Antibiotics-free treatment for vaginal infections
Bacterial vaginosis (BV) and vulvovaginal candidiasis (VVC) are common vaginal infections caused by bacteria, often Gardnerella, or yeast (a fungus) called Candida. All treatments available to date involve either antibiotics or antifungals. Due to prolonged usage, misdiagnosis and overconsumption, there is a high incidence of drug resistance, which the WHO considers one of the biggest threats to global health.
Taking the vaginal microbiota into account
In common with other organs, including the well-publicised gut and skin, the vagina has a microbiome of bacteria and fungi. An imbalance in the microbial profile driven by inappropriate use of antimicrobials may lead to inflammation and the possibility of further infection. The Swedish company GEDEA Biotech AB have developed a vaginal tablet for treating yeast and bacterial infections while keeping the vaginal microbiota intact. The tablet contains the natural substance glucono-δ-lactone, key to a completely new approach towards a healthy vaginal microbiota. The formulation, known as pHyph, restores and maintains vaginal pH, elevated during infection, and disrupts the Candida and bacteria biofilm without causing treatment resistance. At the same time, it promotes the growth of beneficial lactobacilli, important for a healthy vaginal microbiome and prevention of recurrence of the infections. Now, with funding from the EU through the NEFERTITI project, trials prior to launching pHyph on the EU market are complete. The CEO of GEDEA Biotech and NEFERTITI project coordinator Annette Säfholm explains: “The core objectives of the NEFERTITI project were to fine tune the formulation of pHyph, followed by a full clinical testing programme to demonstrate its efficacy in treating vaginal infections and preventing their recurrence as well as confirming its safety.”
A permanent solution for the persistent problem of antimicrobial resistance
pHyph has shown a cure rate for BV in line with many antibiotic products on the market but with substantially less recurrence and no secondary VVC infections. VVC and BV are both major issues for women’s health. They cause intense discomfort and physical pain along with psychological distress. pHyph relieves the physical symptoms associated with vaginal infections. Säfholm outlines the extent of the success in the trials: “Symptom reduction was seen in 90 % of patients, and absence of symptoms was noted in 70 % of patients in the clinical trial. The rate of recurrence of BV was substantially lower at day 35 with pHyph (13.9 %) compared to the placebo (27 %) and throughout the 4-month follow-up period.”
Future steps for pHyph and a key role in keeping a healthy vaginal microbiome
The GEDEA Biotech team aim to put pHyph on the market in Sweden and the rest of Europe. The researchers are collating the necessary documentation for CE marking. They also plan to initiate phase 3 trials for future FDA approval in the United States. “In parallel, we have interesting data indicating that pHyph promotes a healthy vaginal microbiome, which has far-reaching implications,” reports Säfholm. A healthy microbial profile has been shown to be important for other indications such as prevention of preterm birth.” “pHyph is a very strong candidate to take the place of antimicrobials. We strongly believe that pHyph will replace antibiotics as the first in line treatment for BV for many patients,” emphasises Helena Strevens, medical director at GEDEA Biotech and senior gynaecologist.
Keywords
NEFERTITI, pHyph, BV, vaginal infection, Candida, antibiotics, resistance, vaginal microbiome, bacterial vaginosis