Pipeline
PGxHealth has a pipeline of early and late stage targeted therapeutics. Each therapeutic program seeks to leverage the Company’s expertise in drug development and biomarker discovery to produce drugs that can be differentiated in their category. Upon commercialization, these therapeutics may provide patients, physicians and payers with advantages over existing therapies. Vilazodone, a novel dual-acting serotonergic antidepressant, is a potent and selective serotonin reuptake inhibitor (SSRI), and a partial agonist of the 5-hydroxytryptamine 1a (5-HT1A) receptor. Vilazodone combines first-line SSRI therapy for Major Depressive Disorder (MDD) with 5-HT1A partial agonism, an accepted adjunctive treatment for MDD, and a first-line therapy for anxiety disorders. Positive top-line results from the second Phase III trial were announced in June 2009.  In the study, vilazodone achieved statistically significant results on the primary endpoint and secondary efficacy endpoints related to MDD. Study results suggest that vilazodone was generally well-tolerated and the efficacy and safety data were consistent with the findings from the previous Phase III trial. In addition, study findings corroborate that effects of vilazodone on sexual function were comparable to placebo as measured by validated scales, an important finding since many antidepressants have been associated with causing or exacerbating sexual dysfunction. A statistically significant improvement in the symptoms of anxiety associated with MDD was also observed.  Stedivaze is a highly selective and potent agonist of the adenosine A2A receptor for use as a coronary artery vasodilator in pharmacological stress imaging. Both Vilazodone and Stedivaze are poised to successfully compete in large and growing markets. The Company’s early-stage therapeutic pipeline contains other highly targeted compounds for indications where there is a great  need for more effective therapies.