Allon Therapeutics is currently enrolling patients in a phase 2/3 study for its lead neuroprotective drug candidate, davunetide, a treatment for progressive supranuclear palsy (PSP), a form of frontotemporal dementia (FTD). Allon has completed two phase 2a human efficacy studies for davunetide in patients with amnesic mild cognitive impairment (aMCI), a precursor to Alzheimer’s disease, and in patients with cognitive impairment associated with schizophrenia (CIAS).
This phase 2/3 double-blinded, placebo-controlled trial will enroll approximately 300 patients randomized 1:1 to receive either placebo or 30 mg of davunetide intranasally twice daily for 12 months. This multi-national study is being conducted at premier medical institutions in the U.S., Australia, Germany, France, Canada and the U.K.
The primary outcome measures will be the progressive Supranuclear Palsy Rating Scale (PSPRS) and the Schwab and England Activities of Daily Living (SEADL) scale. Secondary measures will include Clinical Global Impression (CGI) and brain imaging by magnetic resonance tomography (MRI). Additional exploratory endpoints include cognitive and executive function as well as cerebrospinal fluid (CSF) biomarkers.