About two to three out of every 1,000 children in the US are born with a detectable level of hearing loss, according to the National Institute on Deafness and Other Communication Disorders (NIDCD) division of the NIH. About 15% of adults report some trouble hearing, and men are almost twice as likely as women to have hearing loss. Over 500 million people globally live with hearing loss and related disorders, and this number continues to grow.

Decibel Therapeutics, which was launched in 2015 with a Series A financing led by Third Rock Ventures, announced today that it had raised $55 million in a Series C round. All existing investors, including Third Rock, GV, SR One and Regeneron Pharmaceuticals REGN participated in the round, and were joined by new investors including Foresite Capital, Bessemer Trust, Schroder Adveq, SCubed Capital, Longevity and additional undisclosed institutional investors.

Decibel has identified acute, targeted indications that that can provide near-term opportunities for human proof-of-concept for the company’s therapeutic candidates. Frank Vinluan writes in Xconomy that Decibel should have two compounds in clinical trials by this time next year, according to Mr. Holtzman. A third gene therapy treatment is expected to enter clinical studies within two years. “The most advanced Decibel compounds were developed to protect against hearing loss caused by other drugs,” writes Mr. Vinlaun. “Hearing loss is a side effect of as many as 600 drugs, including painkillers such as aspirin and non-steroidal anti-inflammatory drugs, Holtzman says. It’s also a side effect of cisplatin, a chemotherapy that is a first-line treatment for a number of cancers.”

Decibel and Regeneron have been collaborating since November 2017 in a deal that, according to Kevin Starr, co-founder and partner at Third Rock, “stands out as one of the most unique collaborations that I have seen in my 30-plus years in biotech.” Regeneron provides Decibel with broad access to its proprietary suite of technologies to support Decibel’s drug discovery, and directly participates in and provides financial support for Decibel’s research and development efforts, both through funding payments and a strategic equity investment. Decibel retains worldwide development and commercialization rights to any products discovered in the collaboration and will pay Regeneron tiered royalties based on net sales.

Recent scientific advances, including those by Decibel’s founders, have provided insights into the link between hearing dysfunction and inner ear pathology. These discoveries have defined potential new therapeutic targets for the treatment of multiple types of hearing disorders. These insights have shown that the synapse in the ear is the most vulnerable component of the hearing circuit, and this synaptopathy is the underlying pathology linked to many major hearing disorders.

Published data by Decibel’s founders suggest that by restoring the synapse, the inner ear hearing circuit can be preserved, and hearing can be restored and maintained. Emerging data also suggest that synaptopathy is likely more prevalent than currently estimated by traditional audiometric measurements. This “hidden hearing loss” could represent a major source of sound fidelity and speech recognition deficits across multiple populations, and may precede a progressive decline in hearing.

President and CEO Steven Holtzman joined Decibel in 2016. He previously served as EVP, corporate development at Biogen, where he created and led the program leadership and management group through eight new drug approvals. He also led the business development and M&A group through successful completion of numerous transactions. Prior to Biogen, Mr. Holtzman was founder, CEO and Chairman of Infinity Pharmaceuticals, chief business officer of Millennium Pharmaceuticals (now Takeda Oncology) and a founder, board member and EVP of DNX Corporation.

Decibel was founded by experts in inner ear biology and hearing disorders who collectively bring expertise across numerous hearing-related disciplines including hearing physiology and biology, neurotrophins, hearing-related drug delivery, genetics, cochlear implants and regeneration:

  • M. Charles Liberman, PhD, Schuknecht Professor of Otology and Laryngology at Harvard Medical School and Director of the Eaton-Peabody Laboratories at Massachusetts Eye and Ear
  • Gabriel Corfas, PhD, Director of the Kresge Hearing Research Institute, University of Michigan
  • Ulrich Müller, PhD, Bloomberg Distinguished Professor at Johns Hopkins University
  • Albert Edge, PhD, Professor of Otology and Larynology, Harvard Medical School, and Director, Tillotson Cell Biology Unit, Massachusetts Eye and Ear.

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