Gedea Biotech today announces that it has received regulatory approval from the Ethics Committee and the Swedish Medical Products Agency and will start the EpHect clinical study of its lead product, pHyph, a vaginal tablet for topical treatment. 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 will be conducted at four Swedish clinics and at a clinic in United Kingdom.
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. The vaginal microbiome is a dynamic system, composed of a complex mixture of microorganisms in different ratios and quantities, which depend on lactic acid produced by healthy Lactobacillus species to maintain a weakly acidic environment.
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
There is a need for novel antibiotic-free treatment alternatives which are safe during pregnancy and have low risk for resistance development. 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.
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. Patients with known or apparent signs of other infectious causes of VVC and patients who were treated for VVC within the past 14 days or are currently receiving anti-fungal therapy unrelated to VVC will be excluded from the study.
Annette Säfholm, CEO of Gedea Biotech comments: “The start of the study is an important milestone for Gedea. pHyph has shown excellent effects in treating bacterial vaginosis and restoring a beneficial vaginal microbiome in previous clinical studies. The aim of this study is to confirm the safety and efficacy of pHyph in treating vulvovaginal candidiasis (VVC). A product with dual effect in treating bacterial vaginosis and vaginal candidiasis would be an ideal treatment for the large group of women which 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. 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 me as a doctor and researcher, I welcome that companies choose to carry out studies of good quality to be able to demonstrate the effect of their products. Such studies are important for us as doctors to enable us to recommend the product to our patients and to the general public”.
For further information, please contact:
Annette Säfholm, CEO Gedea Biotech
Telephone: +46 708 - 91 86 81
Ton Berkien, Chairman Gedea Biotech
Telephone: +46 70- 791 49 54
The vaginal tablet, pHyph acts restoring the vaginal pH to its normal level of pH 4,0 - 4,5 and by breaking down the biofilm formed during bacterial vaginosis under which the infectious bacteria begin to thrive. The naturally occurring active ingredient GDA 001 in pHyph is well documented and is already approved as a food additive.
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.