BOSTON & SEATTLE — Boston-based biotech firm, Decibel Therapeutics, announced this week that it has obtained “an exclusive, worldwide license to the development and commercialization of ORC-13661” from Oricula Therapeutics for the prevention of hearing loss and balance disorders due to the use of aminoglycoside antibiotics.
As part of the agreement with Decibel, Oricula will provide ongoing scientific advice and support.
“Aminoglycosides are an important class of antibiotics that offer powerful efficacy for serious infections. With that efficacy, however, comes the risk of permanent hearing loss and balance problems, which can have a significant impact on quality of life. This is especially true for cystic fibrosis patients, who often require repeat courses of aminoglycosides to treat pulmonary exacerbations throughout their life. We are thrilled to partner with Decibel to bring this much-needed medication to clinicians and patients.” –Malcolm Gleser, M.D., Ph.D, Oricula CEO
With origins in a research collaboration between the University of Washington and the Fred Hutchinson Cancer Research Center, ORC-13661 was licensed to Oricula Therapeutics in 2013 to accelerate preclinical research activities and advance the compound into the clinic. A Phase I clinical trial to evaluate safety, tolerability and pharmacokinetics is currently ongoing.
Development of the new drug offers hope to reduce the ototoxic risks posed to populations more likely to require the use of aminoglycoside antibiotics, such as those being treated for pulmonary exacerbations associated with cystic fibrosis, non-tuberculous mycobacterial infections, multidrug-resistant tuberculosis, and endocarditis.
According to Paula Cobb, EVP of Corporate Development at Decibel, “We are eager to apply our expertise and resources to the development of a novel medicine addressing a significant unmet need. Clinicians and patients should not have to sacrifice hearing and balance to achieve the potent antibiotic efficacy of aminoglycosides.”
ORC-13361 is a new chemical entity (NCE) currently being investigated for the prevention of ototoxicity which results from treatment with aminoglycoside antibiotics. It is thought to work by temporarily blocking aminoglycosides from entering into hair cells in the inner ear, thereby preventing damage before it can occur. Two relevant composition of matter patents, valid through 2036, have been granted by the USPTO and related global filings are in process. ORC-13661 is also referred to as DB-041.