There is huge opportunity for companies looking for a money maker! According to the World Health Organization, there are more than 360 million people with disabling hearing loss who need help. Currently, we work to fit these individuals with hearing aids and teach others about reducing noise exposure. But what if we could develop a way to regrow the damaged area in the hearing organ after noise exposure? What if we can use eardrops that will prevent hearing loss before it happens? Both of these ideas and others are being examined by various scientists.
Getting the Drug into the Inner Ear
Third Rock has created a venture team named Decibel that has been researching a drug design and how to deliver the drug into the inner ear. Because the size of the hearing organ is so small and there is such variability in ear canals, tympanic membranes and how each person perceives sound we know that this is going to be a challenge. This group is developing a more complete understanding of the source of hearing disorders in addition to the treatment. They spent $3.5 million on the initial research and now have invested $52 million in the more focused area that Decibel is working on. One of the first projects is to develop a drug to prevent hearing loss in children who take powerful antibiotics called aminoglycosides. These drugs are given to treat children with cancer and infections in people with cystic fibrosis.
Protect Hearing with Sustained Release Medication
Otonomy is a biotech company working on a sustained-release formulation of the steroid dexamethasone named OTO-104. Their drug would be used on children and adults undergoing chemotherapy. The phase 1 trial of OTO-104 will begin near the end of 2016. This drug is administered through the eardrum, similar to the current medication Otiprio after PE tubes are surgically placed.
Protecting the Hearing Proactively
Oricula has recently secured government funding to develop ORC-13661, which is a drug-like small molecule that might alter the response of hair cells of the inner ear to ototoxic medications. It has been shown to protect hearing in rats after they are given antibiotic aminoglycoside amikacin. Hearing loss is a common side effect of this antibiotic but the medication is necessary to treat resistant bacterial infections. Human trials are scheduled to begin in early 2018. These tests will only involve human volunteers exposed to ORC-13661, but not to AG antibiotics. The purpose is to demonstrate the safety of the drug in humans and to estimate the appropriate dose to test in actual clinical trials. They will be working to identify the appropriate clinical indication for the initial testing of ORC-13661 as a hearing protectant.
There is movement in the field of research to find a cure or at least reduce the loudness of the noise a person hears in either their ears or head (tinnitus) Autofony Therapeutics was working on a potassium channel modulator but recently revealed that the data was not showing the drug to be effective. Auris Medical is doing a phase II study on a drug called N-methyl-d-aspartate. The initial results are promising. People who take the drug over three days experienced a significant reduction in the loudness of the tinnitus compared to the individuals given placebo.
The idea behind gene therapy is to restore hearing in people with severe hearing loss. Novartis developed a gene therapy aimed to regenerate the inner hair cells. The medication was surgically placed deep into the hearing organ. The results are disappointing. The recipients usually experienced brief bursts of improved hearing but it was not sustainable. The enrollment was paused while they collect additional data on safety for individuals who already received the therapy.
The Core of the Issue
Historically, a person is told they have a hearing loss but the location, cause and anatomical changes are not currently measurable conditions. The gene therapy assumes that all the individual needs is to have the hair cells regrown. We do not know if the hearing is impaired because of damaged hair cells in the hearing organ or because of a problem in how the sound signals are processed in the brain. Is there a genetic reason or even blood flow interruption? Perhaps the person has a hearing loss as a side effect of medications being taken. Ideally, we need to find the problem area then tease out how the damage occurred and finally create person specific assistance. FBN
By Dr. Karon Lynn, Au.D