- Symptom reduction was seen in 90% of patients and absence of symptoms was noted in 70% of patients
- Clinical cure rate was 50,4% in the pHyph group, which is in line with many antibiotic treatments on the market
- The rate of recurrence of BV was substantially lower at day 35 with pHyph, 13.9%, compared to placebo, 27%, and throughout the 4 months1
Lund, Sweden, October 11th, 2022. Gedea Biotech, an innovative women’s health company today 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. 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, 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 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 throughout the four-month study period1. Further analysis on occurrence of vaginal dysbiosis are 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.
1 Errata re. data on recurrence after antibiotic rescue treatment was not consistently reported and needs to be reanalyzed. The full data set will be published as a scientific article. Rescue treatment was given to patients who were not responding to the treatment with pHyph or placebo.
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 odour 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 US and in the EU combined.
“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.” says Dr. Helena Strevens, MD, PhD, Senior Consultant, Associate Professor . Dep of Obstetrics and Gynecology, Skåne University Hospital.
Annette Säfholm, Gedea Biotech’s CEO comments:
“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.
For further information, please contact:
Annette Säfholm, CEO Gedea Biotech
Telephone: +46 708 - 91 86 81
Ton Berkien, Chairman Gedea Biotech
Telephone: +46 70- 791 49 54
The vaginal tablet, pHyph acts through restoring the vaginal pH to its normal level of pH 4,0 - 4,5 and by breaking down the biofilm formed during bacterial vaginosis under which the infectious bacteria begin to thrive. The naturally occurring active ingredient GDA 001 in pHyph is well documented and is already approved as a food additive.
About Gedea Biotech
Gedea Biotech is a Swedish, innovative women’s health company developing pHyph, the first antibiotic free treatment that both prevents and treats bacterial vaginosis. Vaginal infections affect at least 400 million women every year worldwide and the market is worth over $ 1.5 billion. Gedea Biotech was founded in 2015 in Lund, Sweden.
About the NEFERTITI study
The NEFERTITI study is now fully recruited with 150 patients in Great Britain and Sweden. The primary objective is to investigate clinical performance of pHyph for bacterial vaginosis. pHyph is a vaginal tablet and treatment schedule was 1 tablet a day for 6 consecutive days. Patients who were cured after the first treatment period were monitored for 4 months and given a preventive treatment with 1 tablet per week (placebo or pHyph). https://clinicaltrials.gov/ct2/show/NCT04640922