Gedea Biotech has added three Swedish clinics to its NEFERTITI clinical study of its lead product, pHyph, a vaginal tablet for topical treatment of bacterial vaginosis (BV).
The randomized double-blind placebo-controlled study is designed to confirm safety and efficacy of pHyph. The NEFERTITI study is financed by the EU program Horizon 2020 and run by the consortium partners Nottingham University NHS Hospitals Trust, LINK Medical and Gedea Biotech.
The Swedish clinics that will be a part of the study is located in Stockholm, Malmö and Helsingborg. 150 persons will be included in the study. A previous, smaller study, has shown that pHyph had as good treatment effect as antibiotic for bacterial vaginosis.
Bacterial vaginosis is a type of vaginal inflammation caused by the overgrowth of bacteria naturally found in the vagina, which upsets the natural balance. Women in their reproductive years are most likely to get bacterial vaginosis, but it can affect women of any age.
“Patients with bacterial vaginosis often receive antibiotic treatment and in 80 to 90 percent of the cases the infection is cured within a week,” says Catharina Hofte, gynecologist at the Hofte clinic in Helsingborg. “The treatment is usually effective but it is common with reoccurring infections. There is a need for more easily available treatment alternatives for bacterial vaginosis and therefore, this study is important.”
The primary objective is to investigate clinical performance of pHyph. After the first treatment period (day 0-7), patients that are cured (a high cure rate is expected based on a previous smaller study), will be randomized to preventive treatment, and given one tablet a week of pHyph or placebo, for four months. The follow up period will provide important data on pHyph’s impact on prevention of recurrent infections and the effect on the vaginal microbiome.
“In a smaller study reported last year 82% of the women were clinically cured, defined as absence of all Amsel criteria, after 7 days on pHyph treatment, thus corresponding to the outcome of existing antibiotic-based treatment. This larger trial will be pivotal in confirming that pHyph can provide an effective and long-lasting treatment alternative to antibiotics,” says Annette Säfholm, Gedea Biotech’s CEO.
Photo of Annette Säfholm