pHyph meets pressing medical needs

Rapid symptom relief

Longterm effect,low risk of recurrence

Does not lead to secondary fungal infection

Double effect in treating both BV and VVC

At first day of treatment many patients see a relief in symptoms and at day 7 nearly 70% report absence of symptoms. When treated, the patients stay well and after 35 days, 85% of patients are still free from BV, compared to 54-77% with antibiotics. In the pipeline, pHyph is developed for vulvovaginal candidiasis (vaginal fungal infections).

Mode of action

pHyph is formulated to a vaginal tablet and has no antimicrobial properties; instead, it positively impacts the vaginal environment by lowering pH, dissolving and preventing growth of biofilm, and promoting the growth of lactobacilli. The active ingredient GDL in pHyph is well-documented, safe, and already approved as a food additive. pHyph does not contain antibiotics or antifungals, and therefore does not lead to antimicrobial resistance.

Medical effect

pHyph provides symptom relief from the first day for most women. The bothersome odor decreases after just one day, and after 7 days, 89% report that it has decreased or is completely gone (62%-66%).

Longterm effect with pHyph

Recurrence at day 35 after start of treatment

Treatment with antibiotics have a recurrence rate of 23-46% compared to treatment with pHyph where the risk of recurrence is only 5,6-13,9%.

Rapid symptom relief

Patient´s symptom assessment of fishy smell

Rapid symptom relief is crucial for the treatment of bacterial vaginosis. At day 7, 87-89%* see reduction in fishy smell and absence of fishy smell is seen by 62-66%*

* CL3-2 n=61 patients
CL3 n=152 patients

No secondary fungal infection

No secondary fungal infection with pHyph

Current treatment with antibiotics give a secondary vaginal fungal infection in 5,6-17% of patients within 30 days from start of treatment compared to treatment with pHyph where there are no secondary fungal infections.

Bacterial vaginosis

Bacterial Vaginosis Limits Life
Bacterial vaginosis limits the life of those affected. The most common symptom of BV is a discharge from the vagina that smells like fish. The odor can be very strong and causes immense stress and suffering for women with BV. According to our own survey of 1,000 women (2020), 95% of women worry about smelling bad when they have vaginal symptoms, and 57% cannot exercise and stay active as they usually do. Because the infection often recurs, 90% of respondents worry about the symptoms returning, even when they are not currently experiencing issues.

Causes
In bacterial vaginosis, the vaginal pH is elevated compared to the normal state. This promotes the growth of primarily the bacteria Gardnerella vaginalis, leading to an imbalance in the microbiome (bacterial flora). The infectious bacteria begin to proliferate and form a film, known as a biofilm. Under this, the bacteria are further protected and thrive. pHyph lowers the pH to a normal level (4.5), dissolves and prevents biofilm formation, and restores the healthy microbiome in the vagina, thereby reducing the risk of new episodes of bacterial vaginosis.

Bacterial vaginosis can occur for no apparent reason and sometimes as a result of known factors such as a new sexual partner, bathing, or life changes like pregnancy or menopause.

Medical Need

Treatment and Recurrence

Bacterial vaginosis is currently treated with antibiotics or antiseptics that simply kill the infectious bacteria. The treatments available are often effective in the short term, and the infection typically resolves within a week. However, because antibiotics and antiseptics negatively affect the vaginal microbiome, an imbalance often occurs, leading to a recurrence of BV. Recurrences are very common; 23-46% of patients treated with antibiotics have a recurrence within 35 of days of treatment.

Secondary Yeast Infection

Treatment of bacterial vaginosis with antibiotics leads to secondary fungal infections (Candida infection) in 6-17% of patients within 30 days. While Candida is a normal component of the vaginal flora, it typically does not cause infection when the microbiome is healthy. However, antibiotics negatively impact the microbiome, reducing its resilience and allowing Candida to cause infection.

Antimicrobial Resistance

The WHO has identified antimicrobial resistance (AMR) as a global threat to public health, referring to it as “the silent pandemic,” with approximately 30,000 people in the EU dying each year as a result of AMR. It is crucial to have access to effective antibiotics when they are truly needed to treat serious infections. A significant amount of antibiotics is prescribed for treating bacterial vaginosis, in Sweden accounting for 4% of total antibiotic prescriptions. Promoting alternatives to antibiotic treatments and increasing awareness of proper usage are essential in the fight against antimicrobial resistance.