Predix Pharmaceuticals, which recently announced a definitive agreement to merge with EPIX Pharmaceuticals, announced that it has initiated a phase I clinical trial in 18 healthy adult male and female volunteers to study the safety, tolerability, and pharmacokinetics of PRX-07034, a serotonin 5-HT6 antagonist being developed for the treatment of obesity and also for cognitive impairment (associated with Alzheimer's disease or schizophrenia).
"PRX-07034 is the fourth novel drug candidate emerging from our discovery platform and progressing rapidly into human clinical trials," said Michael G. Kauffman, M.D., Ph.D., president and CEO of Predix Pharmaceuticals. "This particular candidate selectively targets the serotonin 5-HT6 protein receptor, which is found primarily in the brain with little or no expression in peripheral tissues. We expect to announce the results from this Phase I trial later this year."
PRX-07034 is a novel, highly selective, small-molecule antagonist of a specific G-protein coupled receptor (GPCR) known as 5-HT6. PRX-07034 has shown cognitive-enhancing properties in pre-clinical animal models of memory impairment, as well as significant reductions of both food intake and body weight in several pre-clinical animal models of obesity. Indications are that the human 5-HT6 receptor is found mainly in the central nervous system with little or no expression in peripheral tissues, which may result in selectivity in drug targeting with fewer side effects.