Microbiome transplant to treat vaginal tract dysbiosis clears phase 1 milestone

The trial​ recruited 34 healthy women who were identified to have vaginal dysbiosis by sequencing the DNA of bacteria in a vaginal swab sample. One group of participants received Freya’s microbiome treatment FB101 on 3 different days and the other received a placebo. The participants’ vaginal microbiomes were then monitored for 6 months following the first dose.

According to the trial results, Freya’s microbiome treatment boosted the amount of lactobacilli in the vaginal microbiome of the participants. This rebalancing lasted for more than 8 weeks. The microbiome treatment was successfully engrafted in half of the participants and the investigators found signs that the treatment changed markers of inflammation in the participants.

Colleen Acosta, CEO of Freya Biosciences, welcomed the initial results in a public release, adding that they “give strength to our platform and lay the groundwork for further pipeline programs with Freya’s immunotherapeutic candidates for other conditions within the women’s health area.”

According to Freya’s website, around 1 in 10 couples grapple with infertility and undergo many cycles of in vitro fertilization (IVF).

"Data from a cohort study conducted in collaboration between Freya and a major U.S. clinic, Boston IVF, support the concept of lower pregnancy rates in women with a dysbiotic inflammatory vaginal microbiome compared to women without this condition when undergoing IVF,” said Joan-Carles Arce, Chief Medical Officer of Freya in the public release.

“We look forward to advancing the clinical development program with FB101, which has the potential of becoming the first targeted therapy for the IVF population with vaginal dysbiosis.”

Freya’s lead candidate FB101 consists of a transplant of vaginal microbiota derived from healthy donors. The majority of the healthy microbes from the vaginal microbiome are bacteria from the Lactobacillus​ genus and reduced lactobacilli can lead to an imbalance in the microbiome. By giving women these transplants, the company aims to boost the amount of lactobacilli in their vaginal microbiome and return it to a healthy state.

With the phase 1 results in hand, Freya is preparing to launch phase 2 trials of the treatment in women seeking infertility treatment and undergoing IVF. The trials are expected to be completed by around 2025. Freya is also developing candidates to tackle preterm birth and infertility caused by endometriosis.

The microbiome field is gaining momentum in the biotech industry. The first microbiome therapeutic, Rebyota, based on rebalancing the gut microbiome, was approved by the U.S. Food and Drug Administration (FDA) in late 2022 for the prevention of recurrent C. difficile​ infections. Meanwhile, the first oral gut microbiome therapeutic, named Vowst, gained the FDA green light earlier this year​.