Women’s health company Gedea Biotech is moving towards approval for its antibiotic-free treatment for bacterial vaginosis following positive results from its NEFERTITI clinical study.

NEFERTITI is a placebo-controlled, double blind clinical trial performed in Sweden and UK in 150 patients of Gedea Biotech’s lead product, pHyph, a vaginal tablet for topical treatment of bacterial vaginosis (BV).

Bacterial vaginosis is the most common vaginal infection and affects around 10-30% of women of reproductive age. It is a condition of the vagina caused by excessive growth of resulting in an imbalance of the naturally occurring bacteria in the vagina and disturbing symptoms that affect daily life in many ways, including a vaginal discharge, a fishy odour and sometimes burning pain.

The condition is treated with antibiotics and/or antiseptic treatment products, but recurring bacterial vaginosis is common and treatment with antibiotics often induces vulvovaginal candidiasis. Approximately 8 million prescriptions of antibiotics are currently issued each year for BV in the US and in the EU combined.

The treatment is a vaginal tablet taken once daily for 6 days at home. Already on the first day after pHyph treatment, a pronounced reduction of fishy smell, the most disturbing symptom of BV, was observed and after treatment, 70% of patients were completely free of the symptom, with 90% of patients experiencing alleviation. pHyph treatment resulted in 50.4% cure rate after 6 days, (n=115).

The placebo treatment reduced BV symptoms, although later and to a lower degree than pHyph. The cure rate for the placebo treatment was 46.6% (n=30) and it was impacted by an unexpected effect of the placebo (tablet) filling material in promoting the growth of lactobacilli, subsequently causing a pH reduction, and relieving the BV symptoms, a finding which led to a new patent filing.

Furthermore, pHyph treatment showed a considerably lower recurrence rate compared to placebo, though not statistically significant, both at day 35 (pHyph: 13.9%, Placebo: 27% and among patients having taken Metronidazole (antibiotics) as rescue treatment: 47.5%) and throughout the four-month study period. Further analysis on occurrence of vaginal dysbiosis is planned as well as a scientific article on the full analysis results.

No patient on pHyph treatment experienced secondary vulvovaginal candidiasis infections during the follow-up period while 1 patient (2,8%) was diagnosed in the placebo group and at least 3 patients (7,5%) among patients given rescue antibiotic treatment, even though adverse event reporting wasn’t required for this group. There were no Serious Adverse Events observed among patients receiving pHyph treatment, and no safety concerns.

Based on these results the company now continues the process for European CE mark approval of pHyph and further on, plans for initiating phase 3 trials for subsequent FDA approval in the USA.

Dr. Helena Strevens, MD, PhD, Senior Consultant, Associate Professor, said: “We do have standard antibiotic treatments for bacterial vaginosis, which usually work quite well in the short term, but there is a very high rate of recurrence. Women often have to take multiple courses of antibiotics to keep symptoms away.

”This of course contributes to the global problem of antibiotic resistance. A non-antibiotic treatment preventing recurrence would be a major step forward. The fact that pHyph relieves symptoms almost immediately is very appreciated among patients.”

Dep of Obstetrics and Gynecology, Skåne University Hospital. Annette Säfholm, Gedea Biotech’s CEO,said: “We are happy to finally report the results from the NEFERTITI study and to take the next important step towards making pHyph available for women in the world. The NEFERTITI trial was conducted during the challenging times of Covid-19 and I´m impressed by the dedicated work of the investigators and their teams in managing to complete the study.

”The data confirms that treatment with pHyph has several advantages compared to current treatment options; the rapid and high degree of symptom reduction, lower recurrence rates and that it does not induce secondary fungal infection. We strongly believe that pHyph will replace antibiotics as the first in line treatment for bacterial vaginosis for many patients.

“The finding that the cure rate in the placebo group was higher than ever previously observed in a published placebo-controlled BV-trial was intriguing and led us to some interesting results. Consequently, we have filed a new patent application for the use of active substance contained in the placebo.”

Details of the clinical trial can be found at https://clinicaltrials.gov/ct2/show/NCT04640922 Further analysis of the data will follow including analysis of the vaginal microbiome (in cooperation with Karolinska Institutet) regarding presence of Candida and the effect on Lactobacilli and pathogenic bacteria.