Astellas and Frequency Therapeutics Reach License Agreement for FX-322

aging vision hearing loss
July 17, 2019

TOKYO, JAPAN and WOBURN, MASSACHUSETTS — Astellas Pharma and Frequency Therapeutics today announced that they have entered into an exclusive license agreement to develop and commercialize Frequency’s regenerative therapeutic candidate, FX-322, for the treatment of sensorineural hearing loss, the most common type of hearing loss. 

Under the terms of the agreement, Astellas will be responsible for the development and commercialization of FX-322 outside of the U.S. and Frequency will be responsible for U.S. development and commercialization.

The companies will be jointly responsible for conducting global clinical studies and coordinating commercial launch activities. Frequency will receive an upfront payment of $80 million and may also receive up to an additional $545 million based on development and commercial milestones, as well as royalties on any future product sales in the licensed territory.


Promising Results for Hearing Restoration Candidate, FX-322


Frequency recently completed a Phase 1/2 clinical study in the U.S. in which FX-322 was observed to be well-tolerated following a single intratympanic injection, with no serious adverse events. Improvements in hearing function were observed in multiple FX-322 treated patients. Frequency plans to initiate a Phase 2a study in the fourth quarter of 2019.

FX-322 is a proprietary combination of small-molecule drugs designed to restore hearing function by activating inner ear progenitor cells already present in the body to induce hair cell regeneration. Sensorineural hearing loss is the result of damage to and/or loss of sensory hair cells in the inner ear. These inner ear hair cells do not spontaneously regenerate once damaged, although progenitor cells capable of regenerating hair cells remain present in the ear in an inactive state.

“FX-322 is a program that focuses on the mechanism of regeneration. Astellas is committed to exploring all types of partnership opportunities to turn cutting-edge science and technological advances into value for patients,” said Naoki Okamura, Representative Director Corporate Executive Vice President, Chief Strategy Officer, Astellas. “We look forward to further investigating the potential of FX-322 to improve hearing function in patients around the world.”

“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. 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.”

–David Lucchino, CEO of Frequency Therapeutics

Astellas reflected the impact from this agreement in its financial forecasts of the current fiscal year ending March 31, 2020.


About Astellas
Astellas Pharma Inc., based in Tokyo, Japan, is a company dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceutical products. For more information, please visit our website at

About Frequency Therapeutics
Frequency Therapeutics is a biotech company focused on developing small molecule drugs that stimulate cells in the body to reverse biological deficits and restore healthy tissue. Through the transitory activation of these cells, Frequency aims to develop therapies that can enable disease modification without the complexity of genetic engineering. Our development candidates use 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 platform may have the potential to touch upon a wide breadth of therapeutic areas. For more information visit


Source: Frequency Therapeutics

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