Novear Therapeutics LLC — Department of Health and Human Services SBIR Phase I: NIDCD

Description

Noise induced hearing lossNIHLis a common cause of hearing loss in adults in Western industrialized countriesAccording to the latest National Institute of Deafness and Communication DisordersNIDCDreportnearly one in fourpercentof U Sadultstoyears of agehave features suggestive of NIHLWithin the military populationan estimatedof veterans returning home from war have hearing lossCDCAccording to Veterans AffairsVAnoise induced hearing injuriesNIHIare costly and a health concern for former and current armed forces service membersVeterans Affairs disability compensation for NIHL are currently over $billion per yearHearing loss has been linked to feeling of frustrationdepressionsocial isolationand in severe casescognitive decline and brain shrinkageThusthere is an urgent unmet need for viable treatments and preventative measures that would be readily accessible and applicableCurrent rehabilitation options include the use of powerful hearing aids or highly invasive cochlear implant surgery for patientsneither of which are effective treatmentsThere are several anti oxidant steroid supplemental vitamin clinical trials underway that target the oxidative stress pathway induced in NIHLSome of these drugs show prevention of temporary threshold shift immediately after noise exposureHoweverthere are no studies that show successful treatment and restoration of NIHLCurrentlythere are no FDA approved drugs in the market to treat NIHLThis STTR phase I proposal will be used to investigate the feasibility of re purposing two clinically used FDA approved drugs for the treatment of NIHLThe combination of these drugswhich we name NTshould allow for more rapid entry into clinical use as the safety profile of the individual drugs are already established in humansNTcombines two anti inflammatory drugs that inhibit two different targetsimplicated in NIHLPreliminary data indicate that each agentwhen used alonecan reduce NIHLHoweverwhen given in combination it not only prevents NIHLbut significantly restores hearing after permanent hearing loss has already been established in the rat modelThe specific aims of the project areTo determine the dose response of the drug combination in preventing NIHLandto determine the feasibility and window of opportunity for using NTto restore hearing when administered following establishment of NIHLSuccessful completion of these studies will help define the effective dose range of NTthat will preserve at leasthearingpreservation of ABR wave I amplitude andpreservation of intact synapses IHC in the NIHL rat modelThe window of opportunity will establish the time limit after traumatic noise exposure wherein NTtreatment will be able to restorehearingThe data generated from these experiments will be critical for the initial Investigational New DrugINDfiling under an expedited regulatory path for repurposed drugs for future studies of NTin humansFuture Phase II studies will focus on reformulationadditional animal testingand toxicology studies Project Narrative Noise induced hearing loss is common condition with no available treatment optionsthat carries the price tag of a whopping $billion dollars in economic burden to the society in the United States aloneThis Phase I STTR application sets out to repurposeFDA approved drugs for noise induced hearing lossBoth these agents target different cellular mechanisms involved in the hearing loss pathway ultimately leading to the development of a combination drug that will treat and possibly restore noise induced hearing loss