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news.Epix Pharmaceuticals has begun testing in a phase IIa clinical trial to further evaluate PRX-03140 as a monotherapy and in combination with donepezil for the treatment of Alzheimer's disease.
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This phase IIa trial is designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of PRX-03140 administered orally once-daily for 14 days in patients with mild Alzheimer's disease who are on a stable dose of donepezil. Data from this trial are expected in the second half of 2007.
“This phase IIa trial is designed to build on the promising results observed in our phase Ib trial, in which treatment with PRX-03140 resulted in the desired changes in brain wave activity in patients suffering from Alzheimer's disease,” said Michael Kauffman, CEO of Epix Pharmaceuticals. “To date, our data indicate that PRX-03140 stimulates acetylcholine production in the brain without the peripheral side effects commonly seen with currently approved drugs.”
PRX-03140 is selective for the 5-HT4 receptor in the brain, and preclinical studies have shown that it improves cognitive function, as well as increases levels of acetylcholine, soluble amyloid precursor protein and brain-derived neurotrophic factor in regions of the brain known to be important for memory.