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F1245/05

A groundbreaking 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 (F44/10, F125/10, F770/05, F510/08, and F1245/05) to target common bacterial strains found in diabetic foot ulcers. The study aims to compare TP-102 with a placebo, both used in addition to standard care, to determine its potential in improving infection classification, wound healing, and overall patient outcomes.

Table of Contents

What is TP-102?

TP-102 is a new medical product being developed to treat diabetic foot infections. It’s a special type of treatment called bacteriophage therapy. Bacteriophages are tiny viruses that can kill specific bacteria without harming human cells. TP-102 is a mixture (or “cocktail”) of five different bacteriophages, each designed to target specific harmful bacteria that can infect foot ulcers in people with diabetes.[1]

How Does TP-102 Work?

TP-102 is applied directly to the infected wound as a liquid (suspension). The bacteriophages in TP-102 are designed to attack and kill specific types of bacteria that commonly cause infections in diabetic foot ulcers. By eliminating these harmful bacteria, TP-102 aims to help the wound heal and improve the overall infection.[1]

What Conditions Does TP-102 Target?

TP-102 is specifically designed to treat diabetic foot ulcers that are infected by one or more of the following bacteria:[1]

  • Acinetobacter baumannii: A type of bacteria that can cause serious infections, especially in healthcare settings.
  • Pseudomonas aeruginosa: A common bacteria that can cause various infections, particularly in people with weakened immune systems.
  • Staphylococcus aureus: Often referred to as “staph,” this bacteria can cause a range of infections, from minor skin infections to more severe conditions.

Current Clinical Trial of TP-102

TP-102 is currently being studied in a Phase 2b clinical trial. This means it’s in the middle stages of testing in humans to determine if it’s safe and effective. The trial is specifically looking at how well TP-102 works when applied topically (on the skin) to treat diabetic foot infections.[1]

Who Can Participate in the TP-102 Trial?

The trial has specific criteria for who can participate. Some key points include:[1]

  • Participants must be 18 years or older
  • Have a diagnosis of Type 1 or Type 2 diabetes
  • Have a foot infection that meets certain criteria, such as:
    • Present for at least 3 weeks
    • Below the ankle
    • Not larger than 20 cm²
    • Infected with one of the bacteria that TP-102 targets

There are also several conditions that would prevent someone from participating, such as pregnancy, certain other medical treatments, or active cancer.

Objectives of the TP-102 Trial

The main goals of this clinical trial are:[1]

  1. To assess the safety and tolerability of TP-102 compared to a placebo (a treatment with no active ingredients)
  2. To see if TP-102 improves the classification of diabetic foot infections according to established medical guidelines
  3. To evaluate how TP-102 affects wound healing compared to the placebo

The researchers will also look at other factors, such as how TP-102 affects certain blood tests related to infection, how well it eliminates the target bacteria, and how it impacts overall wound healing.

Safety and Efficacy Measures

To determine if TP-102 is safe and effective, the researchers will be looking at several key measures:[1]

  • The number and type of side effects that occur during treatment
  • Changes in the severity of the foot infection
  • The percentage of patients whose wound size is reduced by at least 50% after 4 weeks of treatment
  • Changes in blood tests that indicate infection levels
  • How well TP-102 eliminates the target bacteria
  • Changes in wound size, depth, and healing progress

These measures will help determine if TP-102 is a safe and effective treatment option for people with diabetic foot infections.

Aspect Details
Study Type Phase 2b Clinical Study
Treatment TP-102 (bacteriophage cocktail) vs Placebo
Target Condition Diabetic Foot Infection
Primary Objectives Safety, tolerability, clinical improvement in infection classification, effects on wound healing
Key Inclusion Criteria Adults with diabetes, specific foot infection criteria, presence of target bacterial strains
Treatment Duration Up to 31 days
Primary Endpoints Adverse events, change in IWGDF/IDSA classification, wound surface area reduction

FAQ

  • What is TP-102 and how does it work? TP-102 is a topical bacteriophage therapy consisting of five specific bacteriophages. It works by targeting and eliminating harmful bacteria commonly found in diabetic foot infections, such as Acinetobacter baumannii, Pseudomonas aeruginosa, and Staphylococcus aureus.
  • Who is eligible for this clinical trial? Eligible participants are adults (18 years or older) with diagnosed diabetes mellitus (type I or II), an HbA1c value of 12.0% or less, and a diabetic foot infection meeting specific criteria, including the presence of at least one target bacterial strain susceptible to the TP-102 bacteriophage cocktail.
  • What are the main objectives of the study? The main objectives are to evaluate the safety and tolerability of TP-102 compared to placebo, assess its efficacy in improving diabetic foot infection classification, and determine its effects on wound healing, all in addition to standard care.
  • How long does the treatment last? The maximum treatment period for this study is 31 days, during which patients will receive daily topical applications of TP-102 or placebo on their wound.
  • What are the potential benefits of participating in this trial? Participants may experience improved wound healing, reduced infection severity, and better overall management of their diabetic foot infection. Additionally, they contribute to the advancement of medical knowledge in treating this condition.

Ongoing Clinical Trials on F1245/05

  • 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 infects and replicates within bacteria, potentially killing them. In this context, bacteriophages are used as a therapeutic agent to target harmful bacteria in diabetic foot infections.
  • Diabetic Foot Infection (DFI): An infection occurring in a foot wound of a person with diabetes, often associated with poor wound healing and increased risk of complications.
  • 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 provided to patients with a specific condition, based on current medical knowledge and practices.
  • HbA1c: Glycosylated hemoglobin, a blood test that measures average blood sugar levels over the past 2-3 months, used to diagnose and monitor diabetes.
  • PEDIS: An acronym for Perfusion, Extent, Depth, Infection, and Sensation, used to classify diabetic foot ulcers and infections.
  • Treatment Emergent Adverse Events (TEAEs): Any unfavorable medical occurrence that appears or worsens after the start of treatment in a clinical study.

References

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