Genocea Biosciences Inc., a biopharmaceutical company that specializes in creating immunotherapies and vaccines for T cells, recently announced positive results from its Phase 2 trial of GEN-003, the company’s new treatment for genital herpes.
The top-line data from the dose optimization trial showed a 55 percent decrease of viral shedding rate from the baseline. The trial ended with an observation period of 28 days, which began immediately after the subjects received the doses. All dose combinations that were tested showed a significant viral shedding rate decrease versus baseline. Only the lowest amount of dose combination did not show a significant decrease versus placebo.
A planned secondary analysis used a self-assessed measurement to determine the improvements of patient-reported genital lesion rates. All of the dose groups as well as the placebo group showed a significant decrease from the baseline.
“We are extremely pleased with these positive top-line results which have successfully allowed us to identify the optimal dose to advance into further trials,” Genocea Biosciences CEO and President Chip Clark said. “The results strengthen the product profile from our Phase 1/2a trial, which we have shown in market research to be highly clinically meaningful and commercially attractive, providing further evidence of the strong value proposition of GEN-003 for patients, physicians and payers.”