MONDAY, JUNE 25, 2018

Positive interim results for PaxVax cholera study

PaxVax, Inc., a Menlo Park, California-based vaccine developer, announced positive interim results on Thursday for the Phase III cholera challenge study of its PXVX0200 vaccine candidate.

The study investigated the rate of diarrhea in participants vaccinated with PXVX0200 compared with individuals receiving only the placebo. Twenty of 33 participants receiving the placebo experienced moderate-to-severe diarrhea compared to just two of 35 participants who received PXVX0200.

The first group was challenged with cholera at 10 days after vaccination. As part of the study, a second, separate group of volunteers will be challenged 90 days after vaccination. Final study results will combine both challenge time points at 10 and 90 days after vaccination.

"As a result of favorable data reported from the 10-day challenge component we will continue with the Phase III program, and look forward to additional positive results that will provide the evidence-base to support a biologics license application for PXVX0200, our lead vaccine candidate," Ken Kelley, the CEO of PaxVax, said. "We are excited about the prevailing opportunity to protect U.S. travelers from cholera, and also believe that PXVX0200 may allow us to bring a logistically simple, single-dose cholera vaccine to developing countries for use during explosive cholera outbreaks."

Cholera is an acute intestinal diarrheal infection caused by Vibrio cholerae bacteria, which is typically acquired by ingesting contaminated food or water. According to the World Health Organization, cholera causes an estimated three to five million cases per year. The disease kills 100,000 to 130,000 people annually worldwide.

A cholera vaccine is not currently available for U.S. residents who travel to high-risk areas.