Prana Biotechnology has received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for a composition of matter patent for selected 8-hydroxy quinazolinone  compounds, including its lead Parkinson’s disease (PD) drug candidate, PBT434, in the United States.  

The patent entitled ‘Neurologically Active Compounds’ also covers pharmaceutical compositions containing PBT434 and selected 8-hydroxy quinazolinone compounds.

Once granted, the United States patent has a twenty year term expiring June 7, 2026.  This expiry date may in the future be further extended by the application of  pharmaceutical extension of term provisions of up to five years in the United States.  

Geoffrey Kempler, Prana’s CEO, said “securing granted rights to our lead PD drug  candidate furthers our commercialization plans for PBT434 for which Prana was recently awarded a grant from The Michael J. Fox Foundation to undertake preclinical development studies to enable human clinical trials”.

PBT434 has been designed to prevent or slow the loss of the neurons of the substantia nigra that produce the chemical dopamine, the neurotransmitter that controls motor function in the brain.  As a neuroprotective agent, PBT434 preserves critical interneuronal connections between the substantia nigra and the striatum (neurons which have dopamine receptors and transmit the signals to coordinate movement pathways and a variety of cognitive processes involving executive function).  Experiments in two animal models of PD have shown that; in animals treated with PBT434, motor coordination and performance were significantly improved compared to untreated control animals, the characteristic accumulation of the disease associated protein alpha synuclein in the brains of PD animal models was reduced and that expression of a key genetic susceptibility factor, the antioxidant protein, DJ-1, was elevated in  substantia nigra neurons.