Breakthrough dual-action OTC tablet for treatment and prevention of both bacterial and fungal vaginitis

Introduction

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.

Current Situation

The inefficacy of current solutions is demonstrated by the huge burden that BV/VVC bring to 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)
• The deteriorated quality of life (QoL) for women

Solution Overview

Gedea has developed pHyph, a patented pessary that, due to its safe profile, will be highly accessible as a first-line OTC solution.

Product Features

• 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 for pathogen identification.
• pHyph will be commercialized as an OTC product in pharmacies and drug stores, where 90% of women with vaginal infections (VI) look for a treatment.

Business Model

The business model targeted for pHyph is a well-established and successful B2B2C model for this type of product.

Scalability

Our business model is highly scalable via planned partnerships with distributors and pharma companies, which will facilitate accelerated commercial deployment and scale-up of our business throughout Europe and beyond.

Team Expertise

Gedea's core team is composed of 9 persons with over 250 years of experience combined, including experts in:

1. Clinical research
2. Bioorganic chemistry
3. Regulatory affairs
4. Marketing
5. 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".

Project Goals

During this project, Gedea will perform the necessary clinical trials, CE-Mark Certification, and pre-market activities to commercialize pHyph (TRL 9 by 2026).

Funding Requirements

In order to do so, Gedea requires an estimated expenditure of €11.9M, which is requested from the EIC through both Grant and Equity fund.