Gedea Biotech, an innovative women’s health company, today reports that all 24 patients have been treated with its lead product, pHyph, a vaginal tablet for topical treatment of bacterial vaginosis in a proof of concept clinical study. In this open-label, single-armed, multi-center study, promising results have been seen when it comes to clinical performance, tolerability, and safety. Final results of the trial are expected to be ready by the end of the year.
The vaginal tablet, pHyph acts by breaking down the biofilm formed during bacterial vaginosis under which the infectious bacteria begin to thrive. This restores the patient’s pH to its normal level of pH 4,0 - 4,5. The naturally occurring active ingredient GDA 001 in pHyph is well documented and is already approved as a food additive.
“Bacterial vaginosis is a common problem, and current remedies such as antibiotics are not always effective. There is a need for new, effective treatments not involving antibiotics. The results of this study are promising and may lead to a much-needed treatment alternative”, says Dr. Monika Cardell, MD and senior consultant in obstetrics and gynecology at Lund University Hospital. Dr. Monika Cardell is also the Principal Investigator of the clinical trial.
Annette Säfholm, Gedea Biotech’s CEO comments: “We are delighted to report that we already see promising results when it comes to efficacy of this treatment for which we have a use patent, of bacterial vaginosis intended to be curative. Furthermore, tolerability and safety were both excellent. We now look forward to analyzing and reporting the results later this year.”
Details of the clinical trial involving 24 patients at two sites in Sweden can be found at www.clinicaltrials.gov
For further information, please contact:
Annette Säfholm, CEO Gedea Biotech
Telephone: +46 708 - 91 86 81
About bacterial vaginosis
Bacterial vaginosis is the most common vaginal infection in women of reproductive age and is a disease of the vagina caused by excessive growth of bacteria producing an imbalance of the naturally occurring bacteria in the vagina. The condition is treated with antibiotics and/or antiseptic treatment products. Recurring bacterial vaginosis is common.
About Gedea Biotech
Gedea Biotech is a Swedish, innovative women’s health company developing pHyph, an antibiotic free and effective treatment of bacterial vaginosis. Vaginal infections affect at least 400 million women every year worldwide and the market is worth over $ 1.5 billion. In addition to developing a treatment of bacterial vaginosis, Gedea Biotech is currently also pursuing a clinical trial with pHyph in patients suffering from fungal vaginal infection. Gedea Biotech was founded in 2015 in Lund, Sweden.