Gedea Biotech initiates EpHect Clinical Trial for Antibiotic-free Treatment of Women with Vulvo Vaginal Candidiasis
- Up to 75% of all women are affected by vaginal infection in their lifes
- Self-diagnoses leads often to unnecessary and inappropriate treatment use
- This study aims to confirm the safety and efficacy of pHyph in VVC
Lund, Sweden, May 2, 2023. Gedea Biotech today announces that the treatment of the first patients with its lead product, pHyph, a vaginal tablet for topical treatment, has begun. The open-labelled study is designed to confirm the safety and efficacy of pHyph in treating adult women with confirmed Vulvo Vaginal Candidiasis (VVC) and in restoring a beneficial vaginal microbiome to prevent recurrence of the infection. The study is being conducted at four Swedish gynecological clinics.
Vaginal infection is a huge and largely underestimated problem, affecting 70% to 75% of women at some point in their life. 5% to 8% of adult women have recurrent vulvovaginal candidiasis (VVC) with at least 4 episodes each year. Many women self-diagnose VVC and purchase anti-fungal treatments, but their diagnosis is often incorrect, and the treatment is therefore unnecessary or inappropriate. As symptoms will frequently be due to a bacterial vaginosis (BV) infection or mixed VVC and BV infection, a product capable of treating both VVC and BV would be a particularly attractive remedy.
Annette Säfholm, CEO of Gedea Biotech comments: “In previous studies, pHyph has shown a good effect in treating BV in line with antibiotics on the market, but with superior safety profile and without causing the secondary candida infections and the high recurrence seen when treating BV with antibiotics. pHyph has furthermore in previous clinical studies been shown to restore the beneficial vaginal microbiome, important also for treating and preventing vaginal candida infections. The aim of this study is to confirm the safety and efficacy of pHyph in treating VVC. A product with dual effect in treating bacterial vaginosis and vaginal candidiasis would be an ideal treatment for the large group of women who are uncertain of which type of infection that causes their symptoms”.
"Vaginal Candida infection, or vaginal yeast infection, is a common concern for women," says Helena Kopp Kallner, chief physician at Danderyd Hospital Clinical Sciences Obstetrics and Gynecology and principal investigator in the study. “A fungal infection can, for example, be caused by antibiotic treatment for urinary tract infections or throat infections. An antibiotic treatment also kills the protective bacteria that counteract other infections and fungi and allows the fungus to establish itself. Today, fungi are treated with so-called antifungal drugs that can lead to the development of resistance. Since the fungal problem often returns, women often need repeated treatments. Hence, there is therefore a need for an effective product which can prevent the problem with returning fungal infections or a product void of antifungals which can be applied several times such as Gedea's product.”
For further information, please contact:
Annette Säfholm, CEO Gedea Biotech
Telephone: +46 708 - 91 86 81
Email: annette.safholm@gedeabiotech.com
Ton Berkien, Chairman Gedea Biotech
Telephone: +46 70- 791 49 54
Email: ton.berkien@gedeabiotech.com
About Vulvo Vaginal Candidiasis
Several factors can contribute to VVC
- Changes in vaginal microflora composition increase the pH, which in turn forms a favorable environment for vaginal pathogens
- Vaginal or systemic antibiotic treatment against bacterial vaginosis is frequently followed by VVC, likely due to the elimination of the protective bacterial flora, thereby allowing Candida overgrowth
- Infections are also facilitated by the mucosal effect of increased estrogen levels and a weakened immune system, e.g., during pregnancy
- Recurrent infections are more common in pregnant women, and their response to therapeutic treatment is reduced compared to non-pregnant women.
- Contraceptive pills, menstruation, and diabetes mellitus have been identified as predisposing factors for VVC
About the clinical trial (Clinical Performance of the Gedea Pessary in Adult Women With Vulvovaginal Candidiasis (EpHect))
- In this study, 26 post-menarchal, pre-menopausal, 18 years or older, seeking care for VVC symptomatic female patients, with a VVC diagnosis will be treated for 6 days (Day 0 to Day 5) and undergo follow-up visits until Day 25. For more information, see https://clinicaltrials.gov/ct2/show/NCT05507333?spons=Gedea+Biotech&draw=2&rank=1
About pHyph
The vaginal tablet, pHyph will treat bacterial vaginosis (BV) and prevent recurrence by promoting a healthy vaginal microbiome, restoring the vaginal pH to its normal level of pH 4,0 - 4,5 and by breaking down the biofilm formed during BV under which the infectious bacteria begin to thrive. These mechanisms of actions, together provide a beneficial environment for the healthy vaginal microbiome. The naturally occurring active ingredient GDA 001 in pHyph is well documented and is already approved as a food additive. A clinical cure rate for BV on par with antibiotics on the market, has been proven in two phase 2 trials, with a superior safety profile and without causing secondary VVC infections as antibiotics do.
About Gedea Biotech
Gedea Biotech is a Swedish, innovative women’s health company developing pHyph, the first antibiotic free treatment that both prevents and treats bacterial vaginosis. Vaginal infections affect at least 400 million women every year worldwide and the market is worth over $ 1.5 billion. Gedea Biotech was founded in 2015 in Lund, Sweden.
