Gedea Biotech Reports Significant Results in Study for the Treatment of Bacterial Vaginosis

Lund, Sweden, March 12, 2025

Gedea Biotech has completed a clinical study, the NEFERTITI-2 study, for the treatment of bacterial vaginosis, showing significantly better treatment outcomes with the company’s vaginal tablet pHyph compared to the control group. This result forms the basis for the company’s application for CE marking of pHyph in Europe.

• Both primary and secondary endpoints were met
• Significantly better cure rate with pHyph treatment compared to the control group
• Patients experienced rapid symptom relief that was sustained over time
• Long-term positive effect on the vaginal microbiome

The primary aim of the study was to evaluate the effect of pHyph compared to an untreated control group. The study was designed for 92 patients, with the possibility of an interim analysis when two-thirds of the patients had completed the treatment. Already at the interim analysis of 61 patients, a statistically significant result was observed, allowing the study to be completed earlier than planned.

Clinical Results Provide Long-Term Symptom Relief

The percentage of patients cured of bacterial vaginosis increased from day 7 to day 25, showing that maintenance treatment with pHyph twice a week after the first week is effective. Maintenance treatment continued for another 9 weeks, and at follow-up via mobile app on day 35, all patients reported remaining symptom-free, which is substantially better than with antibiotic treatment. Antibiotic treatment causes secondary vaginal yeast infections in up to 5-17% of patients, whereas no yeast infections were reported in patients treated with pHyph.

Bacterial vaginosis is caused by an imbalance in the vaginal microbiome (dysbiosis). Already after 7 days of treatment with pHyph, a significant reduction in dysbiosis was observed, from 94% to 56%. For patients whose microbiome had normalized by day 25, the normal microbiome was maintained throughout the study.

The responsible investigator for the NEFERTITI-2 study was Aino Fianu Jonasson MD, PhD, former urogynecology specialist at the Women’s Research Unit, Karolinska University Hospital, Huddinge, Sweden:

–         Treatment with pHyph shows significantly better results than the control group at day 7. A large portion of the patients become symptom-free, and this persists over time, which is the most important thing for the patient. In the end, the microbiome is decisive. When the patient’s microbiome has normalized, the underlying cause of BV is gone.

Annette Säfholm, CEO of Gedea, is pleased and excited:

–         The results of the study are significant for both the primary endpoint and for important clinical parameters such as the patient’s perceived symptom relief and long-term symptom freedom. We have now applied for CE marking for pHyph and look forward to partnerships for sales in Europe and Phase 3 studies in the United States.

For further information, please contact:

Annette Säfholm, CEO Gedea Biotech

Phone: +46 708 – 91 86 81

Email: annette.safholm@gedeabiotech.com

Ton Berkien, Chairman of the Board, Gedea Biotech

Phone: +46 70- 791 49 54

Email: ton.berkien@gedeabiotech.com

About pHyph

pHyph is being developed as an antibiotic-free vaginal tablet for the treatment and prevention of both vaginal yeast infections and bacterial vaginosis (BV). pHyph is a modern treatment without antimicrobial properties, promoting a healthy vaginal environment by lowering pH and dissolving biofilm. With its dual action against both fungal and bacterial infections, pHyph increases the chances of correct self-care and leads to reduced use of antimicrobial products, thereby reducing the development of antibiotic resistance. The active ingredient GDA 001 in pHyph is a well-documented small molecule already approved as a food additive. A significantly better clinical cure rate for BV compared to the control group has been shown in a Phase 2 study, with a high safety profile and no secondary vaginal yeast infections, which are common with antibiotics.

About Bacterial Vaginosis

Bacterial vaginosis (BV) is very common, with most women experiencing it once or more in their lifetime. BV limits the lives of those affected, as the most common symptom is foul-smelling discharge. The odor can be very sharp and causes significant stress and suffering for women with BV. Today, BV is treated with antibiotics or antibacterial drugs. However, it is common for the infection to recur after treatment, as antibiotics also negatively affect the vaginal microbiome. The prevalence of bacterial vaginosis is around 23-27% worldwide. If the infection persists for a longer time, complications such as severe pelvic inflammation or premature birth during pregnancy can occur.

About Gedea Biotech

Gedea Biotech is a Swedish, innovative company in women’s health developing pHyph, an antibiotic-free vaginal tablet for the treatment and prevention of both bacterial vaginosis and vaginal yeast infections. Vaginal infections affect the lives of more than 400 million women worldwide each year, and the market is worth over $1.5 billion. Gedea’s first product is pHyph, a vaginal tablet for the treatment of bacterial vaginosis. Through a modern and scientific approach, the company’s founders have made a smart innovation that is gentle for users and provides both quick relief and long-term healing.

Gedea Biotech was founded in 2015 in Lund, Sweden, by four researchers from Lund University and Skåne University Hospital. www.gedeabiotech.com

This project is supported by the European Innovation Council  

The European Innovation Council is Europe’s flagship innovation programme to identify, develop and scale up breakthrough technologies and game changing innovations The EIC has been established under the EU Horizon Europe programme. It has a budget of €10.1 billion to support game changing innovations throughout the lifecycle from early stage research, to proof of concept, technology transfer, and the financing and scale up of start-ups and SMEs.