cochlea

Hearing Restoration Study Enters Phase 2

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We first blogged about the first in-human safety study aimed at restoring hearing last January. It was one of our most read blog posts of the year. With that level of interest, we wanted to share the most recent news on this study.

The loss of inner ear hair cells is the most common cause of sensorineural hearing loss. Once these cells are damaged, they cannot grow back. This causes permanent hearing loss. Frequency Therapeutics, a U.S.-based biotechnology company, has created FX-322, a Progenitor Cell Activation (PCA™) regenerative medicine aimed at creating new inner ear hair cells in the cochlea. With the successful completion of its first in-human safety study a year ago, the company received an additional $42 million in financing to allow the research to advance to Phase 2. The company stated that top-line results from an on-going Phase 1-2 study are expected in the first half of this year. Frequency Therapeutics has received a total of $87 million.

You can read the full press release here. We will be following this study and will share updates to the research findings as news is released.

Research Watch: First-In-Human Safety Study for Hearing Restoration

Image credit: University of Virginia Health System

Image credit: University of Virginia Health System

The loss of inner ear hair cells is the most common cause of sensorineural hearing loss. Once damaged (due to loud noises, trauma, aging and other factors), these hair cells cannot grow back, which causes permanent hearing loss. U.S.-based biotech company Frequency Therapeutics is trying to change that. Last month, the company successfully completed the first-in-human study of FX-322, a Progenitor Cell Activation (PCA™) regenerative medicine aimed at creating new inner ear hair cells in the cochlea.

FX-322 previously worked at restoring hearing in animals. This first-in-human study was to prove the safety and tolerability of it. Nine adults with severe to profound sensorineural hearing loss who were scheduled to receive a cochlear implant in the 24 hours following receiving FX-322 were enrolled in the study. The success of this trial means that future trials may take place in patients with moderate hearing loss who are not candidates for the cochlear implant and whose hearing can be studied over time. 

You can read more about this study here. We're unsure of the timeframe - it could be years - but we're encouraged for our patients about the research taking place.