Microbiome Therapeutic for Treating Bacterial Vaginosis

Background and Unmet Need

Bacterial Vaginosis (BV) is considered the most prevalent form of vaginal infection in women of reproductive age,
affecting from one-quarter to one-third of women. Women suffering from BV report diminished quality of life from
symptoms that typically include abnormal, often malodorous vaginal discharge. Additionally, BV increases the risk
of upper genital tract infection, sexually transmitted infections (STI), such as HIV and Herpes, complications of
pregnancy, pre-term birth, and lower success in fertility treatments. Treatment with antibiotics (either systemic or
vaginal) remains disappointing; with a 30% relapse rate of symptomatic BV within three months of initial treatment,
and up to 50-70% within a year. Moreover, chronic or frequent antibiotic treatment predisposes treated patients to
the risk of vaginal candidiasis. Many women therefore suffer from intractable, persistent or recurrent BV with very
limited therapeutic options.

The Solution

The group of Prof. Eran Elinav in collaboration with Hadassah hospital in Jerusalem has developed a potential cure
for BV by transplanting the vaginal microbiome of healthy women to those afflicted with BV.

Technology Essence

The collaboration between the Elinav group and Hadassah hospital generated a protocol to transplant microbiome
from healthy donors into afflicted women (Fig. 1). Donors were screened for a variety of factors including general
health and lacking symptoms of BV for at least 5 years. Vaginal microbiomes were then collected and transferred to
women diagnosed with BV. In controlled study women who underwent transplantation were tracked for one year to
determine the efficacy of a single treatment and to determine whether additional vaginal microbial transplants were
needed. Lastly, the vaginal microbiomes of the recipients were 16s rDNA sequenced to determine compositions of
bacterial populations.

Advantages and Advantages

A method for treating bacterial vaginosis
The treatment does not involve antibiotics and does not have the potential for causing or spreading
antibiotic resistance
The method also acts a way to determine who is a viable donor based on the population composition of the
vaginal microbiome

Development Status

The current results include clinical results in a cohort of five women with BV, who were tracked for 5-21 months
following VMT. Four out of five women showed remission of BV with no symptoms, with the fifth showing
incomplete remission. None of the five women showed any adverse effects from the VMT. Current focus is to
perform a larger scale clinical trial to determine wider applicability.
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References: Lev-Sagie, A., Goldman-Wohl, D., Cohen, Y. et al. Vaginal microbiome transplantation in women with
intractable bacterial vaginosis. Nat Med 25, 1500–1504 (2019).
Clinical Trial Identifier: NCT02236429