Oricula Therapeutics: investigational new drug approved


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Oricula Therapeutics recently announced United States FDA approval for volunteer human studies of the safety, tolerability, and pharmacokinetics of a novel medicine, ORC-13661 in hearing protection.

Oricula Therapeutics, Llc. is a Washington state-based start-up biotech company founded in 2013 working on medications to preserve hearing and balance. Its candidate compound ORC-13661 was shown in animal studies to provide significant protection of hearing in rats exposed to high doses of aminoglycoside antibiotics. These antibiotics are known to be a common cause of hearing loss in humans.

Malcolm Gleser, MD, Ph.D., who is CEO at Oricula Therapeutics commented on the announcement, telling Markets Insider that “Patients with cystic fibrosis, immune suppression, endocarditis, non-TB mycobacteria, and multiple drug-resistant TB, as well as premature newborn infants are all candidates for aminoglycoside treatment and could benefit.” According to the company, the compound works by protecting the hair cells in the inner ear. One of the main obstacles to the use of this class of inexpensive, highly effective antibiotics is their ototoxicity.

If the studies in humans find the same positive results as in non-clinical studies, ORC-13661 may become the first FDA-approved medicine to prevent hearing loss in patients receiving aminoglycoside antibiotic therapy.

Source: Markets Insider