GEN-003: Phase II data
Top-line data from a double-blind, placebo-controlled, U.S. Phase II trial in 310 patients with chronic genital HSV-2 infection showed that 30 and 60 ug intramuscular GEN-003 containing 25, 50 or 75 ug Matrix M given 3 times 21 days apart each met the primary endpoint of reducing viral shedding rate from baseline to the 28 days after completion of dosing. Specifically, low-dose GEN-003 plus 25, 50 and 75 ug Matrix M reduced viral shedding rate by 17%, (p<0.05), 38% (p<0.0001) and 36% (p<0.0005), respectively, and high-dose GEN-003 plus 25, 50 and 75 ug Matrix M reduced viral shedding rate by 44% (p<0.0001), 41% (p<0.0001) and 55% (p<0.0001), respectively. Patients receiving placebo achieved a 4% reduction in viral shedding rate from baseline. Additionally, low-dose GEN-003 plus 50 and 75 ug Matrix M (p<0.001 and p<0.0005, respectively) and high-dose GEN-003 plus 25, 50 and 75 ug Matrix M (p<0.0001 for all) each significantly reduced viral shedding rate vs. placebo. ...