Gedea Biotech announces the start of the clinical study VVC2025 – first patients enrolled
Gedea Biotech today announced the start of the clinical study VVC2025, following approval from the Swedish Medical Products Agency (Läkemedelsverket). The randomized and controlled study evaluates Gedea’s product pHyph for the relief of signs and symptoms of vulvovaginal candidiasis (VVC). VVC2025 is expected to generate key clinical data to support an extension of the current CE marking for treatment of bacterial vaginosis (BV) to also include treatment of signs and symptoms of VVC.
The study is funded by the EIC grant awarded to Gedea in 2024 and aims to verify the safety and efficacy of pHyph in the treatment of vaginal yeast infections, which has previously been demonstrated in the single-armed CL4 study. VVC2025 is a randomised, controlled study in which one group receives active treatment and the control group remains untreated, with a 2:1 allocation ratio. An interim analysis is planned after 36 patients have been enrolled. The study is conducted at three sites; in Stockholm, Uppsala and Linköping, and recruitment is ongoing via social media advertising.
VVC is a common condition, globally affecting approximately 175 million women annually, and most women experience it at least once in their lifetime. Symptoms are bothersome and often difficult to distinguish from those of BV, which may lead to misdiagnosis and inappropriate treatment. pHyph has the potential to offer a dual-effect treatment, treating and relieving symptoms of both BV and VVC and thereby reducing the risk of incorrect treatment choice and long-term symptoms.
On the first day of inclusion, five patients were enrolled. Helena Litorp, Specialist physician in gynecology serves as Principal Investigator for the trial:
“Vaginal candida infection is very common and can cause significant, often recurrent, discomfort for women affected. The symptoms can sometimes be difficult to distinguish from other vaginal infections, and currently available treatments do not always provide sufficient effect. It is therefore valuable to be able to offer patients more treatment options, including therapies that can address several common causes of vaginal infection,” says Helena Litorp.
“The approval and initiation of the VVC2025 study represent an important step in strengthening the clinical evidence for pHyph,” said Annette Säfholm, CEO of Gedea Biotech. “We are pleased that the first patients have already been enrolled and look forward to generating additional data to support future regulatory and commercial activities,” she concludes.