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Gedea Biotech to Start EpHect Clinical Trial

Annette Säfholm

Gedea Biotech 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.

“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.”

“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,” says Annette Säfholm, CEO of Gedea Biotech.

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.

Photo of Annette Säfholm: Gedea Biotech