Grant Supports Steps Towards Investigational New Drug Filing and Clinical Trials
SEATTLE, April 30, 2014 /PRNewswire/ — Oricula Therapeutics, LLC, a biotech company uniquely positioned to introduce medicines to preserve hearing, announced that it has received a grant of $169,398 through the Small Business Innovation Research Program by the National Institute on Deafness and Other Communication Disorders of the National Institutes of Health. The award supports preclinical studies to confirm that Oricula's new chemical entities are both safe and effective for hearing protection. When complete, the results will form the basis for an FDA Investigational New Drug (IND) application to allow phase-one clinical trials to proceed. If successful, Oricula's product will be the first medicine to be FDA-approved to protect the inner ear from the damaging effects of antibiotics that are known to cause permanent hearing loss.
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Oricula Therapeutics secured the grant to continue current research in therapeutics that effectively protect the hair cells in the inner ear from damage or death caused by certain antibiotics, specifically aminoglycosides (AGs). The funded research has two primary objectives: 1) Using different strains of bacteria, confirm that the chemical entities do not interfere with the bactericidal effectiveness of the antibiotics and do not cause bacteria to mutate; and 2) Evaluate the safety and tolerability of the lead entity in mammals at specific dosage levels. According to Oricula CEO Malcolm Gleser, MD, PhD, "This is an exciting next step. During this phase, we'll complete preliminary dose range-finding toxicology in the lead chemical entity, which positions us to start our GLP program towards IND filing and, ultimately, clinical trials."
Oricula Therapeutics has focused its research on protecting hearing from damage caused by AGs, an important and greatly underused class of antibiotics. Despite the known side effect of potential hearing damage, aminoglycosides are important for the treatment of a variety of serious infectious diseases including septicemia, multiple drug resistant TB, and pseudomonas infection in patients with cystic fibrosis. However, because as many as 20 percent of patients treated with AGs develop measurable, irreversible hearing loss or even deafness, AGs – an inexpensive and effective antibiotic – have become a treatment of last resort. A medicine to effectively protect hearing, reducing or eliminating this safety concern, would open the door to broader worldwide use of this highly effective class of antibiotics.
About Oricula Therapeutics
Privately held Oricula Therapeutics, LLC, headquartered in Seattle, Wash., is one of the first biotech companies focused on introducing medications to preserve hearing and balance from the damaging effects of medications and aging. Founded in 2013, Oricula is commercializing research conducted at the University of Washington and it holds exclusive license to the resulting intellectual property. This uniquely positions Oricula to introduce the first medication to be FDA-approved to prevent hearing loss for patients undergoing aminoglycoside antibiotic treatment by protecting the sound-sensing hair cells in the inner ear that are necessary for hearing. By reducing or eliminating the debilitating side effect of permanent hearing loss, Oricula hopes to open the door to wider worldwide use of inexpensive, effective antibiotics in the treatment of life-threatening bacterial infections. Oricula's first product is in pre-clinical development, progressing toward FDA Initial New Drug (IND) filing. For more information, visit oricularx.com.
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