· Important expansion of patent estate in the largest market for vaginal bacterial infections
· pHyph has shown superior safety profile, a cure rate in line with antibiotics and a lower infection recurrence rate
Lund, Sweden, April 18, 2023. Swedish women’s health company Gedea Biotech announced today that the United States Patent and Trademark Office (USPTO) has granted the company´s patent application 16/753,899 directed to gluconic acid derivatives for preventing and/or treating bacterial infections. The patent number is US 11,612,584 and the patent can be kept in force until 2038. The specific derivative Glucone-delta lactone (GDL) in pHyph™ is a well-documented substance with a low risk of developing antimicrobial resistance.
Gedea Biotech additionally holds granted patents within the same patent family in Singapore and Ukraine, as well as granted patents for treatment of fungal infections in USA, Japan, Europe, China, South Korea, Australia, Mexico, Ukraine, Israel, Chile, Hong Kong, South Africa and Singapore, and is in IPT-phase for a patent on formulation of the tablet.
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 present US-patent confers protection for treatment and prevention of bacterial vaginosis by GDL.
Annette Säfholm, Gedea Biotech’s CEO comments: “The US patent covering treatment and prevention of vaginal bacterial infections by GDL, or pHyph, strengthens Gedea’s position in one of the largest markets for treatment of these conditions. pHyph has the potential to replace a substantial share of the antimicrobials used for vaginal infections today.”
In two previous clinical studies, whereof the most recent being a placebo-controlled trial including 152 patients, conducted at several sites in the UK and Sweden,
Gedea Biotech has demonstrated good results for pHyph in treatment of bacterial vaginosis, with a cure rate in line with antibiotics on the market but with superior safety profile and lower recurrence rate.
For more information
For further information, please contact:
Annette Säfholm, CEO Gedea Biotech
Ton Berkien, Chairman, Gedea Biotech
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.