Lund, Sweden, March 27, 2025

Gedea Biotech announced today that the United States Patent and Trademark Office (USPTO) has granted the company’s patent application covering the active ingredient in the company’s first product, pHyph, to prevent preterm birth (premature delivery) in pregnant women with bacterial vaginosis.

The recently approved patent protects “a method for preventing preterm birth in a pregnant individual with bacterial vaginosis.” This method aims to prevent preterm birth in individuals with bacterial vaginosis during pregnancy. Additionally, two US patents have already been approved for the treatment of fungal infections using GDA 001, the active ingredient in Gedea’s pHyph product, as well as a patent covering the treatment of bacterial infections and bacterial vaginosis with GDA 001.

Currently, there is a lack of effective treatments that reduce the risk of preterm birth, and such a treatment would have a tremendous impact on obstetric and neonatal care worldwide. Approximately one in ten children is born prematurely (before 37 weeks gestation), and in 2020, 13.4 million babies were born prematurely worldwide. The healthcare costs associated with preterm birth are estimated at USD 25 billion, just in the United States.

Helena Strevens, MD, Ph.D, Medical Director at Gedea Biotech explains the perilous association between bacterial vaginosis and preterm birth:

  • It is well known that bacterial vaginosis, and other imbalances in the bacteria present in the vagina, increase the risk of preterm birth. If a pregnant woman’s vaginal microbiome is dominated by lactobacilli, she has a greater chance of reaching term. pHyph has in recent studies been shown to significantly improve the vaginal microbiome, specifically through increasing the presence of beneficial lactobacilli and decreasing vaginal dysbiosis, says Helena Strevens.

Further studies on preventing preterm birth with pHyph may be conducted through collaborations or partnerships with pharmaceutical companies active in this area.

Gedea Biotech holds granted patents in the same patent family in Europe, China, and Japan, as well as granted patents for the treatment of fungal infections in the US, Japan, Europe, and China. Additionally, Gedea Biotech holds granted product patents for pHyph in Europe, China, India, and Japan.

Annette Säfholm, CEO of Gedea Biotech, comments:

  • The US patent covering a method to prevent preterm birth with pHyph strengthens Gedea’s opportunities in one of the largest markets. The results we have today regarding the microbiome are promising, and further studies will provide deeper insights into preterm birth, says Annette Säfholm.