Gedea Biotech has reported top-line results from a clinical study, NEFERTITI, of its lead product, pHyph, a vaginal tablet for topical treatment of bacterial vaginosis (BV).
NEFERTITI is a placebo-controlled, double blind clinical trial performed in Sweden and UK in 150 patients.
Treatment details
The treatment is a vaginal tablet taken once daily for six days at home. Already on the first day after pHyph treatment, a pronounced reduction of fishy smell, which is the most disturbing symptom of BV was observed, and after treatment, 70% of patients were completely free of the symptom and 90% of patients experienced alleviation.
pHyph treatment resulted in a 50.4% cure rate after six days. 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 that led to a new patent filing.
Also, pHyph treatment showed a considerably lower recurrence rate compared to placebo, though not statistically significant, both at day 35 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 one patient was diagnosed in the placebo group and at least three patients among those 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 to initiate phase 3 trials for subsequent FDA approval in the U.S.
About bacterial vaginosis
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 bacteria, 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 odor and sometimes a burning pain.
The condition is treated with antibiotics and/or antiseptic treatment products but recurring bacterial vaginosis is common and treatment with antibiotics often induce vulvovaginal candidiasis. Approximately 8 million prescriptions of antibiotics are currently issued each year for BV in the U.S. and in the EU combined.
Antibiotic resistance
“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,” said Helena Strevens, senior consultant, associate professor, Dept of Obstetrics and Gynecology, Skåne University Hospital.
“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.”
Several advantages
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.”
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.