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Frequency Therapeutics Completes Enrollment in Single Dose Safety Trial to Evaluate FX-322, a First-in-Class Drug Candidate for Hearing Restoration


WOBURN, Mass., October 4, 2018 – Frequency Therapeutics, a clinical stage biotechnology company, today announced the completion of enrollment in the single dose safety trial to evaluate FX-322, a first-in-class drug candidate for hearing restoration from the company’s Progenitor Cell Activation (PCA) Regeneration platform. The randomized, double-blind, placebo-controlled trial is assessing the safety of a single dose of FX-322 given by intratympanic administration in adult patients with stable sensorineural hearing loss (SSHL) who have a medical history consistent with either noise exposure or sudden hearing loss.

“We are pleased with how rapidly we were able to recruit patients with stable sensorineural hearing loss, which is a testament to the support from our Clinical Advisory Board, as well as the enthusiasm of our investigators and the participating patient volunteers,” said David Lucchino, President, Co-founder and CEO of Frequency.

The safety trial is a randomized, double-blind, placebo-controlled, single-dose, multi-center study of FX-322, which was administered in patients with stable sensorineural hearing loss and is being conducted at several leading otolaryngology clinics in the United States. Patients received either an injection of FX-322 or a placebo in one ear with an initial follow up visit after two weeks and will continue to be monitored for the following three months.

“The advancement of FX-322 from our first study in cochlear implant patients into patient volunteers with stable sensorineural hearing loss should enable us to open our future studies in the office-based setting,” said Carl LeBel, Ph.D., Chief Development Officer of Frequency. “If successful, the current study will position us to advance to our Phase 2a program where we’ll be looking to identify and characterize a hearing restoration signal and proof of biological concept in sensorineural hearing loss.”

Information on the Phase 1/2 clinical trial can be found at with the identification number: NCT03616223.

Virtually all hearing deficits in humans arise from damage and/or loss of key cells in the inner ear called sensory hair cells. These inner ear hair cells convert sound waves into nerve impulses. In adult mammals, unlike birds or reptiles, inner ear hair cells do not spontaneously regenerate following injury, although progenitor cells capable of regenerating hair cells remain present in the ear. There is no approved therapeutic option for chronic noise-induced hearing loss. Around 48 million people are affected in the U.S. alone, and the World Health Organization (WHO) estimates that 1.1 billion children and adults ages 12-35 years old are at risk for hearing loss from recreational noise. Hearing loss caused by prolonged exposure to excessive noise is observed in many professional environments, such as heavy construction sites or military training. However, repetitive exposure to everyday loud sounds associated with a busy subway or rail system, emergency vehicle sirens, musical concerts and the excessive use of headphones at high volumes can have a negative impact on hearing. Frequency’s therapeutic candidate for noise-induced hearing loss, FX-322, is a proprietary combination of small-molecules drugs designed to transiently activate inner ear progenitor cells, create new hair cells and improve hearing.

Tissue regeneration with Progenitor Cell Activation, or PCA Regeneration, is a new therapeutic approach to repairing damaged tissue and restoring health function in a less complex and potentially safer manner than traditional cell and gene therapy. The approach, based on discoveries in progenitor cell biology from the labs of Bob Langer, Sc.D., at MIT and Jeff Karp, Ph.D., at Harvard Medical School and Brigham and Women’s Hospital, utilizes small molecules to awaken dormant progenitor cells already in the body and has the opportunity to address numerous degenerative diseases such as hearing loss, demyelinating diseases, skin disorders and gastrointestinal conditions.

Frequency Therapeutics develops small molecule drugs to stimulate cells in the body to reverse biological deficits and restore healthy tissue. Through the transitory activation of these cells, Frequency enables disease modification without the complexity of genetic engineering. Our ground-breaking therapy uses a proprietary combination of small-molecule drugs that induce progenitor cells to multiply and create new cells. While Frequency’s lead program targets hearing restoration, our PCA Regeneration platform has the potential to touch upon a wide breadth of disease indications.

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