Boehringer Ingelheim has come sweeping down into Oklahoma to land rights to a treatment for the most common type of permanent hearing loss, joining up with Autigen in a $100 million biobucks deal to work on a drug that restores sensory hair cells.
The collaboration and licensing agreement is focused on sensorineural hearing loss (SNHL), a condition caused by inner ear damage that cannot typically be treated using surgery or current medicines. Autigen, a subsidiary of Oklahoma-based Otologic Pharmaceutics, has identified small interfering RNA as a way to regenerate lost hair cells and thereby restore the hearing of people with SNHL.
Boehringer sees promise in the approach. Under the terms of its deal with Autigen, Boehriger will make an upfront payment and provide research funding to access the science. The partners will perform a joint research collaboration, after which Boehringer will take over for further preclinical work and beyond. All told, Boehringer could hand over more than $100 million in milestones to Autigen.
If the deal is to come close to that sum, the approach will need to live up to the promise it has shown in preclinical tests. Otologic struck a deal with Hough Ear Institute for technology to restore sensory hair cells in the inner ear back in 2015. Two years later, Otologic, in collaboration with secured $1.9 million from the Department of Defense to fund development of their candidate, OPI-001.
The funding award revealed the partners planned to use siRNA against the Notch pathway gene, hairy and enhancer of split 1, also known as Hes1, to regenerate hair cells. Researchers at Otologic and Hough have since shown the concept works in animals, presenting data on the regeneration of hair cells and recovery of hearing in guinea pigs back in 2018.
Progress has taken longer than originally planned. Otologic talked about getting into the clinic in 2017 when it licensed the technology from Hough and targeted a 2020 start of human studies when it landed the grant funding. With Boehringer on board, Otologic, through its Autigen subsidiary, now has support for its push to get into the clinic.
Boehringer is trailing the front runners in the SNHL space. Sound Pharmaceuticals has run midphase trials of its anti-inflammatory and neuroprotective drug SPI-1005, leading it to move into a late-phase study in Meniere’s disease, and Eli Lilly-based Audion Therapeutics is preparing to start a phase 2b trial of its gamma secretase inhibitor in SNHL.