Allon Therapeutics Inc., the Neuro Protection company, has released new data confirming that the company's product AL-309 has robust oral bioavailability in preclinical studies. This new data also shows that AL-309 enters the brain and that effective concentrations can be detected for extended periods of time. This information serves to confirm the potential of AL-309 as a highly novel central nervous system drug.
Gordon McCauley, president and CEO of Allon, said, earlier preclinical studies demonstrated that AL-309 had neuroprotective effects in several animal models of neurodegenerative disease.
"These new results are quite significant as they show that AL-309 passes through two meaningful barriers to drug delivery: the intestinal wall and the blood-brain barrier (BBB). These characteristics are essential for an orally administered central nervous system drug and validate the company's programme to develop AL-309 as a treatment for neurodegenerative disease," McCauley said.
McCauley said AL-309 will be the first product to move into clinical development from the company's second platform of neuroprotective compounds. AL-309 will complement development of AL-108 and AL-208, which are currently being evaluated in phase II clinical trials as treatments for Alzheimer's disease and for mild cognitive impairment associated with coronary artery bypass graft surgery. A third phase II trial will begin in mid-2007 to evaluate AL-108 as a treatment for schizophrenia-related cognitive impairment.
Allon's two technology platforms are based on neuroprotective proteins that are formed naturally in the brain, namely activity-dependent neuroprotective protein (ADNP) and activity-dependent neurotrophic factor (ADNF). AL-108 and AL-208 use an eight amino acid peptide derived from ADNP. AL-309 is a nine amino acid fragment of ADNF, modified for additional stability.
The BBB refers to the capillaries that protect the brain from harmful substances in the blood stream. Unlike capillaries throughout the rest of the body that allow relatively free exchange of substance between cells, the BBB strictly limits transport into the brain and is often the rate-limiting factor in determining permeation of therapeutic drugs into the brain.