Some more information about the upcoming presentation and study, Phase 1/2 Hearing Loss Trial of Intratympanic FX322, a Progenitor Cell Activator, has been posted on the AAO-HNSF 2019 conference website.
This information was previously embargoed (fully), but this abstract/preview has just been made public:
Background: Study Objectives: Although most species can regenerate hair cells, hair cell loss in mammals is permanent because the subset of supporting cells that serve as hair cell progenitors during development fail to divide and differentiate on their own. This work showed that two small molecules that now comprise FX322 restore the regenerative potential of mouse and human progenitor cells in vitro and regenerate hair cells when applied to ototoxin damaged mouse tissue. Importantly, a single intratympanic injection of FX322 restores hair cells and auditory function in mice with trauma within one month after treatment. Utilizing small molecules to regenerate hair cells could provide a therapeutic advantage over the complexities and challenges associated with gene and cell therapies. This preclinical body of data supported the start of the first clinical trial of FX322 in patients with sensorineural hearing loss. Methods: The trial was conducted at three private US otolaryngology practices to assess the systemic safety, plasma PK, and effects on otoscopy, audiometry, and word testing of locally-delivered FX322. The trial was double-blinded, placebo-controlled and enrolled 23 patients with medical histories consistent with either noise-induced hearing loss or sudden sensorineural hearing loss which was considered stable (no change ≥10dB at any frequency, ≥6 months, PTA ≤70dB). Patients were randomized to either placebo or FX322 at two different dose volumes, and treatment was given as a single intratympanic dose. Patients were monitored overnight for safety and PK, and returned at months 0.5, 1, 2 and 3 for otoscopy, audiometry and word testing. Results: As of the date of this writing the study remains blinded and final results will be presented at the annual AAO-HNS meeting.
Expect more information on the day of the presentation: September 17, 2019.
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