Swedish medtech innovation to make a difference to women worldwide

Gedea Biotech has developed the world’s first antibiotic-free treatment, called pHyph, to both treat and prevent bacterial vaginosis. The treatment is clinically proven to be much safer for women to use, as well as providing a lower risk of recurrence. In addition, Gedea aims to prove that pHyph can treat vulvovaginal candidiasis (VVC) as well.

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 treating common vaginal infections in a much safer and better way – providing a long-term cure for the patients”, says Annette Säfholm, CEO of Gedea Biotech.

Extensive clinical programs

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. Gedea Biotech was founded by three chemists and a gynaecologist from the Skåne University Hospital. After several years of research and development, followed by clinical trials, pHyph has passed the next stage of development and provided proof of concept not only for treating bacterial vaginosis, but also for treating VVC. Annette Säfholm explains:

“We do have an extensive clinical program. pHyph has been through two clinical trials to provide proof of concept for bacterial vaginosis. Our next step was then to prove that it is also efficient in treating vulvovaginal candidiasis, via a clinical trial that so far shows positive results.”

Conclusions from the two first studies in bacterial vaginosis are that pHyph has a cure rate in line with leading antibiotics on the market, when it comes to treating bacterial vaginosis with a superior safety profile – and a low risk of recurrence. Further, there is no risk at all in developing secondary VVC infections, as antibiotics commonly do.

Findings of the second study are still being evaluated, but initially show that VVC can be treated efficiently using pHyph.

Best bet for pHyph

Gedea is aiming to attain approval for pHyph as a medical device product in Europe. The next step after that will be to get FDA-approval.

“Our best bet for developing pHyph further, and making it available to as many women as possible, is to enter into pivotal partnerships with one or more partners in women’s health. We are looking to pursue this more during 2024”, says Annette Säfholm.

“Our product can really make a difference to so many women worldwide”, she concludes.