Gedea Biotech receives approval to initiate the pivotal NEFERTITI-2 clinical study documenting the performance of pHyph for treatment of bacterial vaginosis
- 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.
*Three Amsel criteria:
- Thin, white, yellow, homogeneous discharge
- Clue cells on microscopy (>20% of epithelial cells)
- Release of a “fishy odour”, i.e., a positive “whiff test” when alkali (10% potassium hydroxide [KOH] solution) is added.
For the clinical cure assessment, the fourth Amsel criterion, pH of vaginal fluid >4.5, has not to be fulfilled.
“Bacterial vaginosis is a very common vaginal infection caused by an overgrowth of unhealthy bacteria in the vagina and affecting 1-2 in every 10 women”, says Coordinating Investigator Aino Fianu Jonasson, MD, PhD and specialist in Urogynecology at the Womens Health Department, Karolinska University Hospital, Huddinge, Sweden. “While standard antibiotic treatments work well in the short term, there is a very high rate of recurrence and as antibiotic resistance grow, we should avoid prescribing antibiotics if there are alternatives. There is therefore a need for an effective antibiotic-free product which can treat BV and prevent recurrence”.
Annette Säfholm, Gedea Biotech’s CEO 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. This pivotal study constitutes a vital component to receive European approval for pHyph™ in treating and preventing bacterial vaginosis recurrence as well as to prepare for pivotal phase 3 US studies.”
For more information
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 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 action, 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 demonstrated 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.
