The deal is structured to provide Frequency Therapeutics, a Massachusetts, US-based biotech, with an $80m (€71m) upfront fee, with a potential $545m to follow dependent on development and commercial milestones, as well as royalties on sales.
Astellas, a Japanese pharma company, will gain ex-US rights to FX-322, which is a potential treatment for sensorineural hearing loss – the most common type of hearing loss. At present, there are no approved treatments for the condition.
The two companies will divide the development and commercialization costs based on region, which sees Astellas responsible for these costs outside of the US and Frequency within the US.
Frequency initiated a Phase I/II trial in August 2018, before it published positive data that found the treatment was safe and well-tolerated, and ‘multiple’ patients noted an improvement in hearing function.
As a result, Astellas decided to license the drug before it enters a Phase IIa study in the fourth quarter of 2019.
The treatment at the heart of the deal is a small molecule drug that utilizes progenitor cell activation to repair damaged tissue.
Progenitor cells already exist in the body and the drug candidate ‘awakens’ the cells to potentially be harnessed for the treatment of hearing loss, demyelinating diseases, skin disorders and gastrointestinal conditions.