- Genocea Biosciences released positive 12-month Phase 2b topline results for its genital herpes immunotherapy yesterday, lifting its stock price by over 15%.
- In a study of 131 patients with recurrent genital herpes, the median genital lesion rate (as measured by percent days with lesions) fell by 49% against placebo (p=0.01) at the 60 mcg per antigen/50 mcg of adjuvant dose. The results are consistent with earlier Phase 2 data.
- The Phase 3 study is planned for the second half of 2017, using the 60 mcg per antigen/50 mcg of adjuvant dose, with median genital lesion rate as the endpoint.
"We are confident in our level of preparedness for our Phase 3 trial. We need the final FDA sign off on the protocol and we are confident that we can start the trials this year," said Chip Clark, president and CEO of Genocea, on a conference call about the Phase 2b results.
Data released In September 2016 showed that the study had reached its Phase 2b primary endpoint of a statistically significant reduction of 40% in the rate of viral shedding in the 60 mcg per antigen/50 mcg of adjuvant dose group, compared with both baseline and placebo.
As well as the Phase 3 trial, Genocea is planning a maintenance dosing study, along with studies looking at the safety and benefits of GEN-003 in combination with antivirals with different modes of action.
"We don't have any combination data yet, but we believe that the efficacy should be additive. Our planned 600-patient study should allow us to tease out the difference," said Clark.
Genocea is looking for commercialization partners, and also for support for future Phase 3 trials.
"We are having an ongoing dialog with potential partners, and we will do the deals that are right for Genocea," said Clark. "Our sweet spot is the U.S., so we will especially look for help with regulatory and commercial issues in the rest of the world. But we will also look for partners in the U.S."
Genocea describes GEN-003 as a "potential new cornerstone treatment for patients with genital herpes," with "potential to be first new treatment option in more than 20 years."
Other companies have tried to bring treatments forward for condition, which is highly prevalent, but have failed due to lack of understanding of the disease. Genital herpes is a common condition, but most people never experience an outbreak and therefore have no idea that they have the condition. There is little understanding about how easily it is transmitted and why some patients show more severe symptoms.
Currently one of the only treatments on the market for the condition is the generically available Valtrex (valacyclovir), which helps shorten outbreaks, but does not cure the condition.