Allon Therapeutics has received US FDA fast-track status for its drug candidate davunetide as a treatment for progressive supranuclear palsy (PSP), a degenerative brain disease.
Allon announced completion of a phase 1 clinical trial in March and the clinical data will help set the dosing range for a phase 2 trial scheduled to begin this year.
Davunetide is derived from neuroprotective brain protein known as activity-dependent neuroprotective protein.
PSP affects the frontal and temporal lobes of the brain and is characterised by progressive difficulty with balance and walking, eye movement abnormalities, and cognitive and personality changes.
PSP has been associated with progressive disability and death with a median survival of up to eight years following onset.
About 50,000 people in the US and EU suffer from PSP.