Bacterial vaginosis (BV) and vulvovaginal candidiasis (VCC) are common vaginal infections caused by Gardnerella and other anaerobic bacteria or by Candida fungi. The infection can occur once - the acute form - or recur repeatedly over the course of a year or even several years. Every year, about 68m women in Europe and the US have at least one vaginal infection. Vaginal infections cause intense physical discomfort, adversely affects quality of life and have heavy socioeconomic costs. Many women opt to self-treat with non-prescription over-the-counter antifungals which fail because the causative microorganism has not been properly identified. Antibiotics for BV are encountering increasing levels of drug resistance. Combination of misdiagnosis, misuse, non-compliance, overconsumption leads to low efficacy and high recurrence rates for vaginal infections.
Our solution is pHyph, a pessary based on glucono-δ-lactone that is a highly effective cure for acute and recurrent vaginal infections, providing a far better alternative to antibiotics or antifungals. We have confirmed the commercial and economic viability and biological safety of pHyph and have developed a comprehensive roadmap to complete clinical development and reach commercialisation. This project has been a crucial step to execute these plans and enter the vaginal infection treatment markets.
NEFERTITI project objectives were to fine tune the formulation of pHyph followed by a full clinical testing program to demonstrate efficacy of pHyph treating vaginal infections and preventing their recurrence. In total, 152 patients participated in pHyph clinical trials at ten clinical investigation sites. The safety and efficacy of pHyph in treating and preventing BV and its recurrence, as well as secondary VVC infections was confirmed by clinical diagnosis in the CL3/NEFERTITI study. Data gathered from the clinical studies has been essential on our route to comply with the European CE mark approval requirements, and consequent market launch in Europe, leading to a strengthened company position when negotiating with pharmaceutical enterprises to complete our distribution value chain. To support commercial viability, we have performed market maturation activities including supply chain maturation, market surveillance, legal and regulatory matters, IP protection as well as communication and dissemination activities.
