Vaginal microbiota transplant: a novel method for treating bacterial vaginosis (BV)

Overview

Bacterial vaginosis (BV) is considered the most common cause of vaginal symptoms among women ages 15-44. The estimated prevalence of BV is between 25% and up to 50%. BV symptoms include vaginal discharge, itching and burning during urination. As a result, the quality of life is substantially affected, with an increased infection risk to the upper genital tract, sexually transmitted infections (e.g., HIV and herpes), complications of pregnancy, pre-term birth, and lower success in fertility treatments. Current available treatment of BV includes local or systemic antibiotics, as well as probiotics. However, these treatments show a relapse rate of over 50% within 3-6 months and 70% within 1 year. Moreover, repeating antibiotic treatment cycles might induce antibiotic resistance and predisposes treated patients to the risk of vaginal candidiasis. This insufficient treatment often leads to intractable, persistent or recurrent BV.

Our solution

Dr. Ahinoam Lev-Sagie, in collaboration with Prof. Eran Elinav of the Weizmann Institute of Science developed a treatment for BV through transplanting vaginal microbiome from healthy donor women into the vaginas of BV patients.  The transplantation protocol includes a through screening of the donors, to assure they lack BV symptoms for 5 years. The vaginal microbiome is then collected and transplanted in BV patients. 

Application

Market size

Between 25-50% of women of reproductive age suffer from BV globally, with 4.5% being recurrent and symptomatic. The annual global economic burden is estimated at $4.8B, with more than 50% of this cost attributed to recurrent BV. In addition, there are indirect costs which result from BV complications.

 

Development Status

In a controlled study, 5 women were treated with this protocol and were tracked for 1 year following treatment. 4 women underwent a complete remission with no apparent symptoms, and 1 woman showed partial remission. No adverse events were detected. The current focus is to conduct a larger scale clinical trial to determine wider applicability.

Intellectual Property

Patents filed in US, Europe and Israel (PCT WO/2021/038569)

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).