Biotech company Oricula Therapeutics LLC stated on Monday that it will begin the volunteer human testing for safety, tolerability and pharmacokinetics of their novel, new medicine, ORC-13661, upon the US FDA permission.
Under the company's animal studies, ORC-13661 provided highly significant protection of hearing in rats exposed to high doses of aminoglycoside antibiotics, a common cause of human hearing loss.
Following the company's successful clinical trials, ORC-13661 may be the first US FDA-approved medicine to prevent hearing loss for patients undergoing aminoglycoside treatment.
In conjunction, the company is commercialising research conducted at the University of Washington and the Fred Hutchinson Cancer Research Center and holds an exclusive license to two extensive composition of matter patents.
The funding for the company's preclinical development was obtained through grants from the National Institutes of Health, including a USD2.1m grant from National Institute Of Allergy And Infectious Diseases.
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