After its hearing loss treatment proved itself safe in a small phase 1 study, Frequency Therapeutics is calling in reinforcements to help it cross the finish line. The company is licensing the program to Astellas Pharma, which will develop and market the drug outside the U.S., for $80 million upfront.
Frequency is developing the treatment for sensorineural hearing loss, the most common form of hearing loss, caused by damage to the fine hairs in the inner ear that sense and translate sound waves. Once damaged, these cells don’t heal on their own. FX-322 is a cocktail of small-molecule drugs designed to restore hearing by targeting dormant cells in the ear to encourage the growth of new hair cells.
Under the deal, Woburn, Massachusetts-based Frequency will hold onto the U.S. rights to FX-322, while Astellas will develop and commercialize it outside the U.S. Both companies will work on global clinical trials for the treatment and coordinate launch efforts, according to a statement.
Frequency is bagging $80 million now, but stands to pick up another $545 million down the line in development and sales milestone payments as well as royalties.
“Collaborating with Astellas provides us an opportunity to work with a partner that has deep, global clinical development and commercial expertise and shares our focus in pursuing novel regenerative medicines for patients with diseases where there are no therapeutic options,” said Frequency CEO David Lucchino in the statement. “We are excited to collaborate with them to advance FX-322 for patients with sensorineural hearing loss and to further demonstrate the potential of our platform for progenitor cell activation.”
The deal comes three months after a phase 1/2 study turned up no serious side effects in patients with stable sensorineural hearing loss. In the study, 23 patients were randomized to receive either a high or low dose of FX-322 or placebo in a single injection through the eardrum. Some of these patients did better on hearing range tests after treatment compared to those on placebo.
“If successful, our lead development program would represent the first time ever that hearing could be restored in humans with a therapeutic,” said Marc Cohen, Frequency’s executive chairman, at the time. “We are defining a new mode of regenerative medicine: activating progenitor cells within your body to repair damaged tissue.”
Frequency raised $42 million in its series B in January to bankroll the development of its other regenerative medicine programs, as well as the clinical testing of FX-322. It plans to start a phase 2a study for FX-322 by the end of the year.