Decibel Obtains Exclusive License for ORC-13661 for Prevention of Antibiotic-related Ototoxicity

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by Diogo Pinto |

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SPI-1005 for ototoxicity

Decibel Therapeutics received worldwide, exclusive rights to develop and commercialize ORC-13661, Oricula Therapeutics’ investigational treatment to prevent hearing loss and balance disorders in patients taking high doses of aminoglycoside antibiotics, including cystic fibrosis (CF) patients.

Under the terms of the agreement, Oricula will provide scientific advice and support to Decibel throughout the ORC-13661 development process.

ORC-13661 was developed to preserve hearing during treatment with aminoglycosides, a class of antibiotics created to kill a specific type of bacteria called gram-negative bacteria. Aminoglycosides are known to potentially cause severe side effects, including ototoxicity, i.e., toxicity to the inner ear or to the vestibulo-cochelar nerve — the nerve sending hearing and balance information from the inner ear to the brain.

Ototoxicity may lead to ear cell death and subsequent hearing loss and balance problems.

Ototoxicity is particularly relevant for CF patients, who are often treated with repeated doses of aminoglycosides for lung exacerbations. Other patient populations also at high risk of ototoxicity are those receiving these antibiotics for the treatment of non-tuberculous mycobacterial infections, multidrug-resistant tuberculosis, and endocarditis.

“Aminoglycosides are an important class of antibiotics that offer powerful efficacy for serious infections,” Malcolm Gleser, MD, PhD, Oricula’s CEO, said in a press release.

“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,” he said.

ORC-13661 is thought to temporarily block aminoglycosides from leaving the bloodstream and entering hair cells in the inner ear, preventing damage.

The therapy was discovered and patented by the University of Washington, in collaboration with the Fred Hutchinson Cancer Research Center, and supported by the National Institutes of Health (NIH).

In 2013, ORC-13661 was licensed to Oricula to accelerate preclinical research and advance the treatment into clinical studies.

Preclinical studies demonstrated the protective effects of ORC-13661 on hearing in animals treated with high doses of amikacin, an aminoglycoside antibiotic. Importantly, the treatment showed no interference on the antibiotic’s killing effect against pathogenic bacteria.

Earlier this year, the U.S. Food and Drug Administration approved Oricula’s investigational new drug application for ORC-13661, and the company started a Phase 1 trial evaluating the therapy’s safety, tolerability, and pharmacokinetics (how the human body processes a drug) in healthy volunteers.

“Decibel has built the first fully integrated discovery, development and translational platform tailor-made for hearing therapeutics. 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,” said Paula Cobb, executive vice president of corporate development at Decibel.