Periodic Reporting for period 1 - pHyph (Breakthrough dual-action OTC tablet for treatment and prevention of both bacterial and fungal vaginitis)
Periodo di rendicontazione: 2024-04-01 al 2025-05-31
Bacterial Vaginosis (BV) and Vulvovaginal Candidiasis (VVC) are two of the most common vaginal infections affecting women globally, with over 500 million cases each year. These infections not only cause significant discomfort and reduce quality of life, but also contribute to serious health outcomes like 5.4 million preterm births annually and generate healthcare costs exceeding €3.8 billion in Europe alone.
Current treatments often rely on antibiotics and antifungal drugs, which are not always effective and contribute to the global problem of antimicrobial resistance. Gedea aims to change this with the development of pHyph—a patented, antimicrobial-free vaginal tablet that offers a new way to treat and prevent both BV and VVC without requiring lab testing to identify the specific infection. Due to its safety profile, pHyph will be available as an over-the-counter (OTC) product in pharmacies and drugstores, where most women seek help for these conditions.
The innovation lies in pHyph’s dual-action, antimicrobial-free formula and its potential to significantly reduce the use of antibiotics. The product will be brought to market using a scalable business model through partnerships with distributors and pharmaceutical companies across Europe and beyond.
Gedea’s core team brings together over 250 years of combined experience in clinical research, chemistry, regulatory affairs, marketing, and business development. The company has received recognition for its innovation, including the “Rapidus Company of the Year” award and a feature in Labiotech’s “20 European Biotech Companies to Watch.”
During the project, Gedea carries out clinical trials, obtains CE-mark certification, establishes commercial partnerships, and prepares for the product’s market launch in 2026.
Current treatments often rely on antibiotics and antifungal drugs, which are not always effective and contribute to the global problem of antimicrobial resistance. Gedea aims to change this with the development of pHyph—a patented, antimicrobial-free vaginal tablet that offers a new way to treat and prevent both BV and VVC without requiring lab testing to identify the specific infection. Due to its safety profile, pHyph will be available as an over-the-counter (OTC) product in pharmacies and drugstores, where most women seek help for these conditions.
The innovation lies in pHyph’s dual-action, antimicrobial-free formula and its potential to significantly reduce the use of antibiotics. The product will be brought to market using a scalable business model through partnerships with distributors and pharmaceutical companies across Europe and beyond.
Gedea’s core team brings together over 250 years of combined experience in clinical research, chemistry, regulatory affairs, marketing, and business development. The company has received recognition for its innovation, including the “Rapidus Company of the Year” award and a feature in Labiotech’s “20 European Biotech Companies to Watch.”
During the project, Gedea carries out clinical trials, obtains CE-mark certification, establishes commercial partnerships, and prepares for the product’s market launch in 2026.
The clinical trial has demonstrated that pHyph has a statistically significant effect in treating bacterial vaginosis and its associated fishy smell symptom, while also maintaining a healthy vaginal microbiome in a safe manner.
The main achievements thus far in the project include manufacturing batches of vaginal tablets for the clinical trials, reaching ethical approval and initiating the clinical trial to treat and prevent bacterial vaginosis, and recruitment of patients to the study. The BV clinical trial report has been finalised. Analysis of the effects on the vaginal microbiome are ongoing. The technical documentation for reaching CE mark approval of the product is being compiled and the approval process has been planned with the Notified Body. A regulatory investigation has been conducted for VVC infections and a regulatory plan for reaching approval is ongoing. Tech transfer to a commercial manufacturer has been initiated and trial batches have successfully been manufactured at the new manufacturer. Partnership discussions have been initiated for marketing and sales of the product upon regulatory approval. In addition, the business case is steadily improved, patent and trademark protection is continually being secured and market changes and project risks are being monitored.
The Gedea project team has been enlarged with key personnel within regulatory/quality/manufacturing, communication/marketing and finance.
The key next steps include obtaining regulatory approval for the product, finalising the ongoing preparations for commercial-scale manufacturing, advancing the regulatory pathway for the treatment of VVC, finalizing agreements for product launch in the European market, which will include conducting post-market investigations in real-world settings in collaboration with partners.
The main achievements thus far in the project include manufacturing batches of vaginal tablets for the clinical trials, reaching ethical approval and initiating the clinical trial to treat and prevent bacterial vaginosis, and recruitment of patients to the study. The BV clinical trial report has been finalised. Analysis of the effects on the vaginal microbiome are ongoing. The technical documentation for reaching CE mark approval of the product is being compiled and the approval process has been planned with the Notified Body. A regulatory investigation has been conducted for VVC infections and a regulatory plan for reaching approval is ongoing. Tech transfer to a commercial manufacturer has been initiated and trial batches have successfully been manufactured at the new manufacturer. Partnership discussions have been initiated for marketing and sales of the product upon regulatory approval. In addition, the business case is steadily improved, patent and trademark protection is continually being secured and market changes and project risks are being monitored.
The Gedea project team has been enlarged with key personnel within regulatory/quality/manufacturing, communication/marketing and finance.
The key next steps include obtaining regulatory approval for the product, finalising the ongoing preparations for commercial-scale manufacturing, advancing the regulatory pathway for the treatment of VVC, finalizing agreements for product launch in the European market, which will include conducting post-market investigations in real-world settings in collaboration with partners.
Thousands of women in Sweden and the UK have expressed interest in participating in the GEDEA’s clinical trials. This highlights both the unmet need and demand for novel, antimicrobial free therapeutic options. The company has raised awareness of the systemic under-treatment of women’s health issues, and promotes the key messages of the reports like McKinsey's “Closing the Women’s Health Gap”, which quantifies the societal and economic cost of neglecting women’s health. Interviews with Key Opinion Leaders, market research and discussions with potential partners prove the need for antibiotic free treatment for vaginal infections.
At the same time, Gedea has established itself as a pioneer in applied microbiome research. This application of microbiome science in a real-world therapeutic context marks a significant advance in the field. Despite limited resources, Gedea has adopted next-generation sequencing and bioinformatics methods, improving both diagnostic accuracy and treatment evaluation.
At the same time, Gedea has established itself as a pioneer in applied microbiome research. This application of microbiome science in a real-world therapeutic context marks a significant advance in the field. Despite limited resources, Gedea has adopted next-generation sequencing and bioinformatics methods, improving both diagnostic accuracy and treatment evaluation.