Allon's Phase 1 Trial Broadens Davunetide's Intranasal Safety And Dose Range

Allon Therapeutics Inc. (TSX:NPC) announced today that a Phase 1 clinical trial of its lead neuroprotective drug, davunetide , which began patient enrolment 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.


About davunetide


Davunetide is derived from a naturally occurring neuroprotective brain protein known as activity dependent neuroprotective protein (ADNP). Allon's laboratory and animal studies have shown that davunetide improves cognition in a number of disease models through a mechanism believed to involve effects on structures in the brain - known as microtubules which are critical to communication between brain cells and the structure of individual cells.


In 2008, Allon reported Phase 2a clinical trial results showing that davunetide had a statistically significant positive impact on memory function in patients with amnestic mild cognitive impairment (aMCI), a precursor to Alzheimer's disease (AD). The data was presented July 28 and July 30, 2008 to the International Conference on Alzheimer's Disease and Related Disorders (ICAD 2008).


On December 7, 2009, Allon reported Phase 2a clinical trial results showing that davunetide improved memory function of schizophrenia patients and had a positive impact on the ability of these patients to carry out important activities in their daily lives. The data was presented at the annual meeting of the American College of Neuropsychopharmacology.


About Allon's neuroprotective platforms


Allon's two neuroprotective technology platforms are based on two naturally occurring proteins produced by the brain in response to a range of insults. The platforms are activity-dependent neuroprotective protein (ADNP) and activity-dependent neurotrophic factor (ADNF).


Because the two platforms are based on different proteins, the drugs from each are different molecules with different therapeutic mechanisms and distinct commercial opportunities. Clinical-stage drugs based on davunetide are derived from ADNP, while preclinical stage drug AL-309 is derived from ADNF. Davunetide is focused on Alzheimer's disease, cognitive impairment in schizophrenia, and frontotemporal dementia.


ADNF drug candidate AL-309 is being developed for the treatment of peripheral neuropathies and is administered orally or subcutaneously.


Source

Allon Therapeutics Inc.