Predix Pharmaceuticals Initiates Phase Ib Clinical Trials of 5-HT4 Agonist for Alzheimer's Disease and Other Cognitive Disorders
Posted on: Wednesday, 30 March 2005, 09:00 CST
Predix Pharmaceuticals, a drug discovery and development company, today announced the initiation of two Phase Ib multiple dose studies with PRX-03140, its highly selective, proprietary serotonin 4 (5-HT4) receptor agonist intended to treat Alzheimer's disease and other disorders of memory and cognition. The primary objectives of the Phase Ib studies in both healthy subjects and patients with Alzheimer's disease are to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of the compound over a 14 day period.
"We have been particularly pleased with the tolerability and pharmacokinetics of PRX-03140 in our initial Phase Ia single dose study, which included young and elderly volunteers," said Stephen Donahue, MD, Vice President of Clinical and Regulatory Affairs. "We are moving the compound into two 14-day multiple dose studies. The first study may include more than 32 healthy volunteers. The second study, in patients suffering from Alzheimer's disease, will be initiated after the first study begins."
PRX-03140 is the Company's second clinical drug candidate discovered utilizing computer-generated GPCR models and optimized with integrated computational-medicinal chemistry. The compound has shown activity in four preclinical models of cognitive impairment, and in these studies PRX-03140 increased the levels of acetylcholine (ACh), soluble amyloid precursor protein (sAPP), and brain derived neurotrophic factor (BDNF) in regions of the brain known to be important for memory. Recent reports in the medical literature have also documented that stimulation of 5-HT4 receptors in the brain specifically increases the local release of ACh and may have neuroprotective properties through the production of sAPP. sAPP is a non-plaque forming, soluble amyloid precursor protein, with potential memory enhancing and neuroprotective properties.
About Alzheimer's Disease
Nearly one in 10 people over age 65 and as many as five in 10 people over age 85 have Alzheimer's disease (AD). Three out of the four drugs currently available for AD are acetylcholinesterase (AChE) inhibitors; the other is an NMDA antagonist which modulates neuronal firing. AChE inhibitors improve and maintain memory and thinking (cognition) and can delay disease progression temporarily in patients with early stage AD; however, these agents are not entirely effective in treating dementia symptoms or in slowing disease progression, as less than 50% of AD patients on AChE inhibitors show a modest improvement in symptoms.
AChE inhibitors are active provided that endogenous production of ACh is sufficient to maintain local levels. As AD progresses, ACh production declines, and brain levels of this critical neurotransmitter decline. In parallel with effective therapeutics in other neurodegenerative diseases (e.g., Parkinson's Disease), replacement of the prominent neurotransmitter lost in AD should provide significant clinical benefit. However, neither ACh nor its components can be given in sufficient quantities to increase brain ACh levels with tolerable side effects. The search for agents which increase the production and/or secretion of ACh, which can be used alone or in combination with acetylcholinesterase inhibitors, may therefore yield a drug candidate with significant clinical benefit.
About Predix
Predix is a privately held, clinical stage drug development company that uses a proprietary discovery and lead optimization platform to develop drugs for G-protein coupled receptor (GPCR) and ion channel targets. Over the past two years, the company has discovered several novel drug candidates, two of which are in human clinical trials. Predix has completed three Phase I trials and initiated a Phase II trial with PRX-00023, a 5-HT1A receptor agonist for depression and anxiety, as well as initiated a Phase I trial with PRX-03140, a 5-HT4 agonist for Alzheimer's disease and other cognitive disorders. Development of the company's robust pre-clinical pipeline continues, and a third drug candidate, a novel 5-HT2B antagonist for pulmonary hypertension and other hypoxia-associated diseases, is expected to enter the clinic in the first half of 2005. For more information on Predix, please visit www.predixpharm.com.
Source: Business Wire
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