A Phase 2b Clinical Study to Evaluate the Safety and Efficacy of Topical Administration of Bacteriophage Therapy TP-102 in Patients with Diabetic Foot Infection

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Technophage Investigacao E Desenvolvimento Em Biotecnologia S.A.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Skin and Connective Tissue Diseases [C17], Diseases [C] - Bacterial Infections and Mycoses [C01]

Trial duration

completed 19 Dec 2025

Decision date (initial)

2024-01-22

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Technophage, SA

External identifiers

EU CT number

2023-507716-13-00

ClinicalTrials.gov

NCT05948592

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy

Safety:
1. Safety and tolerability of TP-102 as compared to Placebo, in addition to Standard of Care (SoC);
Efficacy:
2. Clinical improvement in diabetic foot infection classification (IWGDF/IDSA) of TP-102 as compared to Placebo, in addition to SoC;
3. Effects of TP-102 on wound healing as compared to Placebo, in addition to SoC.

Secondary objectives 5

1. Improvement in DFI-related laboratory biomarkers;
2. Efficacy as measured by eradication of TP-102 susceptible strains;
3. Percentage of patients with target strain not-susceptible to TP-102 at End of Treatment (EOT);
4. Changes in wound/ulcer healing from baseline;
5. Changes in wound infection scores (DFUWI) of TP-102 as compared to Placebo, in addition to SoC.

Conditions and MedDRA coding

Diabetic foot ulcers infected by Acinetobacter baumannii, Pseudomonas aeruginosa and /or Staphylococcus aureus

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 9

1. Aged ≥18 years old;
2. Established diagnosis of Diabetes Mellitus (type I or II);
3. Glycosylated hemoglobin (HbA1c) value ≤ 12.0%;
4. Designated foot infection meets the following criteria: a. Present for at least 3 weeks; b. Below-ankle, full-thickness, cutaneous ulcer; c. Wound area (after debridement, if applicable) below or equal to 20.0 cm2; d. IWGDF/IDSA classification of Mild to Moderate / PEDIS infection grade 2 or 3; e. PEDIS perfusion grade 1 or 2; f. PEDIS depth grade 1 or 2 (grade 3 at the discretion of the investigator e.g. if they have received appropriate surgical treatment to remove infected bones).
5. Diabetic foot infection with at least one target bacterial strain (Pseudomonas aeruginosa, Staphylococcus aureus or Acinetobacter baumannii), susceptible to the TP-102 bacteriophage cocktail, as assessed from wound cultures;
6. Patients with suitable physical and mental health as determined by the Investigator based on medical history and general physical examination;
7. A woman of childbearing potential (WOCBP) (including egg donors) must have a negative Serum Pregnancy Test at screening
8. WOCBP must agree to use one of the following forms of birth control whilst receiving study medications and for 4 (four) weeks after stopping study medications: a. Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: a. Oral b. Intravaginal c. Transdermal b. progestogen-only hormonal contraception associated with inhibition of ovulation: a. Oral b. Injectable c. implantable c. Intrauterine device (IUD) d. Intrauterine hormone-releasing system (IUS) e. Bilateral tubal occlusion f. Vasectomised partner g. Sexual abstinence
9. ICF signed voluntarily before any study-related procedure is performed, indicating that the patient understands the purpose of, and procedures required in the study and is willing to participate in the study.

Exclusion criteria 8

1. Infected study ulcer less than 2 cm away from other ulcers, in the case of multiple ulcers;
2. Patient receiving Hyperbaric Oxygen Therapy (HBOT), Negative Pressure Wound Therapy (NPWT), Bioengineering Skin (BES) substitutes and/or growth factors;
3. Presence of active malignant or benign tumors of any kind, (with exception to nonmelanoma skin cancer as per investigator’s discretion);
4. Being pregnant or breastfeeding;
5. Currently participating in another clinical trial or having participated in a previous clinical trial with receipt of an investigational product within 30 days of the first administration of IP;
6. A condition that, in the opinion of the Investigator, could compromise the well-being of the patient or course of the study, or prevent the patient from meeting or performing any study requirements;
7. Patient which, in the opinion of the investigator, may not comply with study related procedures;
8. Participants with hypersensitivity to any component of investigational products.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 3

1. Number and percentage of Treatment Emergent Adverse Events (TEAEs) [Day 1 (Baseline) to EOT];
2. Statistically significant change in the percentage of patients in the respective IWGDF/IDSA classes for TP-102 versus Placebo, in addition to SoC [Day 1 (Baseline) to EOT];
3. Percentage of patients that achieve at least 50% reduction in wound surface area by week 4 for TP-102 versus Placebo, in addition to SoC [Day 1 (Baseline) to EOT].

Secondary endpoints 7

1. Change in mean CRP/ESR/PCT/WBC count value for TP-102 versus Placebo, in addition to SoC [Day 1 (Baseline) to EOT];
2. Percentage of patients with a value over clinical diagnostic cut-off for DFI for CRP/ESR/PCT/WBC count for TP-102 versus Placebo, in addition to SoC [Day 1 (Baseline) to EOT];
3. Percentage eradication of TP-102 susceptible strains for TP-102 versus Placebo, in addition to SoC, at EOT;
4. Percentage of patients with target strain not-susceptible to TP-102 for TP-102 versus Placebo, in addition to SoC, at EOT;
5. Changes in wound size, depth, granulation and partial closure (25%, 50%, 75%)from baseline, for TP-102 versus Placebo, in addition to SoC [Day 3, 8, 15, EOT and EOS].
6. Percentage of patients that achieve wound healing (complete wound closure) by EOS for TP-102 versus Placebo, in addition to SoC [Day 1 (Baseline) to FUP2].
7. Total Area Under the Curve (AUC) of the mean DFUWI score for TP-102 versus Placebo, in addition to SoC [Day 1 (Baseline) to EOT].

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Technophage Investigacao E Desenvolvimento Em Biotecnologia S.A.

Sponsor organisation

Technophage Investigacao E Desenvolvimento Em Biotecnologia S.A.

Address

Edificio Egas Monia Sala A8, Avenida Professor Egas Moniz Piso 2 Avenida Professor Egas Moniz Piso 2

City

Lisbon

Postcode

1649-028

Country

Portugal

Scientific contact point

Organisation

Technophage Investigacao E Desenvolvimento Em Biotecnologia S.A.

Contact name

Margarida Barreto

Public contact point

Organisation

Technophage Investigacao E Desenvolvimento Em Biotecnologia S.A.

Contact name

Margarida Barreto

Third parties 5

Locations

1 EU/EEA country · 5 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 12 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications