Decibel Therapeutics has forged an unusual alliance with Regeneron that gives it access to the big biotech’s scientific expertise—without giving away rights to its drug candidates for hearing loss and tinnitus.
It will get research funding and “significant” R&D support from Regeneron (PDF), and scientists from the two companies will work shoulder-to-shoulder on the programs, according to Decibel’s CEO Steve Holtzman, a Biogen veteran who took the top job at the company last year. But in a twist to the usual model, Decibel “retains exclusive, worldwide commercialization rights for all hearing drug candidates discovered in the collaboration,” he tells us.
Regeneron has taken a “significant but not dominant equity position in Decibel” and will contribute technology to optimize full-human antibodies as well as provide access to data from its gene sequencing operations, says Holtzman. As well as R&D funding, it has also pledged milestone payments for development successes, and in return will claim royalties on any products that make it through to market.
The level of collaboration envisaged by the new alliance is “often touted, but rarely put into practice,” says Holtzman, and will see the two partners working on an initial group of drug targets—still in the preclinical development phase—that are involved in “several hearing loss conditions including forms of genetic hearing loss, hearing loss consequent to exposure to ototoxic drugs, and hearing loss and tinnitus resulting from noise exposure.”
Decibel has already garnered attention for its “end-to-end” approach to hearing problems, spanning hearing biology, drug delivery to the inner ear and translational medicine approaches in hearing, gathering technologies to separate patients according to the underlying pathophysiology of their hearing loss, and to measure changes in hearing with improved audiological assessment methods.
The ultimate aim of the new partnership is to take multiple therapeutics forward that could become effective drugs for what the World Health Organization estimates is around 360 million people worldwide—5% of the world’s population—who suffer from disabling hearing loss.
“To date, hearing loss has been exclusively addressed through the use of devices, hearing aids and cochlear implants. There aren’t any approved therapeutics for hearing loss or tinnitus,” says Holtzman.
And while there are a handful of companies working to address that deficiency, “most are founded around a single asset or two assets, mainly repurposed from other therapeutic areas, and aren’t capitalized to make the kinds of investments that Decibel and now Regeneron are able to bring in putting together the science-based understanding of hearing biology.”
“We’re building the tools and team at Decibel to lead the field.”
Several big pharma firms have active programs in hearing loss—Pfizer, Roche, Sanofi, Novartis, Boehringer Ingelheim and GlaxoSmithKline, for example—as well as an array of smaller drug developers including Auris Medical, which has just seen a sudden deafness candidate fail a phase 3 trial, and Frequency Therapeutics.