Hearing loss affects millions of Americans but to date, there are no FDA-approved medicines to treat them. Frequency Therapeutics is developing a hearing loss drug that taps into the body’s regenerative capabilities. As the company prepares to advance the experimental treatment to mid-stage studies, it is planning an IPO to finance the research.
Frequency set a preliminary $100 million IPO target, according to paperwork filed with securities regulators on Friday. The Woburn, MA, company has applied for a Nasdaq listing under the stock symbol “FREQ.”
The process of hearing involves tiny hair cells that turn vibrations into electric signals picked up by the auditory nerve. People can lose these hairs (pictured above) due to age, exposure to loud noise, infections, or as a side effect of medication. These lost hairs don’t grow back. Frequency’s lead drug, FX-322, is intended to coax dormant cells in the inner ear into growing new hair cells.
Frequency’s path to a hearing loss drug began in the gut. The intestine is one of the most regenerative organs in the body, replacing and repairing itself constantly. Frequency says in the filing that MIT’s Robert Langer and Jeffrey Karp at Harvard Medical School discovered that this intestinal regeneration happens by constant activation of progenitor cells, a type of cell that can differentiate into many types of cells. Their research also found that this cell activation could be replicated with small molecules.
Progenitor cells are present, but inactive, throughout the body. Frequency says FX-322 is a combination of small molecules that activates progenitor cells in the inner ear. The drug is administered by needle through the eardrum in a 10 to 15 minute procedure similar to one that ear, nose, and throat specialists routinely perform in their offices, the company says. The Frequency drug is liquid at room temperature, but at body temperature it becomes a gel, which the allows the active ingredients of the compound to diffuse throughout the inner ear. Frequency notes that this type of drug formulation has been used in other FDA-approved ear products.
In a Phase 1/2 study enrolling 23 patients, Frequency reported a statistically significant improvement in word recognition, a measure of hearing function. The drug was also well tolerated by patients. Frequency plans to start a Phase 2a clinical trial in the fourth quarter. The study, which will enroll approximately 96 patients, is expected to report preliminary data in the second half of next year.
The FX-322 research has led to one deal so far. In July, the company reached an agreement with Tokyo-based Astellas Pharmaceuticals, which paid $80 million up front for the Japanese rights to develop and commercialize the company’s hearing loss drug. Frequency could earn up to $545 million more depending on the drug’s progress, plus royalties from sales if it reaches the Japanese market.
Other companies are also developing hearing loss drugs. Boston-based Akouos is developing a gene therapy to treat inherited forms of hearing loss. Another Boston firm, Decibel Therapeutics, is developing small molecule drugs and gene therapies for hearing loss.
Frequency says it will use the IPO cash to complete the Phase 2a test of FX-322. The company will also continue development of other compounds in its platform, including an experimental multiple sclerosis drug that is being prepared for human testing.The MS drug is based on research licensed from the California Institute for Biomedical Research and The Scripps Research Institute, which is also a research partner, according to the filing. Besides MS, Frequency says its progenitor cell activation technology has potential applications in diseases affecting muscles, the gastrointestinal tract, skin, and bones.
Since its founding in 2014, Frequency has raised about $228 million, according to the filing. The company’s most recent financing was a $62 million Series C round in July. Frequency’s largest shareholder is Perceptive Life Science Master Fund with a 7.8 percent stake, followed by Taiwania Capital Management’s 5.7 percent stake.
Here’s more on Frequency’s origins.
Image by Frequency Therapeutics