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F125/10

A Phase 2b clinical study is underway to assess the safety and effectiveness of TP-102, a topical bacteriophage therapy, for treating diabetic foot infections. This innovative treatment combines five specific bacteriophages, including F125/10, to target common bacterial strains found in these infections. The study aims to compare TP-102 with a placebo, both used in addition to standard care, to determine its potential benefits for patients with diabetic foot ulcers.

Table of Contents

What is TP-102?

TP-102 is a new medication being developed to treat diabetic foot infections. It is a topical suspension, which means it is applied directly to the skin. TP-102 is not yet approved for general use and is currently being studied in clinical trials to determine its safety and effectiveness.[1]

How does TP-102 work?

TP-102 is a bacteriophage therapy. Bacteriophages are viruses that specifically target and kill bacteria. The medication contains a cocktail of five different bacteriophages: F44/10, F125/10, F770/05, F510/08, and F1245/05. Each of these bacteriophages is designed to attack specific types of bacteria that commonly cause foot infections in people with diabetes.[1]

What conditions does TP-102 treat?

TP-102 is being developed to treat diabetic foot ulcers that are infected by specific types of bacteria. The bacteria targeted by TP-102 include:

  • Acinetobacter baumannii: A type of bacteria that can cause serious infections, especially in healthcare settings.
  • Pseudomonas aeruginosa: A common bacteria that can cause infections in various parts of the body, including wounds.
  • Staphylococcus aureus: Often referred to as “staph,” this bacteria is a frequent cause of skin infections.

These infections can be particularly problematic for people with diabetes, as they may have difficulty fighting off infections due to poor blood circulation and nerve damage in their feet.[1]

Current research on TP-102

TP-102 is currently being studied in a Phase 2b clinical trial. This means that the medication has already been tested for basic safety in humans, and researchers are now looking at how well it works and gathering more detailed safety information. The study is comparing TP-102 to a placebo (a treatment with no active ingredients) when used alongside standard care for diabetic foot infections.[1]

The main goals of this study are to:

  1. Assess the safety and tolerability of TP-102
  2. Determine if TP-102 improves the classification of diabetic foot infections
  3. Evaluate the effects of TP-102 on wound healing

Who can participate in the TP-102 study?

The study is looking for participants who meet specific criteria, including:

  • Adults aged 18 or older
  • Diagnosed with diabetes (Type 1 or Type 2)
  • Have a foot infection that has been present for at least 3 weeks
  • The infection is caused by one of the bacteria that TP-102 targets
  • The wound is not too large (less than or equal to 20 cm²)

There are also several factors that would prevent someone from participating in the study, such as pregnancy, certain medical conditions, or participation in other clinical trials.[1]

What are the potential benefits of TP-102?

While the benefits of TP-102 are still being studied, researchers hope that it may offer several advantages over current treatments:

  • Improved healing of diabetic foot ulcers
  • Better control of bacterial infections
  • Reduced need for systemic antibiotics (antibiotics that affect the whole body)
  • Potentially faster recovery times

However, it’s important to remember that these potential benefits are still being investigated and have not yet been proven.[1]

Safety considerations

As with any new medication, the safety of TP-102 is a primary concern in the ongoing clinical trial. The researchers are carefully monitoring for any side effects or adverse reactions. Participants in the study will be closely observed for any unexpected effects of the treatment.

It’s worth noting that TP-102 is applied topically (on the skin), which may reduce the risk of systemic side effects compared to medications taken by mouth or injected. However, the full safety profile of TP-102 will only be known after the completion of this and potentially future clinical trials.[1]

Aspect Details
Study Type Phase 2b Clinical Study
Treatment TP-102 (bacteriophage therapy) including F125/10
Condition Diabetic Foot Infections
Administration Topical application on wound
Target Bacteria Acinetobacter baumannii, Pseudomonas aeruginosa, Staphylococcus aureus
Primary Objectives Safety, tolerability, clinical improvement, wound healing
Secondary Objectives Biomarker changes, bacterial eradication, wound closure
Treatment Duration Up to 31 days
Key Inclusion Criteria Age ≥18, diabetes diagnosis, specific wound characteristics
Key Exclusion Criteria Pregnancy, certain therapies, active malignancies

FAQ

  • What is TP-102 and how does it work? TP-102 is a topical bacteriophage therapy consisting of five different bacteriophages, including F125/10. Bacteriophages are viruses that specifically target and kill bacteria. In this case, TP-102 is designed to combat common bacterial strains found in diabetic foot infections, such as Acinetobacter baumannii, Pseudomonas aeruginosa, and Staphylococcus aureus.
  • Who is eligible to participate in this clinical trial? Eligible participants must be at least 18 years old, have a diagnosis of diabetes mellitus (type I or II), and have a diabetic foot infection that meets specific criteria. The infection should be present for at least 3 weeks, be below the ankle, and have a wound area of 20 cm² or less. Participants must also have at least one of the target bacterial strains susceptible to TP-102.
  • What are the main objectives of this study? The main objectives are to evaluate the safety and tolerability of TP-102 compared to a placebo, assess its effectiveness in improving diabetic foot infection classification, and determine its effects on wound healing. The study will also look at changes in infection-related laboratory markers and the eradication of target bacterial strains.
  • How is TP-102 administered? TP-102 is administered topically, meaning it is applied directly to the wound. The exact dosage and frequency of application will be determined by the study protocol and may vary depending on the individual patient's needs.
  • How long does the treatment and follow-up period last? The maximum treatment period is 31 days. However, the study includes follow-up visits to assess wound healing and other outcomes. The total duration of participation, including follow-up, may extend beyond the treatment period to fully evaluate the long-term effects of TP-102.

Ongoing Clinical Trials on F125/10

  • Study on the Safety and Effectiveness of TP-102 for Treating Diabetic Foot Infections in Patients

    Not recruiting

    2 1 1
    Investigated diseases:
    Investigated drugs:
    Poland

Glossary

  • Bacteriophage: A virus that specifically infects and destroys bacteria. In this study, bacteriophages are used as a therapeutic agent to target harmful bacteria in diabetic foot infections.
  • Diabetic Foot Infection: An infection that occurs in the foot of a person with diabetes, often as a complication of diabetic foot ulcers. These infections can be serious and may lead to amputation if not treated properly.
  • IWGDF/IDSA Classification: A system used to categorize the severity of diabetic foot infections, developed by the International Working Group on the Diabetic Foot and the Infectious Diseases Society of America.
  • Standard of Care (SoC): The typical treatment or care given to patients with a specific condition. In this study, TP-102 is being tested in addition to the standard of care for diabetic foot infections.
  • Topical Administration: The application of a medication or treatment directly to the skin or wound surface, as opposed to taking it orally or through injection.
  • Phase 2b Clinical Study: A stage of clinical research that focuses on evaluating the effectiveness and side effects of a new treatment in a larger group of patients, typically following successful Phase 1 and initial Phase 2 studies.
  • Placebo: An inactive substance or treatment used in clinical trials to compare the effects of the experimental treatment. In this study, some patients will receive a placebo instead of TP-102 to assess the true impact of the bacteriophage therapy.
  • Treatment Emergent Adverse Events (TEAEs): Any unfavorable or unintended sign, symptom, or disease that appears or worsens after the start of treatment in a clinical trial.
  • Wound Healing: The process by which damaged skin repairs itself. In this study, researchers will assess how TP-102 affects the healing of diabetic foot ulcers.
  • Eradication: The complete removal or destruction of a particular organism. In this context, it refers to the elimination of target bacterial strains from the wound site.

References

  1. http://clinicaltrials.eu/trial/study-on-the-safety-and-effectiveness-of-tp-102-for-treating-diabetic-foot-infections-in-patients/