Astellas Pharma has signed a licensing deal worth up to $625m (£500.66m) with Frequency Therapeutics to develop and commercialise FX-322, the latter’s regenerative therapeutic candidate for the treatment of sensorineural hearing loss.
As per the agreement terms, Astellas will undertake the development and commercialisation of FX-322 outside of the US, while Frequency will be responsible for the development and commercialisation of the regenerative drug candidate in the country.
The two firms will be jointly responsible for carrying out global clinical studies and coordinating activities pertaining to the drug’s commercial launch.
Frequency will be paid $80m (£64.08m) upfront and could also be entitled to an additional payment of up to $545m (£436.57m) based on development and commercial milestones, along with royalties on any product sales in the future in the licensed region.
FX-322 is a combination of small-molecule drugs, which by activating inner ear progenitor cells in the body, induces hair cell regeneration, thereby restore hearing function. Currently, there are no approved therapeutic options available for the treatment of sensorineural hearing loss, which is caused by damage to and/or loss of sensory hair cells in the inner ear.
Astellas representative director corporate executive vice president, chief strategy officer Naoki Okamura said: “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.
“We look forward to further investigating the potential of FX-322 to improve hearing function in patients around the world.”
Recently, Frequency concluded a phase 1/2 clinical study of FX-322 in which the drug was shown to be well-tolerated after a single intratympanic injection, with no serious adverse incidents. Improvements in hearing function were seen in multiple patients treated with the drug.
Frequency plans to begin a phase 2a study in the fourth quarter of this year.
Earlier this year, the US-based clinical-stage biotech company completed a $42m (£33.64m) Series B financing round, which was led by Taiwania Capital Management. The company is focused on developing drugs based on small molecule stimulation of dormant stem cells present within the body for reversing biological deficits and restoring healthy tissue.