Current status

ORC-13661 is a new chemical entity discovered and patented by University of Washington with grant assistance from NIH, and is exclusively licensed to Oricula Therapeutics LLC for all regions. 

Preclinical testing of ORC-13661 has demonstrated oral hearing protection both functionally and histologically in rats treated with high doses of the aminoglycoside antibiotic, amikacin. Importantly, ORC-13661 exhibited no interference with the bactericidal effects of aminoglycosides against pathogenic bacteria. 

ORC-13661 has successfully completed Phase 1 testing in normal human volunteers for safety, tolerability and pharmacokinetics.  The pharmacokinetics were favorable with linear dose proportionality and a long half-life (> 72 hours) facilitating daily oral dosing.  ORC-13661 was well tolerated and, at doses greater than threefold above the expected clinical dose, there were no definite drug or dose related adverse events.  A Phase 2 proof of efficacy clinical trial is planned.