Pipeline

Microbial adhesion – a new therapeutic target

In the past adhesion mechanisms have often been neglected in the understanding of microbial infections.

Non-pathogenic fungal spores exist in practically every person but are well controlled by the immune system (1). When these spores experience changes in the microenvironment, be it through hormonal changes or stress on the host side (2) or be it through an inflammation impulse (3), they convert into pathogenic hyphae (4). Additionally, adhesion molecules are formed that link the hyphae amongst each other to form a network (5) and at the same time to the mucosal epithelia (6), thus forming a biofilm. Biofilms prevent local antifungal drugs from reaching the location of action (7) and hyphae cannot be attacked and inactivated.

The problem of RVVC in gynecology

Over 75% of all women globally experience at least once in their lifetime a vulvovaginal candida infection. Around 5–10% never get rid of it, the infection turns into a recurrent candidiasis (RVVC), which is painful and has a strong impact on the wellbeing and quality of life of the patients. Despite marketing campaigns existing medications show very limited clinical success. Today’s standard of care in central Europe for RVVC is the permanent treatment with fluconazole, a systemic antifungal drug for 6 months. However, 50% of the patients have a relapse within 2 weeks after the termination of treatment. Commonly used medications have been on the market since the 1970s, no innovative breakthrough in RVVC treatment has occurred since then.

Lead product Candiplus “The 4 advantages”

  • 1. Mode of action: synergistic dual approach

    ProFem’s technology is based on a novel and patented synergistic effect of two registered drugs in a drug repurposing concept. While one active substance (antimycotic) is used in its common indication the second substance is specifically targeting adhesion factors.
    While the second substance effectively destroys the biofilm and removes it from the mucosa by inactivating the adhesion molecules, the first antimycotic substance can reach the hyphae and inactivate them, thus stopping the disease and preventing immediate recurrence.
    Short-term pain release is a favorable side effect.

  • 2. Safe drugs

    The drugs used for Candiplus® have been on the market for over 35 years and both have OTC status. Therefore, the safety of the drugs is well known and the occurrence of novel side effects can be excluded. Candiplus® has the potential to become an OTC soon after approval.

  • 3. Local administration

    Local administration guarantees easy use and self-administration and a fast therapeutic effect.

  • 4. Smart formulation

    In order to activate both active ingredients in the best way, a specific, innovative formulation has been developed which allows the smooth and effective administration of the drugs.

Pipeline
We work on the extension of the concept of Candiplus® to several other microbial infections.
In addition, development of a robust diagnostic tool for the detection of fungal biofilms has been initiated.