Gedea Biotech receives MHRA approval to initiate NEFERTITI Clinical Trial in the UK of pHyph for antibiotic-free treatment of women with bacterial vaginosis
Lund, Sweden, October 27, 2020. Gedea Biotech,today announces that it has received approval from the UK Medicines and Healthcare Products Regulatory Agency (MHRA) to proceed with 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 safety and efficacy of pHyph and will be coordinated by Nottingham University NHS Hospitals Trust in the UK.
Bacterial vaginosis is a vaginal infection with a prevalence of 10-30% in adult women. The infection causes disturbing symptoms that affects daily life in many ways. NEFERTITI aims to recruit 150 adult women aged 18 or over with bacterial vaginosis diagnosed by Amsel’s* criteria and is due to start in October 2020. The primary objective is to investigate clinical performance of pHyph – in a smaller study reported earlier this year 82% of the women were clinically cured, defined as absence of all Amsel criteria, after 7 days. This corresponds to existing antibiotic-based treatment. After the first treatment period (day 0-7), patients that are cured 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 microbiome.
“I am delighted to lead the NEFERTITI study as the Chief Investigator,” commented Dr Kate Walker, Clinical Associate Professor in Obstetrics, University of Nottingham. “Bacterial vaginosis is a very common vaginal infection, affecting 1-2 in every 10 women, caused by an overgrowth of unhealthy bacteria in the vagina. We have standard antibiotic treatments which work really 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 bacteria becoming resistant to antibiotics. It would be a major step forward to have a non antibiotic treatment that cures women and prevents recurrence. That's why I'm so excited about the NEFERTITI trial as we may have found such a new treatment. It's really important to do the study properly and check the treatment is effective and acceptable to women.”
Annette Säfholm, Gedea Biotech’s CEO comments: “This larger trial will be pivotal in demonstrating that pHyph can provide an effective and longlasting treatment alternative to antibiotics.”
*Diagnose of bacterial vaginosis according to Amsel criteria is at least three of the following criteria – thin white homogeneous discharge, clue cells on microscopy, pH of vaginal fluid above 4.5. and release of a “fishy” odor