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news.Prana Biotechnology Limited has commenced a phase I clinical trial of its Alzheimer's disease treatment candidate, PBT2, with the dosing of its first subject at a facility in The Netherlands.
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The phase I clinical trial is the first of a planned series of studies examining the safety and pharmacokinetics of PBT2 in normal human volunteers.
PBT2 is the first completely Prana-discovered compound, and is the successor to PBT1 for the treatment of Alzheimer’s disease. Both compounds are metal-protein attenuating compounds (MPACs) and PBT2 is designed to have an improved safety and efficacy profile compared to PBT1.
The compound has demonstrated significantly greater effectiveness in lowering plaque in the transgenic mouse model in both preclinical in-vitro and in-vivo testing. Moreover, it appears to be better than PBT1 at decreasing the toxicity of plaques through improved peroxide inhibition, and appears to have better pharmaceutical characteristics, such as improved solubility.
“We are extremely excited to be taking the first exclusively Prana-developed compound into the clinic,” said Dr Jon Alsenas, CEO of Prana.
This news is the company’s second significant milestone in the past three months, the other being the UK approval of a clinical trials authorization to begin a phase II/III study of PBT1.
The prize-winning science behind PBT2 is based upon what is known as ‘the metal theory’ of Alzheimer’s disease. The theory is based on the premise that key metals, such as zinc and copper, are required for the inappropriate aggregation of amyloid beta to form the amyloid plaques. These plaques are then thought to cause the neurodegeneration associated with Alzheimer’s disease.