The AuraquellTM Product

The Company’s lead product, called AuraquellTM, is a combination of vitamins A, C, E, and magnesium.  Whereas each individual agent has shown only small protective effects with long-term dosing, the AuraquellTM combination significantly reduces noise induced hearing loss (NIHL) with treatment initiated as little as 1 hour prior to noise exposure.  The four active ingredients in AuraquellTM, each have a distinct mechanism of action.  Vitamins A, C, and E are antioxidants, while magnesium acts as a vasodilator and may have the additional beneficial effect of reducing swelling of the auditory nerve by preventing noise-induced calcium influx.   

OtoMedicine’s product development and market penetration strategies for AuraquellTM are unique in the industry.  All of its active ingredients are regarded as safe in humans and are not considered new drug entities.  Thus, AuraquellTM will be regulated in the US by the FDA’s Dietary Supplement Health and Education Act of 1994 (DSHEA), and label claims for the product will be made following 21 CFR 101.70 regulations, and not through the IND/NDA process (see links for DSHEA and 21 CFR 101.70).  This will allow OtoMedicine; to launch AuraquellTM with defined and FDA-approved health claims in a far shorter time (4-5 years), and to reduce the risk and expense of bringing the product to market because clinical safety trials, and regulatory filings and reviews will be minimal in comparison to those for a new drug compound.  This strategy will also allow AuraquellTM to distinguish itself as superior to other over-the-counter nutraceutical products currently being sold without clinical data or health claims.   

Currently, there are no therapeutic products on the market that have demonstrated protection against NIHL in human clinical studies.  There is significant market interest for a treatment for NIHL, like AuraquellTM, that will not be drug based, so as to not require prescriptions for generally healthy employees and to not increase medical costs significantly.   AuraquellTM will be a preventative treatment that can be used in conjunction with physical hearing protection, such as earplugs and earmuffs, and will be readily accepted by the market for daily use because of its safety profile and low cost per dose.

Swedish Military Impulse Noise Study (SMINS)

Swedish soldiers undergoing urban warfare training are exposed to the sound of rapid, repeated gunfire in bunkers, in which sound reflects off concrete walls and noise levels are enhanced.  Standard hearing protection, which the soldiers are required to wear during this training, does not provide sufficient protection, and significant temporary hearing losses are experienced by the soldiers after the training.  Although the gunfire causes temporary hearing loss, there is some evidence suggesting repeated temporary hearing loss can result in permanent hearing loss.  Additional anecdotal evidence for this comes from soldiers exposed to automatic weapons noise in a preliminary study with the Swedish military.  These soldiers had significant permanent hearing loss at the start of the study and the temporary hearing loss produced during the shooting exercises was at the same frequencies as the soldiers’ permanent hearing loss.  Because of this, the Swedish military has agreed to allow additional access to soldiers required to participate in automatic weapons training, in order to test Auraquell™ for prevention of the gunfire-induced hearing loss.  

The soldiers will be treated with high-level doses of Auraquell™ prior to the weapons training and specific measures of hearing loss will be tested before and after the noise exposure.  Clinical supplies will be produced by The Chao Center, in West Lafayette, Indiana (see link for The Chao Center).  Hearing testing will include; pure-tone audiogram measurement, psychoacoustical modulation transfer function (PMTF), which will provide a powerful measure of the person’s ability to discriminate speech in noise, and distortion product otoacoustic emissions (DPOAEs), which will provide a sensitive and objective measure of outer hair cell function.  Outer hair cells in the cochlea are particularly sensitive to noise-induced damage.  The extent to which Auraquell™ reduces the transient hearing loss will provide key data as to whether Auraquell™ can reduce temporary hearing loss, as well as the permanent hearing loss demonstrated with guinea pigs.  Success in this study will provide proof-of-concept for human efficacy of the product.

National Institutes of Health Small Business Innovative Research Project

National Institutes of Health (NIH) has funded a Phase I, Small Business Innovative Research (SBIR) project at OtoMedicine, Inc., which will investigate whether NIHL and age-related hearing loss (ARHL) are linked by common biological pathways that are protected by AuraquellTM treatment.   Numerous studies have linked long-term noise exposure to an increased prevalence of ARHL.  Because of this commonality for reduction in hearing ability over time from noisy environments and/or genetics, it is postulated that there are common pathways for hearing loss resulting from noise and aging.  Intervention at these common pathways may prevent ARHL.  The proprietary combination of compounds, AuraquellTM, will be tested for efficacy in an ARHL mouse model.  This model provides for short-period aging of hearing function that can be accelerated by noise exposure, as is the case with humans.  The combination has been demonstrated in guinea pigs to be effective at significantly reducing NIHL.  If the NIHL pathways affected by treatment with AuraquellTM are common to both NIHL and ARHL, then treatment should also demonstrate a decrease in parameters for ARHL in the mouse model.

In phase I, AuraquellTM will be demonstrated to be effective in reducing NIHL in the mouse model.  In phase II of the SBIR project, the extent to which the product prevents age-related hearing loss (ARHL) in the mouse model will be ascertained.  Because ARHL in humans is a problem that manifests itself over many years, use of the mouse model will provide a rapid means of demonstrating the applicability of AuraquellTM for prevention of ARHL.  The analytical aspects of the studies will include analysis of hearing reduction and physiological loss of hearing capacity through histology (i.e., destruction of hair cells and neurons).  The phase II protocol will include experimental groups with and without loud noise exposure.  Demonstration of reduced ARHL by AuraquellTM in both unexposed and noise-exposed groups will allow for optimization of human clinical study protocols by allowing us to target key subject groups.  The ultimate goal for this project will be to commercialize AuraquellTM for prevention of ARHL.  A label claim for prevention of ARHL will expand the market for the product to the general population.