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Astellas and Frequency Therapeutics Enter into License Agreement for FX-322, a Regenerative Treatment Candidate for Hearing Loss.

M2 PHARMA-July 18, 2019-Astellas and Frequency Therapeutics Enter into License Agreement for FX-322, a Regenerative Treatment Candidate for Hearing Loss


- Japanese drugmaker Astellas Pharma Inc. (TSX: 4503) and US-based biotech company Frequency Therapeutics, Inc. 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, the company said.

At present, there are no approved therapeutic options for sensorineural hearing loss.

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

The companies will be jointly responsible for conducting global clinical studies and coordinating commercial launch activities.

Frequency will receive an upfront payment of USD 80m and may also receive up to an additional USD 545m based on development and commercial milestones, as well as royalties on any future product sales in the licensed territory.

Frequency recently completed a Phase 1/2 clinical study in the US 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.

The World Health Organization estimates that there are currently more than 800 m adults with hearing loss globally. According to the US National Institutes of Health, approximately 90% of those with hearing loss are affected by sensorineural hearing loss.

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

Sensorineural hearing loss is the most common form of hearing loss, resulting from damage to the hair cells in the inner ear or problems with the nerve pathways that convert sound waves from the inner ear to the brain.

Hair cells are commonly lost due to chronic noise exposure, or as a result of aging, certain viral infections or exposure to ototoxic drugs. The WHO estimates that 1.1bn children and adults ages 12 to 35 years old are at risk for hearing loss from recreational noise exposure.

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Publication:M2 Pharma
Date:Jul 18, 2019
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