Evaluation of Udonitrectag (MT8) in Combination with Standard Care for Safety and Pharmacokinetics in Diabetic Foot Ulcer Treatment

The primary objective of this study is to evaluate the **safety**, tolerability, and pharmacokinetic profile of **udonitrectag** (MT8) when added to the standard of care, compared to the standard of care alone, in the treatment of **Diabetic Foot Ulcers**. This is clinically relevant as it aims to establish the potential benefits and risks associated with the addition of udonitrectag to existing treatment protocols, potentially improving patient outcomes in managing this chronic condition.

Secondary objectives include determining and comparing the ability of two doses of udonitrectag in promoting the reduction of the ulcer area during a 6-week treatment period. This aspect of the study seeks to provide insights into the efficacy of different dosing regimens, which could inform future therapeutic strategies for optimizing ulcer healing in patients with diabetic foot ulcers.

The clinical trial focuses on individuals diagnosed with **Diabetic Foot Ulcer**, aiming to evaluate the safety, tolerability, and pharmacokinetic profile of udonitrectag (MT8) in conjunction with standard care. The study population includes both male and female participants, aged 18 years and older, with a diagnosis of type 1 or type 2 diabetes mellitus. Participants are required to have a diabetic foot wound classified as grade I or II according to the TEXAS diabetic wound classification system and grading 1 on the PEDIS infection scale. The trial includes individuals with ulcers not healing with standard care over the past two weeks, with an ulcer area reduction of less than 20% compared to baseline. The presence of an ulcer with an area ranging from 2 to 15 cm², measured by the MolecuLight i:XTM Wound Imaging Device, is necessary. Participants must have a Transcutaneous Oxygen Pressure (TpO2) of at least 30 mmHg or an Ankle Brachial Index (ABI) of 0.70 or higher. The trial population selection criteria include the requirement for females of childbearing potential to have a negative urine pregnancy test and use highly effective contraception. Males with partners of reproductive potential must use condoms or other effective contraception methods. The sponsor has not provided the total number of participants involved in the study.

The clinical trial is designed to evaluate the **safety**, tolerability, and pharmacokinetic profile of **udonitrectag** (MT8) when added to standard care compared to standard care alone in the treatment of **diabetic foot ulcers**. This trial is structured as a randomized, double-blind, controlled study, integrating both Phase I and Phase II components. The estimated duration of the trial spans from July 1, 2021, to March 31, 2025. Participants will be involved in the study for a period of 6 weeks, during which they will undergo a series of study visits.

The sequence of study visits begins with an inclusion (screening) visit, where eligibility is assessed based on criteria such as age, diabetes diagnosis, and ulcer characteristics. Following successful screening, participants will be randomized to receive either the investigational product, **udonitrectag**, or a placebo, both administered as a solution for external use. Subsequent follow-up visits will occur at regular intervals to monitor safety, tolerability, and efficacy, with primary endpoints focusing on the nature, frequency, severity, and timing of adverse events, as well as clinical laboratory results. The secondary endpoint will assess the efficacy by measuring the percentage of patients achieving at least a 50% reduction in ulcer area from baseline during the treatment period.

The end-of-study visit will conclude the participant's involvement, where final assessments will be conducted to evaluate the overall outcomes of the treatment. Participants may be withdrawn from the study early if they experience significant adverse events, fail to comply with study procedures, or if the investigator deems it necessary for their safety. The trial aims to provide valuable insights into the potential benefits of **udonitrectag** in managing diabetic foot ulcers, contributing to the development of more effective treatment strategies.

The clinical trial involves the experimental medication **Udonitrectag**, a neurotrophins mimetic compound, which is being evaluated for its safety, tolerability, and pharmacokinetic profile in the treatment of **diabetic foot ulcers**. Udonitrectag is formulated as a **solution for external use** and is applied locally. The active substance, also named Udonitrectag, is of chemical origin. The medication is not a pediatric formulation and is not classified as an orphan drug. The administration involves local application directly to the affected area, with the frequency of administration determined by the study protocol. Participant compliance with the dosing schedule is monitored throughout the trial to ensure adherence to the treatment regimen.

In addition to the experimental treatment, the study includes a standard-of-care therapy for diabetic foot ulcers, which serves as a comparator treatment. This standard-of-care therapy is administered according to established medical guidelines and practices. The trial aims to compare the effects of Udonitrectag in conjunction with standard care against the standard care alone. The study does not utilize a placebo control group. The trial's main objective is to assess the added benefit of Udonitrectag when used alongside standard treatment protocols.

Efficacy in the clinical trial for the treatment of **Diabetic Foot Ulcers** with the investigational product Udonitrectag will be assessed through a secondary endpoint. The primary measure of efficacy is the percentage of patients achieving a reduction in ulcer area of at least 50% from baseline during a 6-week treatment period. This percentage change in ulcer area is calculated using the formula: ((Area₀ - Area_t)/Area₀)*100, where Area₀ is the baseline ulcer area and Area_t is the ulcer area at a given time point during the treatment.