The data from Genocea Biosciences’ Phase IIb clinical trial for the company’s herpes drug candidate have just been released, and it looks like the biopharmaceutical firm will be pushing the immunotherapy into Phase III. The 12-month trial returned statistically significant results on its primary endpoint, along with promising results on secondary measures.
The Phase IIb clinical trial involved 131 participants and found that the experimental herpes immunotherapy GEN-003 reduced the percent days with genital lesions – also known as the median genital lesion rate – by 49 percent, compared to a placebo group. According to a press release issued by Genocea, this primary endpoint and the dose tested will likely be the same in Phase III clinical trials.
“We believe these data further solidify the strong clinical profile for GEN-003,” said Chip Clark, President and CEO of Genocea, “which could provide durable, convenient efficacy to a large and, we believe, highly dissatisfied patient population and serve as a cornerstone treatment of this burdensome disease.”
According to the Centers for Disease Control and Prevention (CDC), around 776,000 people in the US are infected with herpes each year. Because herpes can be asymptomatic in some patients, many may be unaware that they are infected.
“These data and the continued progress of GEN-003 show the potential of this immunotherapy to change the treatment paradigm for patients with genital herpes infections,” said Jonathan Temte, M.D., Ph.D., M.S., former chair of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP). “The benefits of using a periodic immunization to achieve fewer and shorter genital herpes outbreaks without the compliance challenges of a daily pill burden would represent an extremely important alternative for patients with genital herpes.”
GEN-003 is designed to elicit an immune response that involves both T cells and B cells. The drug is a first-in-class immunotherapy which includes two antigens, ICP4 and gD2.
GlaxoSmithKline’s Valtrex (valacyclovir) is currently one of the only medications approved to control herpes outbreaks. If approved, GEN-003 could be the first new treatment option for genital herpes in over 20 years.