· The study aims to confirm the safety and efficacy of pHyph in the treatment of vaginal yeast infection (VVC).
· The study includes 26 patients, all of whom have now commenced treatment with pHyph.
· Results from the study are expected in the second quarter of 2024.
Lund, Sweden, February 8, 2024
The Swedish femtech company Gedea Biotech, which is developing an antibiotic-free treatment for vaginal infections, today announced that all patients in the EpHect study have been included and commenced treatment with pHyph. Results from the study are expected in the second quarter of this year.
Vaginal yeast infection affects 75% of all women at some point in their lives. Treatment is usually an over-the-counter cream or suppositories, and if symptoms are severe or recurrent, prescription per oral treatment is available. Globally, there are signs of and concerns about resistance developing against available treatments. Self-diagnose is difficult and studies show that a majority of women who purchase over-the-counter products for the treatment of vaginal yeast infection do not actually have a yeast infection. This leads to over-treatment and the risk of resistance developing.
The EpHect study has been conducted at four clinics in Sweden, with a total of 26 patients participating. Patients have been treated with pHyph for six days using vaginal tablets at home. After the treatment period, patients were followed up for 25 days to evaluate treatment effectiveness and whether the infection recurs. The clinics have used internationally applicable criteria for diagnosis and evaluation.
"Vaginal fungal infection is very common, and some women suffer from prolonged, recurrent symptoms. The drugs available usually work well, but relapses are common, and there is concern about resistance developing in the future. More treatment options are needed for this patient group," says Helena Kopp-Kallner, Chief Physician in Gynecology, Ph.D., at the Women's Health Clinic at Danderyd Hospital, Stockholm, Sweden, who is the responsible physician for the EpHect study.
Annette Säfholm, CEO of Gedea Biotech, comments:
"The clinics that have participated in the study have done a fantastic job of including patients and conducting the study. We are also extremely grateful to the patients who have participated and contributed to important research. The purpose of the EpHect study is to confirm the safety and efficacy of pHyph in the treatment of vaginal yeast infection. A product with dual effect in the treatment of bacterial vaginosis and yeast infections would be an ideal treatment for all the women who are unsure of the type of infection causing their symptoms."
The EpHect study is supported by Swelife and MedTech 4 Health.
For more information
For further information, please contact:
Annette Säfholm, CEO Gedea Biotech
Phone: +46 708 - 91 86 81
Email: This email address is being protected from spambots. You need JavaScript enabled to view it.
Ton Berkien, Chairman of the Board, Gedea Biotech
Phone: +46 70- 791 49 54
Email: This email address is being protected from spambots. You need JavaScript enabled to view it.
About the EpHect study
An open-labelled study to evaluate Clinical Performance of the Gedea Pessary (pHyph) in Adult Women with Vulvovaginal Candidiasis:
26 women of menstruating age over 18 years with a VVC diagnosis are treated for 6 days (day 0 to day 5) and undergo follow-up visits until day 25. More information about the study can be found here: https://clinicaltrials.gov/ct2/show/NCT05507333?spons=Gedea+Biotech&draw=2&rank=1
About pHyph
pHyph is being developed as a vaginal tablet to treat and prevent both vaginal yeast infection and bacterial vaginosis. pHyph has no antimicrobial properties but affects the vaginal environment by lowering pH and dissolving biofilm so that the presence of yeast and bacteria develops in a healthy manner. With the dual effect against both yeast and bacterial infection, the chance of correct self-care increases, leading to reduced use of antimicrobial products and thus reduced resistance development. The naturally occurring active ingredient GDA 001 in pHyph is well-documented and is already approved as a food additive. A clinical healing rate for BV comparable to antibiotics on the market has been shown in two phase 2 studies but with a higher safety profile and without causing secondary VVC infections that occur with antibiotics.
Medtech4Health
Medtech4Health strive to increase the number and quality of new innovative products and services within medtech. In collaboration with patients, healthcare, academia, and business, we contribute to increasing value for people affected by disease in their everyday lives. Medtech4Health is funded by the Swedish government through the Swedish innovation authority Vinnova, Swedish Energy Agency and Swedish Research Council for Sustainable Development Formas, and by the programme’s partners.
www.medtech4health.se
Swelife
Swelife – For a competitive life science ecosystem in Sweden
Swelife is a strategic innovation programme, funded by the Swedish Government via the Swedish innovation authority Vinnova, Swedish Energy Agency and Swedish Research Council for Sustainable Development Formas, and by the programme’s partners, and by the programme’s partners. We support collaboration within academia, industry, and healthcare, with the goal to strengthen Life Science in Sweden and to improve public health.
www.swelife.se.
