Genocea says GEN-003 Phase 2 trial met primary endpoint
Genocea Biosciences announced positive top-line data from a Phase 2 dose optimization trial evaluating GEN-003 for the treatment of genital herpes. During the 28-day observation period immediately after completion of dosing, the best dose of 60 µg per protein / 75 µg of Matrix-M2TM adjuvant demonstrated a highly statistically significant 55% reduction from baseline in the viral shedding rate, the primary endpoint of the trial and a measure of anti-viral activity. All dose combinations tested, including the successful 30 µg per protein / 50 µg of adjuvant dose from the prior Phase 1/2a trial, demonstrated a statistically significant viral shedding rate reduction versus baseline and only the lowest dose combination did not demonstrate a statistically significant reduction versus placebo. In a planned secondary analysis to assess impact on patient-reported genital lesion rates, a self-assessed measurement of clinical disease, all dose groups, including the placebo group, demonstrated a statistically significant reduction from baseline. The Phase 2 study showed that GEN-003 was generally safe and well tolerated by patients, with no serious adverse events related to the vaccine. Safety data throughout the trial is monitored by an independent data safety monitoring board. Although reactogenicity increased with adjuvant dose, there was no difference in discontinuations in patient dosing due to adverse events across the different treatment arms.