oricula clinical trial hearing loss drug

Oricula Therapeutics Gets FDA Clearance for Clinical Trials with Investigational New Drug

SEATTLE, WASHINGTON — Oricula Therapeutics, a biotech startup firm based in Seattle, announced today that it has received FDA clearance to begin volunteer human testing for safety, tolerability, and pharmacokinetics of their investigational drug ORC-13661.  In animal studies, ORC-13661 was found to provide highly significant protection of hearing in rats exposed to high doses of aminoglycoside antibiotics–a class of drugs known to cause hearing loss.

The investigational compound works by protecting the sound‐sensing hair cells in the inner ear from damage. If the clinical trials are successful, ORC-13661 could become the first FDA-approved medicine to prevent hearing loss for patients undergoing aminoglycoside treatment.


“Patients with cystic fibrosis, immune suppression, endocarditis, non-TB Mycobacteria, multiple drug-resistant TB as well as premature newborn infants are all candidate for aminoglycoside treatment and could benefit. By reducing or eliminating the debilitating side effect of permanent hearing loss, Oricula sees expanded worldwide use of these inexpensive, highly effective antibiotics for treating life‐threatening bacterial infections.”

Malcolm Gleser, MD, PhD, Oricula Therapeutics CEO 


According to Edwin Rubel, Oricula co-founder and University of Washington Chaired Professor of Hearing Sciences said, “This research began in 2001 as a collaboration with Oricula co-founder David Raible, Professor of Biological Structure at the UW School of Medicine, to advance our understanding of the injury and death of receptor cells in the inner ear. Since these modest beginnings, we established a great, diverse team to accelerate development. We are now on the precipice of having an important, life-changing impact on the ability of people to communicate.  I am enormously excited about the opportunity to begin clinical trials.”

Oricula is commercializing 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. Funding for the preclinical development was obtained through grants from the National Institutes of Health, including a $2.1 million grant from National Institute Of Allergy And Infectious Diseases. 


Source: Oricula Therapuetics; featured image courtesy medlineplus