Decibel adds first clinical candidate with Oricula license deal

Decibel just transformed itself into a clinical-stage biotech by licensing a phase 1 candidate from Seattle startup Oricula Therapeutics.

Hearing loss specialist Decibel has been advancing its own portfolio of preclinical-stage drugs, teaming up with Regeneron on that effort last year. The Oricula deal gives it a new lead drug—ORC-13661—in early-stage testing for hearing loss and balance disorders that can follow treatment of severe infections with aminoglycoside antibiotics such as amikacin.

Hearing-damaging side effects are a well-recognized risk with aminoglycosides, particularly in patients who need repeated treatment such as those with cystic fibrosis, tuberculosis and other mycobacterial infections, and bacterial infections of the heart lining, says Decibel. The drugs can cause irreversible damage to hair cells in the inner ear, leading to hearing loss, tinnitus, vertigo and dizziness, but are still widely used because for some infections there are few effective alternatives.

ORC-13661 has emerged from research at the University of Washington and the Fred Hutchinson Cancer Research Center, and is thought to work by temporarily blocking aminoglycosides from entering into hair cells in the inner ear, preventing damage before it can occur. The drug was discovered using zebrafish, a species which have external hair-like cells and so are a great model system for screening candidates to treat hearing loss.

"Aminoglycosides are an important class of antibiotics that offer powerful efficacy for serious infections," says Malcolm Gleser, M.D., Ph.D., Oricula’s CEO.

"With that efficacy, however, comes the risk of permanent hearing loss and balance problems, which can have a significant impact on quality of life." Currently, there are no FDA-approved treatments to protect hearing in people using aminoglycosides.

Decibel already has some competition in the frame for the program however, as Sound Pharmaceuticals is also testing its SPI-1005 (ebselen) drug for ear toxicity caused by intravenous tobramycin in patients with CF. That project started phase 1b earlier this year with the help if a $1.8 million grant from Cystic Fibrosis Foundation Therapeutics (CFFT). Ebselen—which is thought to work by preventing oxidative damage to hair cells—is also in phase 2 for hearing loss caused by chemotherapy.

Meanwhile, Frequency Therapeutics is taking a different approach, testing a therapy called FX-322 that is designed to stimulate the production of new hair cells in the inner ear in people whose hearing is already damaged.

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