Gedea Biotech has successfully completed recruitment of patients in the NEFERTITI clinical study of its lead product, pHyph, a vaginal tablet for topical treatment of bacterial vaginosis (BV).
The randomized double-blind placebo-controlled study is designed to confirm the safety and efficacy of pHyph and is coordinated by Nottingham University NHS Hospitals Trust across 6 UK and 4 Swedish sites. Results from the first treatment period (day 0-7) are expected in Q2 and for the follow-up period in Q3. This would put the company in a strong position to achieve CE-marking by the end of the year.
“Thanks to the great efforts through this difficult period of the team, Link Medical and all the clinical sites, we have succeeded in reaching this major milestone.”
“Thanks to the great efforts through this difficult period of the team, Link Medical and all the clinical sites, we have succeeded in reaching this major milestone. We believe the NEFERTITI study will confirm the previous positive results of pHyph in the treatment of bacterial vaginosis and deliver an evaluation of the long-term effect of pHyph. If positive this will enable us to aim for CE-marking by the end of the year and start commercialisation,” says Annette Säfholm, Gedea Biotech’s CEO.
Photo of Annette Säfholm
