Project description
Non-prescription, non-antibiotic tablet treats bacterial and fungal vaginitis
Bacterial vaginosis and vulvovaginal candidiasis are the main infectious causes of vulvovaginal conditions, currently treated largely unsuccessfully with antibiotic and antifungal drugs. This treatment inefficacy leads to preterm births and decreased quality of life for women with these conditions, placing a significant burden on healthcare systems. The Swedish SME GEDEA Biotech has developed the first antibiotic-free treatment that will treat and prevent both infections simultaneously, and without requiring a test or prescription. Funded by the European Innovation Council, the pHyph project will support the multi-awarded and growing company to perform the necessary clinical trials, obtain certification and conduct the premarket activities to commercialise pHyph, bringing relief to women with a simple stop at their pharmacies or drug stores.
Objective
"There is a large unmet medical need for an efficient and highly accessible solution that can simultaneously treat and prevent BV and VVC, while removing the abuse of antibiotic and antimycotic drugs to avoid further antimicrobial resistance. The inefficacy of current solutions is demonstrated by the huge burden that BV/VCC bring to the society in terms of economic expenses (more than 3.8Bn annually), preterm births (5.4M per year), the huge prevalence of both diseases (more than 500M cases per year) and the deteriorated QoL for women. Gedea has developed pHyph, a patented pessary that due to its safe profile will be highly accessible as a first line OTC solution. pHyph is an antimicrobial-free dual solution with a new mode of action that targets both the treatment and prevention of BV and VVC, without the need of pathogen identification. pHyph will be commercialized as an OTC product in pharmacies and drug stores where 90% of women with VI look for a treatment to the infection. The business model targeted for pHyph is a well-established and successful B2B2C model for this type of product. Our business model is highly scalable via planned partnerships with distributors and pharma companies, that will facilitate accelerated commercial deployment & scale up of our business throughout Europe & beyond. Gedea core team is composed by 9 persons with over 250 years of experience combined, including experts in clinical research, bioorganic chemistry, regulatory affairs, marketing, and business development. The company received the award ""Rapidus Company of the Year"" and appeared on Labiotech's list ""The 20 European Biotech Companies to Watch in 2022"".
During this project, Gedea will perform the necessary clinical trials, CE-Mark Certification and pre-market activities to commercialize pHyph (TRL 9 by 2026). In order to do so, Gedea requires an estimated expenditure of 11.9M which is requested to the EIC through both Grant and Equity fund."
Fields of science (EuroSciVoc)
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CORDIS classifies projects with EuroSciVoc, a multilingual taxonomy of fields of science, through a semi-automatic process based on NLP techniques. See: The European Science Vocabulary.
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Keywords
Project’s keywords as indicated by the project coordinator. Not to be confused with the EuroSciVoc taxonomy (Fields of science)
Project’s keywords as indicated by the project coordinator. Not to be confused with the EuroSciVoc taxonomy (Fields of science)
Programme(s)
Multi-annual funding programmes that define the EU’s priorities for research and innovation.
Multi-annual funding programmes that define the EU’s priorities for research and innovation.
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HORIZON.3.1 - The European Innovation Council (EIC)
MAIN PROGRAMME
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Topic(s)
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Calls for proposals are divided into topics. A topic defines a specific subject or area for which applicants can submit proposals. The description of a topic comprises its specific scope and the expected impact of the funded project.
Funding Scheme
Funding scheme (or “Type of Action”) inside a programme with common features. It specifies: the scope of what is funded; the reimbursement rate; specific evaluation criteria to qualify for funding; and the use of simplified forms of costs like lump sums.
Funding scheme (or “Type of Action”) inside a programme with common features. It specifies: the scope of what is funded; the reimbursement rate; specific evaluation criteria to qualify for funding; and the use of simplified forms of costs like lump sums.
HORIZON-EIC-ACC-BF - HORIZON EIC Accelerator Blended Finance
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Call for proposal
Procedure for inviting applicants to submit project proposals, with the aim of receiving EU funding.
Procedure for inviting applicants to submit project proposals, with the aim of receiving EU funding.
(opens in new window) HORIZON-EIC-2023-ACCELERATOR-01
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Net EU financial contribution. The sum of money that the participant receives, deducted by the EU contribution to its linked third party. It considers the distribution of the EU financial contribution between direct beneficiaries of the project and other types of participants, like third-party participants.
223 81 Lund
Sweden
The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.
The total costs incurred by this organisation to participate in the project, including direct and indirect costs. This amount is a subset of the overall project budget.