A new hope for patients facing irreversible ototoxicity resulting from the use of an important class of antibiotics

Boston, Mass. and Seattle, WA, September 27, 2018 – Decibel Therapeutics and Oricula Therapeutics today announced that Decibel has obtained an exclusive, worldwide license to the development and commercialization of ORC-13661, an oral medication developed by Oricula Therapeutics for the prevention of hearing loss and balance disorders that can occur following treatment of severe infections with aminoglycoside antibiotics. Particularly susceptible populations include those treated for pulmonary exacerbations associated with cystic fibrosis, non- tuberculous mycobacterial infections, multidrug-resistant tuberculosis, and endocarditis. As part of the agreement, Oricula will provide ongoing scientific advice and support.

“Aminoglycosides are an important class of antibiotics that offer powerful efficacy for serious infections,” said Oricula CEO Malcolm Gleser, M.D., Ph.D. “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.”

With roots 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.

“Decibel has built the first fully integrated discovery, development, and translational platform tailor-made for hearing therapeutics. Our specialized capabilities in hearing have increasingly led world-class hearing researchers like the team at Oricula to seek out partnerships with Decibel,” noted Paula Cobb, EVP 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.”

About ORC-13661

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.

About Decibel Therapeutics, Inc.

Decibel Therapeutics has established the world’s first comprehensive drug discovery, development, and translational research platform to discover and develop therapeutics to protect, repair, and restore hearing. To serve the over half a billion people globally living with hearing loss and related disorders, Decibel is committed to creating a world in which the benefits and joys of hearing are available to all. Decibel is headquartered in Boston, Mass.

For more information about Decibel Therapeutics, please visit www.decibeltx.com or follow @DecibelTx on Twitter.

About Oricula Therapeutics

Founded in 2013, privately held Oricula Therapeutics, LLC, headquartered in Seattle, Wash., is one of the first biotech companies introducing medications to preserve hearing and balance from the damaging effects of medications and aging. Prior to this agreement, Oricula has been commercializing the research conducted at the University of Washington and the Fred Hutchinson Cancer Research Center and holds an exclusive license to the resulting intellectual property. ORC-13661 is the first medication developed by Oricula for the prevention of hearing loss and balance disorders that can occur following treatment of severe infections with aminoglycoside antibiotics. This medication has received FDA Initial New Drug (IND) approval to proceed with human trials. For more information, about Oricula Therapeutics, please visit www.OriculaRx.com.

Media Contacts

Oricula Media Contact:
Cheryl Isen
Isen and Company

Decibel Media Contact:
Sara Green
Ten Bridge Communications