SEATTLE, WASHINGTON — Oricula Therapeutics, LLC, a biotech startup firm based in Seattle, announced today that it has received a Phase 2 Grant of approximately $2 million dollars from the Small Business Innovation Research (SBIR) program through the National Institute of Allergy and Infectious Diseases of the National Institutes of Health (NIH).
The award funds will support the completion of the company’s pre-clinical workup for a new compound (ORC-13661) designed to protect the inner ear from permanent hearing loss caused by aminoglycoside antibiotics. The funds will also help support an FDA Investigational New Drug (IND) application for future clinical trials.
If successful, the new drug could potentially allow a wider use of aminoglycosides to combat serious infections, without concerns over potential toxicity to the auditory system.
Initial Results Show Promise
Prior to securing the latest grant from the NIH, the company reports that animal model tests using the compound (ORC-13661) provided 100 percent hearing protection for rats co-administered a 10-day course of the aminoglycoside, amikacin.
According to the company, histological examination of the cochlear epithelium from animals in the study found no evidence of hair cell death. ORC-13661 is reportedly not mutagenic and does not interfere with the in vitro bactericidal potency of aminoglycosides against bacterial strains such as E.coli, P. aeruginosa, and M.tuberculosis.
“Now that the preclinical workup is assured, I’m spending much of my time designing the ideal first-in-human proof-of-concept clinical trials for our lead compound.” —Malcolm Gleser, MD, PhD, Oricula CEO
While it can be an effective tool against serious bacterial infections, aminoglycosides may cause permanent hearing loss in nearly a quarter of individuals receiving treatment. If proven successful, the new drug would be the first medicine to receive FDA-approval to protect the inner ear from permanent hearing loss caused by aminoglycoside antibiotics.