Oricula Therapeutics Product History

Oricula Therapeutics' first product (ORC-13661), an oral medicine to preserve hearing during aminoglycoside therapy, has completed Phase 1 clinical 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.

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.  

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.