In the pipeline, pHyph is also being developed for vaginal fungal infections (vulvovaginal candidiasis, VVC) and for prevention of pre-term birth.
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 secondary vaginal fungal infection.
“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
Gedea Biotech was founded by three chemists and a gynaecologist from the Skåne University Hospital. The development of pHyph is based on research from Lund University. Gedea has run an ambitious clinical program in bacterial vaginosis and next step is CE-marking for treatment and prevention of bacterial vaginosis. Three clinical studies have demonstrated a clinical cure rate in bacterial vaginosis and two clinical pilot studies have shown efficacy for treating vulvovaginal candidiasis.
“We have a very ambitious development program with clinical studies so that the women using the treatment can feel confident that pHyph works and is safe to use.”
pHyph is close to market
The CE-marking process for pHyph is ongoing, estimated to reach EU approval in 2025 and to then be ready for initiating phase 3 trials for US approval as a prescription drug. Gedea aims to close partnerships with larger pharma companies for sales and marketing as well as development for regulatory approvals worldwide of the product.
Two more indications in the pipe-line
pHyph has established proof-of-concept in treatment of vulvovaginal candidiasis (VVC) in a recently finalized phase 2-trial. The dosing and administration is the same as for bacterial vaginosis. Many women would greatly benefit from an antibiotic-free, safe treatment with dual effects, as it is difficult to know what type of vaginal infection one has.
An effective treatment that reduces the risk of preterm birth would have a tremendous impact on obstetric and neonatal care worldwide. It is well-known that bacterial vaginosis and other imbalances in the vaginal microbiome during pregnancy are associated with an increased risk of preterm birth, whereas if a pregnant woman's microbiome is dominated by beneficial lactobacilli, she has a higher likelihood of giving birth full-term. In research collaboration with Karolinska Institutet, pHyph has shown to improve the healthy vaginal microbiome, especially by increasing the presence of the beneficial vaginal lactobacilli and reducing vaginal dysbiosis. Next step is to find a collaboration partner and further develop a treatment for pre-term birth.
“Our best bet for developing pHyph further is to enter into pivotal partnerships with one or more partners in women’s health. We are looking to pursue this more during 2025. We may have our eyes set on some possible partners that could take our solutions to the global market successfully, but it is still too early to reveal any names at this stage. What is most important to us is to make our product available to as many women as possible,” concludes Annette Säfholm.
