This project will develop a business plan to guide clinical validation and commercialization of pHyph, a novel treatment targeting vaginal yeast and bacterial infections.
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.
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. The proposed project will further prepare pHyph for a clinical trial. SME Instrument funding will allow Gedea to close the gap on the road towards commercialisation.
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