Lund, Sweden, February 08, 2022. Swedish women’s health company Gedea Biotech today announced that despite the COVID-19 pandemic it has successfully completed recruitment 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 across 6 UK and 4 Swedish sites. Results from the first treatment period (day 0-7) are expected in Q2 and for the follow-up period in Q3. This would put the company in a strong position to achieve CE-marking by the end of the year.
Bacterial vaginosis is the most common vaginal infection and affects around 10-30% of women of reproductive age. It is a bacterial condition in 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.
“I am proud and delighted that despite the pandemic, the team have managed to complete recruitment to this important trial, it's all down to their tremendous hard work” says Dr Kate Walker, Clinical Associate Professor in Obstetrics, University of Nottingham and chief 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 cures bacterial vaginosis and prevents recurrence would therefore be a major step forward for women. I'd like to say a massive thank you to all the women who took part in the trial”
Annette Säfholm, Gedea Biotech’s CEO comments: “Thanks to the great efforts through this difficult period of the team, Link Medical and all the clinical sites, we have succeeded in reaching this major milestone. We believe the NEFERTITI study will confirm the previous positive results of pHyph in the treatment of bacterial vaginosis and deliver an evaluation of the long-term effect of pHyph. If positive this will enable us to aim for CE-marking by the end of the year and start commercialisation.”
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
About the NEFERTITI study
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, 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.
*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.
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 vaginal tablet, pHyph acts 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 research at Nottingham University Hospitals NHS Trust
Nottingham University Hospitals NHS Trust is one of the biggest and busiest acute hospitals in England, employing over 16,000 staff. We provide care to over 2.5million residents of Nottingham and its surrounding communities and specialist services to a further 3-4million people from neighboring counties. We are one of the most research-active Trusts in the country with world-leading clinical research delivered across our hospitals through over 400 clinical trials a year. Our NIHR Nottingham Biomedical Research Centre is translating research discoveries into new treatments for common diseases including asthma and arthritis. Central to our research is our expertise in Magnetic Resonance Imaging (MRI). Supporting this is the NIHR Nottingham Clinical Research Facility which provides the infrastructure, skills and knowledge essential to the delivery of high-quality research into experimental medicine for adults and children.
About LINK MedicalLINK Medical is a full-service contract research organization (CRO) providing product development services for the pharmaceutical and medical device industries across Northern Europe. We offer a well-integrated local presence in all Nordic countries, UK, and Germany. Reaching from early phase development to post-marketing, we have over 190 employees providing expert guidance across every aspect of a project – all from ONE source. Our promise is to improve and accelerate your product development through transformative methods, active communication, and optimal solutions. As a strategic partner, we provide expert competence and technology to enable evidence-based decision-making that supports the delivery of superior clinical outcomes.