Astellas Pharma (OTCPK:ALPMF) inks an agreement with Woburn, MA-based Frequency Therapeutics to co-develop and commercialize a regenerative therapeutic candidate, FX-322, for the treatment of sensorineural hearing loss.
Frequency will be responsible for development and commercialization in the U.S. while Astellas will have the same responsibilities ex-U.S. They will jointly conduct global clinical trials and will coordinate commercial launch activities.
Under the terms of the deal, Astellas will pay Frequency $80M upfront, up to $545M in milestones and royalties on net ex-U.S. sales.
A Phase 2a study should launch in Q4.
FX-322 is a proprietary combination of small molecule drugs designed to restore hearing function by activating inner ear progenitor cells already present in the body to induce hair cell regeneration. Sensorineural hearing loss is the result of damage to and/or loss of sensory hair cells in the inner ear. These inner ear hair cells do not spontaneously regenerate once damaged, although progenitor cells capable of regenerating hair cells remain present in the ear in an inactive state.
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