On July 17, Astellas Pharma announced that it had entered into an agreement with Frequency Therapeutics to co-develop and commercialise FX-322, a regenerative therapy to treat hearing loss.

Astellas Pharma will be responsible for the development and commercialisation of the therapy outside of the US, while Frequency Therapeutics will be responsible for development and commercialisation within the US. Both companies will be involved in conducting global clinical trials. Frequency Therapeutics is to receive $80m, followed by up to $545m in future milestone payments as well as royalties on sales outside the US

Sensorineural hearing loss, the most common form of hearing loss, occurs when inner ear hair cells become lost or damaged. Although these hair cells do not naturally regenerate, dormant inner ear progenitor cells capable of regenerating hair cells remain.

FX-322 is a drug consisting of a combination of small molecules that target these dormant inner ear progenitor cells, spurring the regenerative replacement of lost and damaged hair cells in order to restore hearing. Currently, there are no treatments for sensorineural hearing loss.

Astellas Pharma’s move comes after positive tolerance results were reported for Frequency Therapeutics’ completed Phase I/II clinical trial in the US. The World Health Organization estimates that there are about 466 million people who suffer from disabling hearing loss globally, with over 1.1 billion young people aged 12–35 years at risk of hearing loss due to recreational noise exposure.

This move by Astellas Pharma and Frequency Therapeutics demonstrates confidence in FX-322 as a global therapeutic for hearing loss, and is a prime example of the capacity of novel regenerative therapies to change the healthcare landscape and open new market opportunities for companies that are willing to develop these treatments.

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