Gedea has received approval from the Swedish Medical Products Agency the first clinical study
Last week, the Medical Products Agency and Ethics Committee announced that they approved Gedea's first clinical study. The study is an important step towards CE marking of pHyph, which is a completely new type of treatment of vaginal infections. pHyph is expected to to treat both vaginal fungal infection and bacterial vaginosis and to become the first product on the market for the treatment of both infections.
In the study, patients with vaginal fungal infection will be treated with vaginal tablets of pHyph. The study is expected to start in late October. The aim of the study is to investigate the clinical effect of pHyph on the infection and to ensure that patients experience the treatment as user-friendly.
Today's treatments are often insufficient as they are either insufficiently effective or inadequate treatment, since the symptoms of bacterial and fungal infection may be similar.
- The study is a very important milestone for Gedea. We are very pleased that we can start the study as planned, says CEO Annette Säfholm. There are many, both within Gedea and our partners who have worked hard to get started with the study. It has been an extensive work.
Clinical results will form the basis for a CE marking later on.
The study is conducted at two gynecologist receptions in Skåne: Hoftekliniken in Helsingborg and Annerokliniken in Hofterup. Patients who have vaginal fungal infection will be asked if they want to participate in the study and try a new treatment. The study is estimated to last for three months and 24 patients will be included in the study. The study is conducted in cooperation with the Region Skåne and the Clinical Examination Unit at Lund University Hospital.
Later this fall, Gedea plans a further clinical study in which patients with bacterial vaginosis will be treated with pHyph.
- pHyph is expected to treat both vaginal fungal infection and bacterial vaginosis and thus becomes the first product on the market for the treatment of both infections. This reduces the risk that patients choose the wrong treatment for their infection, says Annette Säfholm.
About Smile Incubator
Gedea Biotech is a company in SmiLe Incubator, a business incubator in life science that helps entrepreneurs to commercialize their ideas, offering business advice, well-equipped laboratories and a large network.