Half way into Gedea Biotech’s NEFERTITI clinical trial of pHyph   antibiotic-free treatment of bacterial vaginosis 

Lund, Sweden, September 8, 2021, 2021. Swedish women’s health company Gedea Biotech today announced that it has enrolled more than 50% of patients in the 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 the safety and efficacy of pHyph and is coordinated by Nottingham University NHS Hospitals Trust in the UK.

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

“The team of investigators are putting tremendous effort into recruiting patients, and I am delighted to see the progress we are making,” says Dr Kate Walker, Clinical Associate Professor in Obstetrics, University of Nottingham and principal investigator for the study. “We have standard antibiotic treatments for bacterial vaginosis which work well in the short term, but there is a very high rate of recurrence. This results in women having to take multiple courses of antibiotics which contributes to the global problem of antibiotic resistance. A non-antibiotic treatment that prevents recurrence would therefore be a major step forward.”

Annette Säfholm, Gedea Biotech’s CEO comments: “We are conducting the NEFERTITI study to confirm the previous positive results of pHyph in the treatment of bacterial vaginosis and to evaluate the long-term effect of pHyph. Thanks to superb efforts by investigators in Sweden and England, we have come halfway into the study, despite the very difficult conditions for recruiting patients for studies right now.”