On the heels of successful Phase II data for its genital herpes candidate, Genocea ($GNCA) reported that its pneumococcal vaccine missed the mark in Phase II. Now, the Cambridge, MA-based company is putting its pneumococcal vaccine on the back burner so it can focus its resources on the more successful herpes jab.
Top-line data from the Phase II trial of Genocea's vaccine for pneumococcal infection, GEN-004, showed that it failed to meet both of its primary endpoints.
The randomized, double-blind, placebo-controlled study involved 98 healthy adults, all of whom received three doses of GEN-004 or placebo at four-week intervals. They were then inoculated intranasally with pneumococcus serotype 6B bacteria. Although the vaccine outperformed placebo in reducing the colonization rate of the bacteria, it failed to do so in a statistically significant way.
The company is working with advisers to figure out the next steps for its pneumococcus program.
|Genocea CEO Chip Clark|
"While we did not hit statistical significance in this study, the consistent apparent effect gives us confidence in the vaccine concept and in the potential for GEN-004," CEO Chip Clark said in a statement. "At this time, we believe it is possible that future trials would require a change in some combination of dose, adjuvant or trial population to confirm any effect."
For the time being, Genocea is focusing on the herpes candidate, GEN-003, which reduced viral shedding by 58% in a Phase II trial involving 310 participants. The company is planning to start Phase IIb trials by year's end and hopes to bring the candidate into Phase III in 2017.
- here's the release
- and here's FierceBiotech's take