ORC-13661 is a new chemical entity discovered and patented (US 9416141 and US 9493482 ) by University of Washington with grant assistance from NIH, and is exclusively licensed to Oricula Therapeutics LLC.
Preclinical testing of ORC-13661 has demonstrated hearing protection in animals treated with high doses of the aminoglycoside antibiotic, amikacin. Importantly, it exhibited no interference of the bactericidal effects of aminoglycosides against pathogenic bacteria. Pharmacokinetic studies revealed high oral bioavailability, linear pharmacokinetics over a wide range of doses, and a half-life which supports once-a-day oral therapy. ORC-13661 completed GLP toxicology studies to support the ongoing clinical program.
An Investigation New Drug (IND) application was approved by the FDA, and a trial of ORC-13661 in normal healthy volunteers was initiated in May of 2018.