Preclinical and Clinical Therapeutics for Noise-Induced Hearing Loss
Abstract
Noise-induced hearing loss (NIHL) significantly affects Service Members in daily life and on battlefields. Despite the health, economic, and societal impact of NIHL, no drugs have been approved by the Food and Drug Administration (FDA) to prevent or treat such hearing loss. We have performed three novel computer-based drug screens to identify candidate otoprotectants against ototoxic insults of noise, cisplatin, or antibiotics. We have identified 33 FDA-approved drugs for clinical indications other than hearing loss. Repurposing these FDA-approved drugs as candidate otoprotectants can expedite the FDA approval process with approximately half the cost and time. This is because their safety and kinetic profiles have already been well-characterized in both preclinical and clinical studies. Unsurprisingly, the number of repurposed FDA-approved drugs has surpassed that of new chemical entities since 2003. Niclosamide is the top drug identified in our screens that has been FDA-approved for > 4 decades for gut-worm treatment in humans. Here we have confirmed in preclinical animal models that niclosamide protects against NIHL effectively. Here we aim to develop niclosamide to be one of the first FDA-approved drugs for NIHL treatment that will significantly benefit our Service Members as well as the general population. Our study will validate our preclinical results in a second preclinical animal model that has been widely accepted for otologic studies by FDA, thus accelerating the translation of preclinical studies to clinical therapies. A provisional patent application has been filed for niclosamide s protection against hearing loss in humans by the Principal Investigator (PI) through Creighton University. Upon accomplishment of these aims, we will further execute our commercialization plan through our recently established private biotech startup company, Ting Therapeutics LLC, founded by the PI.
Document Details
- Document Type
- DoD Grant Award
- Publication Date
- Dec 05, 2021
- Source ID
- W81XWH2110556
Entities
People
- Jian Zuo
Organizations
- Creighton University
- United States Army