Gedea Biotech has enrolled the first patient 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 safety and efficacy of pHyph and is coordinated by Nottingham University NHS Hospitals Trust in the UK. 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.
NEFERTITI aims to recruit 150 adult women aged 18 or over with bacterial vaginosis diagnosed by Amsel’s criteria. 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. Patients in the UK and in Sweden will be enrolled in the NEFERTITI study.
“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.
LINK Medical– a strategic partner
The randomized double-blind placebo-controlled study is designed to confirm safety and efficacy of pHyph and is coordinated by Nottingham University NHS Hospitals Trust in the UK and LINK Medical.
“LINK Medical is proud to be a strategic partner, supporting Gedea in improving their strategy which has helped with the planning of their clinical trials as well as to get funding from the EU program Fast Track to Innovation (FTI), part of Horizon 2020. Today we celebrate reaching another very important milestone after a year overcoming challenges with Covid-19. With 4 sites in the UK and 3 sites in Sweden we are ready to get this clinical trial running with a great team. We are looking forward to positive results in this transformational treatment for women,” says Ola Gudmundsen.
Photo of Annette Säfholm: Gedea Biotech