Sensorineural hearing loss is a major medical problem with over 32 million Americans affected. The most common form is presbycusis or aging hearing loss. Other types of hearing loss include noise exposure, genetic losses, viral and bacterial infections, ototoxic medications, autoimmune, and idiopathic. The understanding of the molecular biology responsible for hearing loss is continuing to evolve. However, the pathophysiology of many common clinical conditions is still not completely understood. There is no FDA-approved pharmacological agent for treatment of sensorineural hearing loss. This Phase I SBIR proposal involves the fabrication of therapeutic treatments for sensorineural hearing loss, with a specific focus on autoimmune inner ear disease. The specific aims of this proposal present a roadmap towards the development of intracochlear steroid formulations for the treatment of autoimmune inner ear disease. The aims of this proposal are threefold: First, the GMP manufacturing of extended release fluticasone particles. Second, sterilization and monitoring of drug release from manufactured particles over a 90 day period. Third, extended release implant formulations will be tested in animal models for safety and drug distribution in the inner ear. This will yield prototype implants that will release active therapeutic over the desired three month period. The team of investigators at O-Ray is uniquely qualified to perform the work proposed herein, and has expertise in otology, drug development and drug delivery for the successful development this product. O-Ray scientists have successfully developed therapeutic formulations that are currently being used in the clinic. This includes an intraocular sustained release steroid implant capable of maintaining anti-inflammatory intravitreal drug levels for periods of up to 3 years from a single implantation. Phase II of this project will involve the verifying the stability of these formulations, completion of chemistry manufacturing and controls for the manufactured particles, and a well-controlled safety study and in a suitable animal model in preparation for regulatory approval. The completion of this work will ultimately facilitate raising follow on venture funding or a collaboration with a corporate partner for the licensing of our developed product.
Project Terms: Address; Adverse effects; Affect; Aging; American; Animal Model; Anti-inflammatory; Autoimmune Process; Bacterial Infections; Characteristics; Chemistry; Clinic; Clinical; Clinical Research; Cochlea; Collaborations; Complication; crosslink; Crystallization; Development; Disease; Dose; Drug Delivery Systems; drug development; drug distribution; Drug Kinetics; Drug Monitoring; Environment; experience; FDA approved; fluticasone; Fluticasone propionate; Formulation; Functional disorder; Funding; Future; Genetic; Goals; Guidelines; Harvest; hearing impairment; Implant; implantation; in vivo; Individual; Industry; inner ear diseases; Investigational Drugs; Labyrinth; Licensing; Medical; Methods; Molecular Biology; Noise; novel therapeutics; Otology; ototoxicity; particle; Patients; Perilymph; Pharmaceutical Preparations; Pharmacology; Phase; phase 2 study; Phase I Clinical Trials; Polymers; preclinical study; Preparation; Presbycusis; Procedures; product development; Production; prototype; Research Personnel; Safety; safety study; Scientist; Sensorineural Hearing Loss; Small Business Innovation Research Grant; Sterilization; Steroids; Testing; Therapeutic; therapeutic development; Tissues; treatment planning; Validation; Virus Diseases; Work;
