The U.S. Food and Drug Administration (FDA) gave a green light to human testing of ORC-13661, Oricula Therapeutics‘ treatment candidate to prevent hearing loss in people taking high doses of aminoglycoside antibiotics, including patients with cystic fibrosis.
Approval given the company’s Investigational New Drug Application will enable Oricula to test the safety, tolerability, and pharmacokinetics (the effects of the body on a drug) of ORC-13661 in volunteers.
Aminoglycoside antibiotics are used to treat bacterial infections. But these antibiotics may be ototoxic, meaning they may be toxic to the inner ear or to the vestibulo-cochlear nerve — the nerve sending hearing and balance information from the inner ear to the brain.
Currently, there are no FDA-approved treatments to protect hearing in people using aminoglycosides. Besides treating infections in cystic fibrosis patients, aminoglycosides given those with complex urinary tract infections, endocarditis, sepsis, multiple drug-resistant tuberculosis, as well as to premature newborns.
“By reducing or eliminating the debilitating side effect of permanent hearing loss, Oricula sees expanded worldwide use of these inexpensive, highly effective antibiotics for treating life‐threatening bacterial infections,” Malcolm Gleser, MD, CEO of Oricula, said in a press release.
ORC-13661 is designed to protect the sound‐sensing hair cells in the inner ear, which are key for hearing. In previous studies in rats exposed to high doses of aminoglycosides, the treatment prevented much of the hearing loss and hair cell death associated with these antibiotics. They are used to treat gram-negative bacterial infections, including those due to Pseudomonas aeruginosa.
Research on mechanisms causing cell injury and death in the inner ear began in 2001 as a collaboration between Oricula and the University of Washington (UW).
“We are now on the precipice of having an important, life-changing impact on the ability of people to communicate. I am enormously excited about the opportunity to begin clinical trials,” said Edwin Rubel, Oricula’s co-founder and a professor of Hearing Sciences at UW.
Seattle-based Oricula holds an exclusive license to the intellectual property of the research conducted at UW and the Fred Hutchinson Cancer Research Center.
Financial support for ORC-13661’s development came from the National Institute on Deafness and Other Communication Disorders (NIDCD), the Life Sciences Discovery Fund, and the National Institute Of Allergy And Infectious Diseases (NIAID).