Today experts at the Medical College of Wisconsin (MCW) are administering the first dose of a potentially groundbreaking investigational medicine that aims to help those with Sensorineural Hearing Loss (SNHL) regrow sensory hair cells within the cochlea to improve hearing.

“There currently are no medications approved for hearing loss, so this trial focuses on addressing the underlying biological causes of SNHL,” said principal investigator Michael Harris, MD, Assistant Professor of Otolaryngology at MCW. “Loss of hair cells in the inner ear is a cause of hearing loss, and once we lose those cells, they do not grow back on their own. This trial therapy aims to produce new cochlear hair cells.”

MCW is one of approximately 30 sites in the United States participating in a Phase 2b clinical trial sponsored by Frequency Therapeutics. Christina Runge, PhD, CCC-A, and David Friedland, MD, PhD, both Professors of Otolaryngology at MCW, serve on the Frequency Therapeutics Clinical Advisory Board. Dr. Runge is also co-author on a paper describing results from a Phase 1 clinical trial for this therapy, called FX-322, the results of which were published in the peer-reviewed journal Otology & Neurotology.

“We administer the study drug via injection through the ear drum into the middle ear. This procedure is very common for otolaryngologists and is generally well-tolerated with a numbing agent,” said Dr. Friedland. “Once injected the active ingredient moves into the inner ear where the hair cells are located to stimulate new growth.”

Growth of cochlear hair cells can help restore hearing function and improve clarity of speech, which is a unique approach that differs from existing treatments for hearing loss. Current treatments focus on making sounds louder via assistive devices but are limited in only addressing the symptoms of hearing loss and not the underlying biological cause.

“The earlier clinical trial determined that this treatment had a favorable safety profile, but we were also able to see signs of effectiveness with clarity in speech, which is encouraging,” said Dr. Runge. “This is cutting edge technology and treatment brought forth by the expertise at MCW and Frequency Therapeutics and is an important discovery for those with SNHL.”

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