Women’s health biotech Freya Biosciences will advance an immunotherapy for a bacterial imbalance in the vagina into patients undergoing in vitro fertilization after early-stage results showed resolution of the condition.
Freya’s lead compound, FB101, was administered over three consecutive days in a phase 1 study of women with asymptomatic vaginal tract dysbiosis. The condition is characterized by the loss of dominance of the Lactobacillus bacteria in the vagina and an increase in microbiota diversity. This can lead to various diseases, including bacterial vaginitis, vulvovaginal candidiasis, human papillomavirus, herpes simplex virus-2 and many more, which take advantage of the less protective environment.
The imbalance can also lead to miscarriages, preterm birth or infertility—and that’s where Freya is hoping to make a difference.
Freya was testing to see whether FB101 could resolve the dysbiosis and reestablish Lactobacillus, keeping the bacteria sustained over eight weeks. The therapy did just that, but also showed that the FB101 Lactobacilli species was established in half of the women. Freya also noted a change in inflammatory markers.
Now, FB101 will advance into clinical testing for patients undergoing IVF procedures to see whether it can boost fertility treatment outcomes and success rates. Asymptomatic vaginal dysbiosis is often flagged in women undergoing IVF and can impact treatment success, Freya said in a Tuesday release.
The study was conducted in Europe in conjunction with a cohort at Boston IVF.