Gedea Biotech reports 82 % clinically cured in antibiotic-free treatment trial in women with bacterial vaginosis
Lund, Sweden, March 11, 2020. Gedea Biotech, an innovative women’s health company today reported results from a clinical study of its lead product, pHyph, a vaginal tablet for topical treatment of bacterial vaginosis (BV). In this open-label, single-armed, multi-center study, 82% of the women were clinically cured after 7 days. The cure rate corresponds to existing antibiotic-based treatment. Bacterial vaginosis (BV) is the most common vaginal infection with a prevalence of 10–29% in the whole female population and rising up to 50% in pregnant women (1,2,3).
The symptoms of BV include a vaginal discharge, a fishy odour and sometimes a burning pain. It can affect and limit many aspects of daily life. Gedea wishes to caution however, that whilst these results are highly promising, further studies are needed to confirm results. Larger studies including recurrence data are being planned.
The vaginal tablet, pHyph acts by restoring the patient’s pH to its normal level of pH 4,0 - 4,5 which is optimal for the protective lactobacilli pHyph also breaks down the biofilm formed during bacterial vaginosis in which the infectious bacteria begin to thrive. The naturally occurring active ingredient GDA 001 in pHyph has a well-documented safety profile and is already approved as a food additive.
The pHyph study* enrolled a total of 24 patients each of whom met at least three of the four Amsel criteria – a thin white yellow homogeneous discharge; clue cells on microscopy; a pH of vaginal fluid > 4.5 and release of a fishy odour on adding alkali. Patients were treated with pHyph for one week and primary endpoints were the clinical cure rate at Day 7 as well as safety and tolerability data. Patients were aged 18-49 and the median age was 33. In the Full Analysis Set (FAS, n=22) a total of 18 women (82%) were clinically cured, as defined by the absence of all the three Amsel criteria. Recurrence numbers at day 35 were found to be very low. The full result will be presented at the European Spontanous Preterm Birth Congress I Haarlem, Netherlands, May 13-15 this year.
“Bacterial vaginosis is a common problem, and current remedies such as antibiotics are not always effective. There is 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 Skåne University Hospital, Lund. Dr. Monika Cardell was also the Principal Investigator of the clinical trial.
Annette Säfholm, Gedea Biotech’s CEO comments:
“These results for pHyph are indeed highly promising, showing effectiveness equivalent to antibiotics in treating bacterial vaginosis. The cure rate and recurrence numbers gives us strong confidence to continue our pHyph program and to confirm the results in upcoming studies.”
*Details of the clinical trial can be found at https://www.clinicaltrials.gov/ct2/show/NCT03762083?cond=Bacterial+Vaginosis&cntry=SE&rank=1
For further information, please contact:
Annette Säfholm, CEO Gedea Biotech
Telephone: +46 708 - 91 86 81
Olov Sterner, Chairman Gedea Biotech
Telephone: +46 705- 30 66 49
About Gedea Biotech: Gedea Biotech develops an antibiotic-free treatment for vaginal bacterial infections; bacterial vaginosis (BV). pHyph intends be the first antibiotic-free product that effectively treats bacterial vaginosis and prevents recurrence. Today, BV is treated with antibiotics and one out of two patients have a recurrent episode of BV within 90 days after treatment. A significant number of patients also get an antibiotic induced vaginal fungal infection. WHO see antibiotic resistance as one of the largest threats to global health. When antibiotics are present, antibiotic resistance will occur, sooner or later. Gedea aim to contribute to a better world where antibiotics are never used unnecessarily and we will do what we can to combat microbial resistance. pHyph aims to be a first line treatment, sold over the counter (OTC) in pharmacies, available when women need it. Gedea received a grant of €3M from Horizon in 2019 and has delivered on every target since the start in 2015 in Lund, Sweden. www.gedeabiotech.com
Gedea Biotech is Alumni to SmiLe Incubator, a business incubator that supports startups, is specialized in life science and based at Medicon Village in Lund. www.smileincubator.life