Follow-up study of Microbiome samples now underway at Karolinska to provide further insights
Lund, December 16, 2020: Gedea Biotech today announced that results from a recently published study show that their pHyph antibiotic-free treatment for bacterial vaginosis has a high cure rate and prevents recurrence of the infection.
Titled “A novel non-antimicrobial treatment of bacterial vaginosis: An open label two-private centre study” the results were published in peer-reviewed European Journal of Obstetrics & Gynaecology and Reproductive Biology. The clinical trial was run by Lund University Hospital, Sweden and the analysis of the data and the scientific writing has been done in collaboration with a research group at Nottingham University Hospital.
Taking advantage of new research technologies, follow-up investigation at the Karolinska Intitutet is now underway of microbiome samples collected during the study. This is expected to reveal additional insights into patient responses.
Bacterial vaginosis (BV) is the most common cause of vaginal discharge in women, characterized by a dysbiosis or microbial imbalance of the vaginal microbiota. Signs and symptoms include an often profuse thin, white, “fishy” smelling vaginal discharge, in the absence of itching. Standard treatment consists of oral or topical vaginal antimicrobials, with cure rates of 80–90 % at 1 week, but recurrence rates of 15–30 % within 3 months. This results in women requiring repeated treatments, with a risk of developing antimicrobial resistance, and of disturbing the normal vaginal microbiota further. Antimicrobial resistance is one of the World Health Organization’s top ten threats to global health in 2019 and research into novel non-antimicrobial based treatments is timely.
The aim of this study was to investigate the clinical performance of pHyph, a new natural product-based treatment developed by Gedea, in an open label study for BV treatment and prevention of its recurrence.
Participants were adult women with confirmed BV according to fulfilment of at least three of the four Amsel’s criteria*. The primary outcome from the study was cure; defined as absence of the three, non-pH related Amsel criteria This is the most used and accepted definition of clinical cure for bacterial vaginosis.
28 patients were screened, 24 enrolled and treated. There were two withdrawals before data collection which leaves 22 patients who completed 7 days of treatment. Seven of the 22 patients suffered from recurrent BV defined as three or more infections in the past year. Women with recurrent BV had a higher cure rate of 86 % (6/7) than women with less than three episodes of BV in the past year.
This study has shown this novel BV treatment gives high short-term cures rates of 82 % (n = 18/22) at day 7, and low rates of recurrence at 14 days of 5.6 % (n = 1/18), with no additional recurrences reported at 35 days. The early cure rate is comparable with standard treatment cure rates of 80–90% at 7 days. Recurrence appears to be lower than standard of care at 5.6 % at one month compared to 15–30 % with standard of care at 3 months.
Dr Harriett Latham-Cork, Nottingham University, lead author of the study commented:
“The results are extremely promising and point towards this new treatment providing an effective alternative to current antibiotics. Of course,this would in turn contribute to fighting antibiotic resistance.”
Annette Säfholm CEO of Gedea Biotech added:
“Encouraged by these results we are now running a larger placebo-controlled, double-blind study with 150 patients in UK and Sweden and expect topline results in late 2021. In addition, we are taking advantage of exciting new advances in microbiome diagnostics to analyse samples from the study at the Karolinska Institutet in Stockholm.”
The clinical study included microbiome samples at day 0, 7 and 35 and they are being analysed by Karolinska Institutet:
Centre for Translational Microbiome Research (CTMR).
“The microbiome samples from this clinical trial add new data to the field of microbiome research,” says Ina Schuppe at KI. “At KI, we can make a comparison between the microbiomes from these patients with BV with microbiomes from healthy women. It will probably provide us with information about how the treatment impacts the microbiome and also the role of the microbiome in treating and preventing bacterial vaginosis.”
* Amsel criteria: Vaginal discharge, Clue cells, Fishy odour, pH above 4.5