Allon Therapeutics Inc. announced that a Phase 1 clinical trial of its lead neuroprotective drug, davunetide, which began patient enrollment January 28, 2010, has been completed. The results demonstrated that the intranasal dose range can be broadened and provided additional information on the pharmacokinetic profile of davunetide.
Gordon McCauley, President and CEO of Allon, said the results confirm davunetide’s safety and expands the doses that can be used in future clinical trials. The Company’s previous Phase 2a clinical trials successfully demonstrated human efficacy in patients with schizophrenia and in patients with amnestic mild cognitive impairment (aMCI), a precursor to Alzheimer’s disease.
“These Phase 1 results fully support our dosing plans for a Phase 2 clinical trial that will evaluate davunetide as a treatment for Progressive Supranuclear Palsy (PSP), a rapidly-progressing and fatal degenerative brain disease,” McCauley said.
The randomized, double-blind, placebo-controlled Phase 1 study evaluated the multi-dose safety, tolerability and pharmacokinetic profile of davunetide in 10 healthy adult subjects aged 45 to 65 years. Davunetide was administered at a dose up to 60 mg per day, and was found to be generally well tolerated with no serious adverse events reported. The number of treatment emergent AEs were small with a similar number reported in the placebo and the high dose groups. These clinical results support the advancement of davunetide at higher dosage levels in the treatment of neurodegenerative diseases such as Alzheimer’s disease, schizophrenia and PSP.
Allon announced January 12, 2010 that the United States Food and Drug Administration (FDA) granted Orphan Drug Designation to davunetide for the treatment of PSP. PSP is a one of several dementias classified as a frontotemporal dementia (FTD).
Approximately half of dementias diagnosed as FTD, including PSP, have a common pathology in which brain cells are damaged by impairment of the brain protein tau. Allon’s preclinical studies and Phase 2a clinical trials have shown that davunetide is active in treating diseases known to have impaired tau function, leading to restoration of brain cell health. Allon expects that efficacy in PSP would define the opportunity to use davunetide in other FTD subtypes that are tauopathies.
Date: March 11, 2010
Source: Allon Therapeutics Inc.
