MediWound (MDWD) announced the publication of a Phase II ChronEx study in eClinicalMedicine, which evaluated the safety and efficacy of EscharEx for treating Venous Leg Ulcers (VLU). The study compared EscharEx with a placebo and non-surgical standard of care (NSSOC). Results showed EscharEx significantly outperformed the placebo and NSSOC in achieving complete debridement and promoting healthy granulation tissue. EscharEx achieved a complete debridement rate of 63% within two weeks, compared to 30.2% for the placebo and 13.3% for NSSOC. The median time to complete debridement was significantly shorter for EscharEx (9 days) versus placebo (63 days) and NSSOC (59 days). The safety profile of EscharEx was similar to both NSSOC and placebo. MediWound plans to start a Phase III study for VLUs in the second half of 2024.

Importance of Non-Surgical Debridement

Dr. John C. Lantis, Chief of Surgery at Mount Sinai West Hospital and principal investigator in the ChronEx study, emphasized the importance of this publication. He stated, “The publication in eClinicalMedicine highlights the importance of a safe and effective non-surgical treatment for debridement of chronic wounds, particularly venous leg ulcers. Removing non-viable tissue and promoting well-vascularized granulation tissue are essential steps in wound bed preparation, which is crucial for successful wound healing.” Dr. Lantis further noted that EscharEx’s significant superiority over the current non-surgical standard of care could dramatically enhance healing outcomes and provide a viable alternative to surgical debridement.

Study Overview

The Phase II ChronEx study was conducted across 20 medical centers and clinics in the United States, Europe, and Israel. Patients were randomized in a 3:3:2 ratio to receive daily treatment with EscharEx, a Gel Vehicle (placebo), or non-surgical standard of care (NSSOC), which included treatments like SANTYL®, hydrogels, medical-grade honey, and non-active dressings. The treatment duration lasted up to two weeks, with a maximum of eight daily applications or until complete debridement was achieved. Following the treatment period, patients were monitored weekly for an additional 12 weeks.

Key Outcomes

The study enrolled and treated 119 patients: 46 in the EscharEx arm, 43 in the placebo arm, and 30 in the NSSOC arm. The baseline characteristics of patients and wounds were comparable across all study arms.

Primary Endpoint

The primary endpoint of the study was the incidence of complete debridement during the two-week daily treatment period. The results were impressive:

• EscharEx: 63.0%
• Placebo: 30.2% (P = 0.004)
• NSSOC: 13.3% (P < 0.001)

Time to Complete Debridement

The median time to complete debridement was significantly shorter for EscharEx:

• EscharEx: 9 days
• Placebo: 63 days (P = 0.004)
• NSSOC: 59 days (P = 0.016)

Granulation Tissue Formation

The incidence of complete cover of the wound bed with healthy granulation tissue during the daily treatment period was:

• EscharEx: 50.0%
• Placebo: 25.6% (P = 0.01)
• NSSOC: 10.0% (P < 0.001)

Safety and Patient-Reported Outcomes

Changes in patient-reported pain, wound size, or wound quality of life (QoL) were comparable between the three treatment arms. The safety profile of EscharEx was also comparable to both NSSOC and the placebo, indicating that EscharEx is a safe option for patients.

About EscharEx

EscharEx® is a bioactive, multimodal debridement therapy designed for the treatment of chronic and hard-to-heal wounds. It is enriched with bromelain, a proteolytic enzyme, for topical daily applications. In several Phase II trials, EscharEx has been shown to be safe and well-tolerated, demonstrating efficacy in debridement, promoting granulation tissue, and reducing bioburden and biofilm in various hard-to-heal wounds, effectively preparing the wound bed for healing.

Future Studies

MediWound plans to initiate a Phase III study for Venous Leg Ulcers in the second half of 2024. Additionally, a Phase II/III study targeting Diabetic Foot Ulcers is scheduled for the second half of 2025. These studies will further investigate the potential of EscharEx in providing effective and non-surgical treatment options for chronic wounds.

Insights

1. EscharEx showed superior efficacy in wound debridement compared to current non-surgical options.
2. The study supports EscharEx as a viable alternative to surgical debridement.
3. EscharEx maintained a comparable safety profile to existing treatments.

The Essence (80/20)

Core Topics:

1. Efficacy of EscharEx: Demonstrated significant improvement in debridement and wound healing compared to placebo and NSSOC.
2. Safety Profile: EscharEx was found to be as safe as current treatments.
3. Future Plans: MediWound’s upcoming Phase III trial to further validate EscharEx’s efficacy for VLUs.

The Action Plan – What Healthcare Providers May Do Next

1. Clinical Implementation: Begin integrating EscharEx into clinical practice for VLUs where appropriate.
2. Education: Train healthcare providers on the application and benefits of EscharEx.
3. Monitoring: Establish protocols for monitoring patient outcomes and safety when using EscharEx.
4. Research and Development: Support and participate in MediWound’s upcoming Phase III trials to contribute to evidence-based practice.

Blind Spot

Potential challenges in patient adherence to daily treatment regimens and the need for comprehensive patient education on using EscharEx could be overlooked. Additionally, long-term cost-effectiveness studies may be necessary to fully establish EscharEx’s value in clinical practice.

MDWD Technical Analysis

The provided chart is of MediWound Ltd (MDWD) as of July 26, 2024. Here is a comprehensive technical analysis:

The chart shows daily candlestick data, with the stock closing at $19.80. The 50-day moving average (MA) is at $17.95, indicating an upward trend, while the 200-day MA is at $14.14, reinforcing a long-term uptrend. The stock price is above both moving averages, suggesting bullish momentum.

Volume analysis shows a spike recently, indicating increased trading activity which could be a sign of a significant price movement.

Relative Strength IndexIn the world of technical analysis, the Relative Strength Index (RSI) stands as a cornerstone tool for traders seeking insights into market momentum. Developed by J. Welles Wilder ... More (RSI) is at 56.75, which is a neutral position but leaning towards the overbought zone, suggesting potential for upward movement but with caution for possible corrections.

On Balance VolumeThe On Balance Volume indicator (OBV) is a technical analysis tool used to measure the flow of money into and out of a security over a specified period of time. It is a cumulative ... More (OBV) is at 3.529 million, showing accumulation as the volume flow is positive, supporting the price rise.

The Stochastic RSIIn the realm of technical analysis, the Stochastic RSI (StochRSI) emerges as a powerful tool for traders seeking to navigate market dynamics with precision. Developed by Tushar S. ... More is at 0.543, indicating a neutral position. It recently crossed below the overbought threshold, suggesting potential consolidation or a minor pullback before any further upward movement.

Chaikin OscillatorNamed after its creator Marc Chaikin, the Chaikin Oscillator stands as a formidable tool in the arsenal of technical analysts. This oscillator is designed to measure the accumulati... More is at -68,682, indicating negative money flow but trending upward recently, which might be an early sign of reversal or reduced selling pressure.

MACDThe MACD indicator is essentially a momentum indicator that shows the relationship between two different moving averages of price. The MACD is the difference between the 12-period ... More Oscillator shows the MACD line at 2.08 and the signal line at -0.24, with a positive histogram. This bullish crossover suggests momentum in the stock is increasing.

Time-Frame Signals:
3 Months: Buy – Given the current bullish indicators, the stock shows potential for upward movement in the short term.
6 Months: Hold – Considering the mid-term trends and moving averages, maintaining the position could be advisable as the stock consolidates.
12 Months: Buy – The long-term uptrend supported by the 200-day MA suggests the stock has potential for significant gains over a year.

Past performance is not an indication of future results, and this article should not be considered as investment advice. Always conduct your own research and consider consulting with a financial advisor before making any investment decisions 🧡.

Looking Ahead

The publication of the ChronEx study results in eClinicalMedicine marks a significant milestone for MediWound Ltd. and the field of chronic wound care. The promising results of EscharEx in treating Venous Leg Ulcers offer hope for improved patient outcomes and a viable alternative to surgical debridement. As MediWound continues to advance its clinical development programs, the potential for EscharEx to revolutionize chronic wound treatment remains strong.

Frequently Asked Questions

About the Study

What was the focus of the Phase II ChronEx study?

The study assessed the safety and efficacy of EscharEx for the treatment of Venous Leg Ulcers (VLU).

Where was the study published?

The study was published in eClinicalMedicine, a journal under THE LANCET Discovery Science umbrella.

How many medical centers participated in the study?

The study was conducted across 20 medical centers and clinics in the United States, Europe, and Israel.

How many patients were involved in the study?

A total of 119 patients were randomized and treated in the study.

What treatments were compared in the study?

Patients were treated with EscharEx, a Gel Vehicle (placebo), or non-surgical standard of care (NSSOC).

What was the primary endpoint of the study?

The primary endpoint was the incidence of complete debridement during the two-week daily treatment.

Study Results

What was the incidence of complete debridement for EscharEx?

63.0% of patients treated with EscharEx achieved complete debridement.

How did EscharEx compare to the placebo and NSSOC in terms of debridement?

EscharEx significantly outperformed the placebo (30.2%) and NSSOC (13.3%) in achieving complete debridement.

What was the median time to complete debridement for EscharEx?

The median time to complete debridement was 9 days for EscharEx.

How did EscharEx perform in promoting healthy granulation tissue?

50.0% of patients treated with EscharEx achieved complete cover of the wound bed with healthy granulation tissue.

Was there any difference in patient-reported pain, wound size, or quality of life among the treatment arms?

Changes in patient-reported pain, wound size, or wound quality of life were comparable between the three treatment arms.

What was the safety profile of EscharEx?

The safety profile of EscharEx was comparable to both NSSOC and the placebo.

About EscharEx

What is EscharEx?

EscharEx is a bioactive, multimodal debridement therapy for the treatment of chronic and other hard-to-heal wounds.

What is EscharEx made of?

EscharEx is a concentrate of proteolytic enzymes enriched with bromelain for topical, easy-to-use daily applications.

What has EscharEx demonstrated in clinical trials?

EscharEx has shown safety and efficacy in debridement, promoting granulation tissue, and reducing bioburden and biofilm in various hard-to-heal wounds.

What are the future plans for EscharEx studies?

MediWound plans to initiate a Phase III study for Venous Leg Ulcers in the second half of 2024 and a Phase II/III study for Diabetic Foot Ulcers in the second half of 2025.