Predix study indicates PRX-03140 may improve dementia in patients with Alzheimer's

By Angela McDaniels

Seattle, Nov. 14 - Predix Pharmaceuticals Holdings Inc. said that PRX-03140, its 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 14-day phase 1b clinical trial.

"The results of this Phase 1b trial in patients with Alzheimer's disease suggest that PRX-03140 is stimulating the 5-HT4 receptor in the brain and is eliciting the desired effects on brain waves consistent with approved drugs for Alzheimer's disease," vice president of clinical and regulatory affairs Stephen Donahue said in a company press release.

The phase 1b clinical trial was the second of two multiple-dose studies intended to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of PRX-03140 in 110 healthy volunteers and 12 Alzheimer's patients. Patients receive one dose of PRX-03140 or a placebo one daily.

The trial assessed the effects of PRX-03140 on quantitative electroencephalograms, 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, the company said.

In Alzheimer's disease patients, a specific EEG slow wave pattern has been linked with severity of dementia. Alzheimer's patients treated with PRX-03140 showed a statistically significant improvement in the quantitative EEG slow-wave pattern when compared with placebo.

Several positive studies of PRX-03140 in preclinical models for memory, cognition and disease modification are the subject of four poster presentations at the 35th Annual Meeting of the Society for Neuroscience in Washington, D.C., the company said.

Predix Pharmaceuticals has headquarters in Lexington, Mass., and Ramat Gan, Israel, and develops small-molecule drugs that target G-Protein Coupled Receptors and ion channels.

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