Predix Pharmaceuticals has announced that PRX-03140, its highly selective, proprietary serotonin 4 (5-HT4) receptor agonist, showed the desired alterations in brain wave activity in patients with mild-to-moderate Alzheimer's disease and was well-tolerated in a recently completed Phase Ib clinical trial.
The trial was the second of two multiple-dose studies with PRX-03140. The primary objectives of these randomized, blinded Phase Ib studies in both healthy subjects and patients with mild-to-moderate Alzheimer's disease were to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of the compound over a 14-day period. A total of 110 healthy volunteers and 12 Alzheimer's patients were enrolled in the trials.
The trial assessed the effects of PRX-03140 on quantitative electroencephalograms (EEGs), a measure of the electrical activity in the brain that has been used to characterize the effects of drugs that act on the central nervous system. In Alzheimer's disease patients, a specific EEG slow wave pattern has been linked with severity of dementia. With PRX-03140 treatment of Alzheimer's disease patients, there was a statistically significant improvement in the quantitative EEG slow wave pattern when compared with placebo. The short-term EEG effects observed with PRX-03140 treatment are similar to the published effects seen in patients that have an improvement in cognitive function after months of treatment with approved acetylcholinesterase inhibitor therapies for Alzheimer's disease. No change was seen in clinical parameters in the study.