- Genocea Biosciences (NASDAQ:GNCA) announces positive 12-month top-line data from the Phase 2b clinical trial for GEN-003, its immunotherapy candidate for patients with genital herpes.
- In this 131-subject Phase 2b clinical trial, GEN-003 reduced the median genital lesion rate versus placebo by 49% and 37% and the median number of recurrences versus placebo by 63% and 50% over the 12 months’ post dosing at the 60 µg per antigen / 50 µg of adjuvant dose and 60 µg per antigen / 75 µg of adjuvant dose, respectively.
- Importantly, these results were achieved at the Phase 3 dose and expected Phase 3 primary endpoint. Other clinical endpoints for this dose improved or were consistent with previously reported positive data. No changes were observed to the previously established safety profile of GEN-003.
- Genocea management will host a conference call and webcast at 8 a.m. ET to review these data.
- In September 2016, Genocea reported that the trial achieved its primary endpoint, with GEN-003 demonstrating a statistically significant reduction in the rate of viral shedding in the 60 µg per antigen / 50 µg of adjuvant dose group compared to both baseline and placebo.
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