US-patent for Swedish bacterial vaginosis therapy


The United States Patent and Trademark Office (USPTO) has granted Gedea Biotech’s patent application 16/753,899 directed to gluconic acid derivatives for preventing and/or treating bacterial infections.

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.

Annette Säfholm, Gedea Biotech’s CEO, commented: “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, pHyph in the treatment of bacterial vaginosis has demonstrated a cure rate in line with antibiotics on the market but with superior safety profile and lower recurrence rate.

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