for the soldiers to get treatment, researchers said.
Further in future, Otonomy has its eyes on other opportunities as well—including middle ear infections commonly found in children (otitis media), and age-related hearing loss, which is found in about one-third of all adults between the ages of 65 and 75.
There are only a couple of competitors to Otonomy: Seattle-based Sound Pharmaceuticals and Basel, Switzerland-based Auris Medical. Both of them have programs further along in the middle stage of clinical trials. They have continued to push forward after two biotech leaders, Amgen and Genentech, had hearing loss research programs in the late 1990s and early 2000s that failed, said Sound Pharmaceuticals CEO Jonathan Kil. That experience has made most drug companies in the field back off, he says.
“Big Pharma is actually risk averse,” Kil says. “They’d rather go after a validated market and out-market their competition with a second or third generation product versus truly innovate in a new therapeutic area.”
For those who do actually create something innovative, the rewards could be big. Otitis media alone costs the nation $5 billion a year in medical costs and lost wages from parents shuttling kids to the doctor, according to the NIH. “You don’t need a lot of market penetration, or a very high price to make for really interesting products,” Lichter says.
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