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Preserving hearing is our mission

Oricula Therapeutics, LLC, is working to develop the first medication to be approved to prevent drug-induced hearing loss. Our first product ORC-13661, will prevent the hearing loss that is a frequent side effect of the administration of the aminoglycosides, an important class of antibiotics,. Reducing or eliminating this hearing loss would allow broader and more effective worldwide use of these important antibiotics for the treatment of life-threatening bacterial infections, such as pneumonia, endocarditis, neonatal septicemia and multi-drug resistant tuberculosis. The FDA has allowed our Investigational New Drug (IND) filing for this product to move forward to early human testing.


 
 

Hearing and as balance are dependent upon tiny hair cells in the inner ear. Humans are born with approximately 15,000 of these hair cells. They don't regenerate, so once they are lost due to damage or aging, hearing and balance are affected. Our mission is to develop medicines that preserve hearing and balance by protecting these inner ear hair cells from the damaging effects of drugs and aging.

 

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We use Zebrafish

Counting hair cells

Work by us and our colleagues worldwide has shown that zebrafish hair cells have many properties in common with the inner ear hair cells of humans and other mammals.

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Medicines to Preserve Hearing

Developing Products

Oricula Therapeutics' first oral product (ORC-13661), a medicine to preserve hearing during aminoglycoside therapy, has successfully completed Phase 1 human testing for safety, tolerability and pharmacokinetics. The pharmacokinetics were favorable with linear dose proportionality and a long half-life (> 72 hours) enabling once daily oral dosing.  ORC-13661 was well tolerated and, at doses greater than threefold above the expected clinical dose, there were no drug or dose related adverse events.  A Phase 2 proof of efficacy clinical trial is planned.