announced positive results Tuesday from a phase III study on antidepressant Vilazodone that also identified potential genetic markers for patient response to the drug.
The company said the study singled out candidate biomarkers for a possible companion pharmacogenetic test for response to Vilazodone. Such a test would determine pretreatment the likelihood that a patient would respond to the drug with the goal of guiding more accurate prescribing by making clinical outcomes more predictable.
Vilazodone combines a selective serotonin reuptake inhibitor (SSRI) and a 5HT1A partial agonist -- first- and second-line treatments -- for mood disorders. Clinical data said about one-half of depressed patients don't have satisfactory results with current first-line treatment options. Thus, the company believes an accompanying genetic test would help physicians match patients with a treatment more likely to be effective.
Trial data suggest Vilazodone's safety profile was similar to currently marketed SSRIs, according to the company.
"We look forward to meeting with the FDA to discuss our remaining clinical trials program in support of our NDA
new-drug application filing on this important new therapeutic candidate and on a potential genetically based companion diagnostic," Drew Fromkin, president of Clinical Data, said.
Shares were up $1.09, or 4.2%, to $27.09.