Decibel Therapeutics to be Acquired by Regeneron

Pharma giant Regeneron Pharmaceuticals and clinical-stage biotech Decibel Therapeutics have announced a definitive agreement for the acquisition of Decibel by Regeneron. The proposed acquisition values Decibel at a total equity value of approximately $109 million based on the amount payable at closing, and a total equity value of up to approximately $213 million upon achievement of certain clinical development and regulatory milestones for Decibel’s lead investigational candidate, DB-OTO.

Decibel and Regeneron established their initial collaboration in 2017, with an extension announced in 2021, and are developing three gene therapy programs targeting different forms of congenital, monogenic hearing loss. Lead candidate DB-OTO, which is currently in a global Phase 1/2 clinical trial, is an investigational cell-selective, adeno-associated virus (AAV) gene therapy designed to provide durable, physiological hearing to individuals with profound, congenital hearing loss caused by mutations of the otoferlin gene. Preclinical programs include those for GJB2-related hearing loss and stereocilin (STRC)-related hearing loss.

“After full consideration, the Decibel Board has determined that this transaction is the best way to maximize shareholder value and ultimately benefit patients,” said Laurence E. Reid, Ph.D., President and Chief Executive Officer of Decibel. “We have collaborated with our colleagues at Regeneron for the past six years and have huge respect for their research and development capabilities. We have full confidence that with Regeneron’s expertise and resources the Decibel pipeline can be optimally developed, and our team is committed to enabling that long-term success.”

Congenital hearing loss is a significant unmet medical need with no approved medical therapies that affects approximately 1.7 out of every 1,000 children born in the U.S. While hearing loss caused by mutations of the otoferlin gene is rare, the majority of permanent, congenital hearing loss cases diagnosed in developed countries are sensorineural and result from a single gene defect, making them appealing targets for gene therapy. Hearing aids and cochlear implants may offer benefits, but they fall short of replicating normal hearing function. (Source: Decibel Therapeutics Website, 09 August, 2023)