Evofem enrolls first patient in Amphora Gel vaginal Ph trial
Evofem, a biotechnology company focused on the development and commercialization of women's health products, has announced that patient enrollment has begun in their clinical study that will evaluate the effect and duration of Evofem's proprietary vaginal gel, Amphora for bacterial vaginosis (BV), on vaginal pH.
BV is an infection caused by an imbalance of bacteria in the vagina and is the most common vaginal infection in women ages 15-44. The etiology and pathogenesis of BV are not completely understood, and it is unclear whether the rise in vaginal pH that accompanies BV is a cause or effect of the microbial imbalance. Treatment of BV with antiobiotics often fails to correct the micro flora imbalance, therefore recurrence of BV is common. Current research suggests that Amphora for BV works through a novel mechanism of action with potential efficacy in helping to restore and maintain the proper balance of beneficial bacteria in the vagina.
"This proprietary vaginal gel is an acidity-maintaining gel which lowers the vaginal pH. With the first patient enrolled in the trial, we will be collecting data to determine the duration of its effect and the impact on the vaginal microbiome which will inform the design of future clinical trials," said Dr. David Friend, Ph.D., senior vice president of R&D and Technical Operations of Evofem.
"Millions of women suffer from the recurrence of bacterial vaginosis," said Saundra Pelletier, Evofem CEO. "Our innovative vaginal gel has the potential to be an important new treatment option for this pervasive issue that impacts the quality of life for so many women."