NEFERTITI: A Novel Eco-Friendly, dually Efficient and Resistance-free Treatment of vaginITIs

Project Information

NEFERTITI

Grant agreement ID: 835509

DOI

10.3030/835509

Project closed

EC signature date 26 November 2018

Start date 1 December 2018

End date 31 May 2019

Funded under

• INDUSTRIAL LEADERSHIP - Innovation In SMEs

Total cost

€ 71 429,00

EU contribution

€ 50 000,00

Coordinated by

GEDEA BIOTECH AB
Sweden

Periodic Reporting for period 1 - NEFERTITI (NEFERTITI: A Novel Eco-Friendly, dually Efficient and Resistance-free Treatment of vaginITIs)

Reporting period: 2018-12-01 to 2019-05-31

Summary of the context and overall objectives of the project

Bacterial vaginosis (BV) and vulvovaginal candidiasis (VCC) are common vaginal infections caused by bacteria (often Gardnerella) or yeast (a fungus) called Candida. 450 million globally experience at least 4 vaginal bacteria or Candida infections each year. It causes significant discomfort, adversely affects quality of life and is associated with heavy socioeconomic burden. To date, all treatments are limited to antifungals and antibiotics that show low efficacy and high relapse rate. With prolonged usage, misdiagnosis, and overconsumption, there is a high incidence of drug resistance, which the WHO considered one of the biggest threats to global health.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

This project has developed a business plan to guide clinical validation and commercialization of pHyph, a novel treatment targeting vaginal yeast and bacterial infections.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

Gedea has developed a vaginal tablet that contains the natural substance Glucono-δ-lactone (GDA), which switches Candida towards a benign yeast form, restores vaginal pH and disrupts the Candida and bacteria biofilm without causing treatment resistance. The yeast is removed through vaginal discharge. Since this is an antibiotic-free treatment, healthy bacteria that normally keep Candida at bay are also not removed and therefore a low relapse rate is expected with the use of pHyph. The product’s key feature lies in its ability to treat both yeast and bacterial infections and its use as both a preventative and curative treatment. These features are unmet by any other product on the market.
Preclinical research performed to date strongly supports pHyph’s novel mechanism to treat vaginal infections, reduce recurrent infections and eliminate the need for antibiotics/antimicrobials.