Ons 22 maj / År 42 / Nr 4 2023

Making a difference to women worldwide

Gedea Biotech has developed the world’s first antibiotic-free treatment to both treat and prevent bacterial vaginosis. The treatment is called pHyph, and is a vaginal tablet that has shown a medical effectiveness in treating bacterial vaginosis in line with antibiotics on the market, but with a superior safety profile and lower risk of recurrence.

Annette Säfholm, CEO Gedea Biotech AB.

At the time of writing, Gedea Biotech has an ongoing clinical trial to prove that pHyph can treat the common fungal infection vulvovaginal candidiasis (VVC) as well as bacterial vaginosis.

Bacterial vaginosis is a common and recurring condition for women across the world. The condition is usually treated with antibiotics, but with common side effects such as a high risk of recurring bacterial vaginosis as well as other vaginal infections, the most common being the fungal infection VVC.

“There is a great need to replace antibiotics globally. This is not only due to the common problem of bacteria developing resistance to antibiotics, but also due to the fact that antibiotics is not the best treatment for many conditions. For us, the aim to replace antibiotics revolves around the most common vaginal infections globally”, says Annette Säfholm, CEO of Gedea Biotech.

Convincing clinical results

The amount of antibiotics used in the world to treat bacterial vaginosis is tremendous, and this is despite the risk of harming the protective vaginal flora and having recurring infections. The need for a novel and antibiotic-free treatment is great on a global scale, and Gedea Biotech is the developer with the most promising results so far.

The development of pHyph is based on research from the Lund University and Gedea Biotech was founded by three chemists and one gynaecologist from the Skåne University Hospital. After several years of research and development, followed by clinical trials, pHyph has entered the next stage of development to provide proof of concept not only for treating bacterial vaginosis, but also for treating VVC. Annette Säfholm explains:

“We have an extensive clinical program. pHyph has already been through two clinical trials to provide proof of concept for bacterial vaginosis. Our next step is to prove that it is as efficient in treating vulvovaginal candidiasis, via a clinical trial that is currently ongoing. What we have found so far is that pHyph has shown a cure rate in line with antibiotics on the market for treating bacterial vaginosis with superior safety profile and a low risk of recurrence, with no risk at all in developing secondary VVC infections, as antibiotics commonly do. This is unique to our treatment and something that can really make a difference to so many women worldwide”.

Getting approved and beyond

Gedea Biotech is planning on getting pHyph approved as a medical device product in Europe. The next step after that will be to get an FDA-approval for the US. Gedea’s ambition is to enter into pivotal partnerships with a company focusing on women’s health, in order to accelerate pHyph market launch.