a twice-daily oral form of epselen (SPI-1005). It’s a small molecule designed to mimic the activity of an enzyme in the inner ear, glutathione peroxidase. After a trauma, like a head blow or exposure to loud music, production of this enzyme goes down. The enzyme can rebound on its own, but when people continue to encounter loud music during the vulnerable period, hair cells in the inner ear can be irreparably injured and die, Kil says.
The trial itself has been designed to get a fast answer. It shouldn’t be too hard to find young people who listen to loud music (duh), especially since they will get some compensation for participating. The subjects only need 14 days of follow-up, since the study is only looking at temporary hearing loss. Data could arrive as soon as December, Kil says.
Sound Pharma has more than just this one drug—a second candidate is in clinical testing for chemotherapy-induced hearing loss, Kil says. But fighting hearing loss in young people with an oral pill is the bigger potential market, partly because of the scope of the problem, and partly because a safe and effective pill ought to be an attractive option. After all, how cool is it to be a young adult wearing a hearing aid?
Big Pharma companies haven’t shown much interest in this market yet, but Sound Pharma isn’t the only startup moving ahead. San Diego-based Otonomy announced in August that it raised $38 million in venture capital to develop a long-lasting corticosteroid gel that gets injected into the inner ear to suppress inflammation. Switzerland-based Auris Medical is another competitor.
Learning what he has about hearing loss, Kil says he personally refuses to use a digital music player with earbuds, and usually only listens to music in the car. He wears earplugs on cross-country flights, or when traveling in noisy environments. (I will confess he influenced me to run out to Bartell’s and pick up some earplugs for my next long flight, and to remember to keep the volume down on my portable music player).
Teens, of course, tend to think of themselves as bulletproof when it comes to health matters, so Sound Pharma is thinking about other patient groups, too. Now that the leading edge of the baby boomers has turned 65, hearing loss has arrived on the radar screens of more and more investors, he says. Hearing aid technology has improved, and become less visible, but hearing aids are still expensive, and people remain self-conscious about getting them, Kil says. It all says to Kil there’s room in the market for an oral therapy, and he says more investors are coming around to the idea.
“It seems like in last year, there has been more attention paid to diseases of aging, including hearing loss, when people look at neurological disease portfolio, hearing loss is percolating to the surface,” Kil says. “Hearing loss is the largest opportunity in CNS (central nervous system) disorders, by far. It’s three times as common as visual loss. Some people are starting to ask, ‘Why are we not invested in it?'”