Gedea Biotech 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, reports the company. Final results of the trial are expected to be ready by the end of the year.
“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,” says Annette Säfholm, Gedea Biotech’s CEO.
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.
Photo of Annette Säfholm: Gedea Biotech