– Gedea received approval from the Swedish Medical Products Agency
Swedish Medical Products Agency and Ethics Committee have announced that they approve Gedea’s first clinical study. The study is an important step prior to CE marking ofpHyph, which is a completely new type of treatment for vaginal infection. pHyph is expected to be able to treat both vaginal fungal infections and bacterial vaginosis and may become the first product on the market for treatment of both types of infection.
In the study, patients with vaginal fungal infection will be treated with pHyph vaginal tablets. The study is expected to start in late October. The goal of the study is to investigate the clinical efficacy of pHyph for the infection and to ensure that patients experience the treatment as user-friendly.
Current treatments are often inadequate since they either are not sufficiently effective, or the wrong treatment is chosen since the symptoms of bacterial and fungal infection may be similar.
“The study is an important milestone for Gedea. We are extremely pleased that we can start the study as planned. Many people, both within Gedea and among our partners, have worked hard to get started with the study. It has been an extensive effort,” says CEO Annette Säfholm.
The clinical results will serve as the basis for CE marking in the future.
The study is being carried out at two gynecology clinics in southern Sweden: Hoftekliniken in Helsingborg and Annerokliniken in Hofterup. Patients who have vaginal fungal infections will have the opportunity to participate in the study and try a new treatment. The study, which is expected to be three months long and include 24 patients, is being carried out in collaboration with Region Skåne and the Clinical Trial Unit at Lund University Hospital.
Later this autumn Gedea is planning an additional clinical study in which patients with bacterial vaginosis will be treated with pHyph.
“ pHyph is expected to treat both vaginal fungal infections and bacterial vaginosis and will therefore be the first product on the market for treatment of both types of infection. This will reduce the risk that patients will choose the wrong treatment for their infection and it is therefore extremely valuable for us to obtain clinical results.
Gedea Biotech is a company at SmiLe Incubator, a life science business incubator that helps entrepreneurs to commercialize their ideas by offering business advisory services, well-equipped laboratories and a strong network. Gedea Biotech is also a portfolio company of LU Holding, the holding company of Lund university.
About Gedea Biotech:
Gedea Biotech develops pHyph, an antibiotic-free, safe and effective treatment of vaginal infections. Every year, vaginal infections affect at least 400 million women worldwide and the market i worth over USD 1.5 billion. In all, 67% of women suffering from a vaginal infecction choose an ineffective treatment since they do not know whether the infection is fungal or bacterial. pHyph will be the only treatment on the market aimed at both bacterial and fungal vaginal infections, thereby reducing the risk of choosing the wrong treatment.
För mer information about Gedea Biotech: Annette Säfholm CEO, 073 4000433, firstname.lastname@example.org