Evolution of Oricula
Oricula Therapeutics evolved from converging research into hearing loss and compounds that have potential to prevent it. Results of this research identified compounds that protect inner ear hair cells from ototoxins, specifically aminoglycoside antibiotics. This research and its resulting patents created the foundation for Oricula Therapeutics.
Key company and product milestones:
2003: Novel screening method using zebrafish developed at University of Washington
2008: Research using the aminoglycosides class of antibiotics (AGs) as ototoxins leads to identification of a compound (ORC-0001) that protects hair cells in zebrafish and subsequently protection in rats
2011: NINDS Blueprint Neurotherapeutics Program (NIH BPN) Research Grant awarded; drug discovery and pharmaceutical industry expertise added to team
2012: Method of Use Patent awarded to University of Washington for protectant compound ORC-0001
2012: Structured Activity Relationship (SAR) and ADME research identifies analogs to ORC-0001 that are order-of-magnitude more potent.
2013:Composition of Matter Patent for ORC-0001 analogs applied for by University of Washington
2013: Oricula Therapeutics LLC founded
2013: Patents for Method of Use and Composition of Matter exclusively licensed from University of Washington by Oricula Therapeutics
2013: Washington State Life Sciences Development Fund awards University of Washington grant to fund efficacy testing of BPN analogs; studies in rats demonstrates mammalian efficacy of ORC-13661
2014: Oricula Therapeutics awarded a Phase 1 SBIR by NIH NIDCD to study safety of ORC-13661
2016: Composition of Matter Patent for ORC-0001 analogs awarded to University of Washington
2016: Oricula Therapeutics awarded a Phase 2 SBIR by NIH NIAID to advance ORC-13661 to FDA-IND
2018: FDA allowed ORC-13661 to move into human clinical trials
2018: Phase 1 clinical was completed demonstrating favorable pharmacokinetics 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.