• This pivotal study aims to confirm the safety and efficacy of pHyph in treating and preventing BV recurrence
• Patient recruitment will now be initiated and 5 Swedish clinics are planned to attend
• Previous studies in BV have demonstrated pHyph to have a BV cure rate in line with antibiotics on the market, with superior safety profile and without causing the secondary candida infections and the high recurrence seen when treating BV with antibiotics

Lund, Sweden, November 8, 2023. Swedish women’s health company Gedea Biotech developing antibiotic-free treatments, today announced that the Swedish Medical Product Agency and Ethics committee have approved the initiation of a randomized, partly-blinded investigation to evaluate the clinical performance and safety of pHyph™ in adult women with bacterial vaginosis (BV) compared with an untreated control group. Recruitment of patients to the clinics is thereby initiated.

Recurring vaginal infections affect at least 400 million women annually around the world and can be caused by either bacteria or fungi, although bacterial vaginosis is the most common vaginal infection in women of reproductive age. The severity varies from mild to complicated and can lead to more severe conditions such as deep infections in the pelvis and increased risk of pre-term birth. It is often recurring, especially after antibiotic treatments, requiring repeated medication.

The clinical trial is a randomized, parallel group, partly blinded study that will be conducted at 5 Swedish sites in a cohort of up to 92 adult women with confirmed bacterial vaginosis. Patients will be randomised to active treatment with pHyph™ or to a control-group without treatment, in a 1:1 ratio. The Investigators carrying out the gynaecological assessments will be blinded. The primary endpoint of the study is clinical cure rate, defined as the absence of 3 Amsel criteria (see below*) at day 7. Patients in the control-group, not cured day 7, will receive pHyph™ treatment according to the same scheme as the initial active treatment group. The patients cured day 25 after initiated treatment will be receiving a twice weekly pHyph™ treatment for an additional 45 days to assess BV recurrence prevention and effects on the vaginal microbiome. In the study, subjectively reported symptoms, as well as safety and local tolerability for patients receiving the preventive treatment will also be investigated.

An interim analysis will be undertaken after 62-66 patients have been included and if the primary endpoint, clinical cure rate on day 7, defined as the absence of 3 Amsel criteria (see below*), shows statistical significance, patient inclusion will be terminated.

Reference: Click Here