ProteoTech's Exebryl-1 Enters Human Clinical Trials for the Treatment of Alzheimer's Disease
ProteoTech Inc. announced that it has completed regulatory Investigational New Drug (IND) requirements and has been cleared by the FDA to initiate its Phase 1 human clinical trial on Exebryl-1(R), a novel small molecule drug targeting toxic beta-amyloid protein accumulation for the treatment of Alzheimer's disease. ProteoTech initiated its Phase 1 human trial on July 29, 2008.
At the 2008 International Conference on Alzheimer's disease in Chicago, ProteoTech presented efficacy data in Alzheimer's transgenic mice, whereby Exebryl-1(R) lowered brain beta-amyloid protein load by greater than 30-50%, correlating with marked improvements in memory in these animals. Toxic and insoluble beta-amyloid protein accumulation is believed to be an important part of the disease progression and memory impairment observed in all patients with Alzheimer's disease. Data was also presented demonstrating oral bioavailability and blood-brain-barrier penetration of Exebryl-1(R).
Exebryl-1(R) is a small molecule drug developed at ProteoTech from its library of small molecule compounds designed to target specific amyloid diseases. Over six years of pre-clinical in vitro and in vivo testing led to the development of Exebryl-1(R) that is believed to prevent beta-amyloid protein formation, deposition, and accumulation at all stages of the disease progression. In addition, Exebryl-1(R) also contributes to a reduction and clearance of beta-amyloid protein deposits already existing in the brain as shown by a significant and marked reduction in brain amyloid plaques in older Alzheimer's transgenic animals.
Initial studies suggest that Exebryl-1(R) may also have an important dual capacity by inhibiting and reducing tau protein from forming paired helical filaments, important in neurofibrillary tangle formation. The presence of neurofibrillary tangles in brain containing tau protein is an important pathological hallmark of Alzheimer's disease. Further studies are ongoing to confirm these exciting findings. Thus, Exebryl-1(R) may be the first orally bioavailable small molecule drug that affects both amyloid plaque and neurofibrillary tangle accumulation, the two major characteristic and pathological lesions of Alzheimer's disease.
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