To date, 2023 is shaping up to be a relatively brisk year for M&A deals. A recent case in point is Regeneron’s acquisition of Decibel Therapeutics. The centerpiece of the deal is DB-OTO, a gene therapy intended for patients with otoferlin-related hearing loss. The drug is in its first clinical trial. Regeneron agreed to pay $4.00 per share for Decibel stock with the potential to pay up to $3.50 per share in cash if Decibel hits agreed-upon regulatory milestones for DB-OTO in a specified time frame, bringing the total value of the deal to roughly $213 million.

Last year, Decibel touted DB-OTO’s ability to support otoferlin expression for several weeks before it plateaued. The company said the data for the drug were in line with earlier preclinical research in which mice achieved a functional recovery.

Involved in transmission of sound signals in the inner ear, the protein otoferlin is essential for hearing. Deficiency or mutations in the gene that produces otoferlin can cause hearing impairment. Preclinical research reveals the protein is involved in synapse maturation in inner and outer hair cells. 

Back story on the Regeneron acquisition of Decibel Therapeutics

Regeneron has a history of working with Decibel Therapeutics. The companies have worked together on three gene therapy programs, along with the preclinical programs AAV.103 and AAV.104, which target various forms of congenital, monogenic hearing loss.

Relatively few companies have specialized in drug development for hearing and balance disorders. Two such companies, Frequency Therapeutics and Otonomy, have struggled recently. In February 2021, Frequency Therapeutics hit a stock valuation of just over $55 per share. It was recently trading at $0.68. The company is also a lawsuit magnet. As for Otonomy, in late 2022, it said it planned to dissolve its business and liquidate its assets after its drug Otividex missed its primary endpoint in Ménière’s disease. 

While companies like Frequency Therapeutics and Otonomy have faced clinical trial setbacks in hearing loss, broader interest in neuro-otology and medical devices for ear disorders remains strong. Regeneron’s acquisition of Decibel Therapeutics brings additional resources to the therapeutic area.