MediWound Ltd, (Nasdaq: MDWD), a portfolio company of Clal Biotechnology Industries Ltd. (TASE: CBI), controlled by Len Blavatnik, today reported positive results in its Phase III trial in the US of its product for treatment of severe burns. The product, NexoBrid, is already approved for marketing in Europe; this trial was part of its track for gaining approval in the US. Mediwound's share price is up 15% in Nasdaq trading this evening, giving a market cap of $137 million sharply down since its IPO in March 2014.
NexoBrid, produced from the pineapple plant, is a gel designed to remove dead tissue from burn areas. The current treatment for the condition is surgery. Entering the US is likely to open a new market to the company, after sales in Europe failed to take off because the market is small and medical centers there are having difficulty adopting the new work methods. Mediwound's revenue in the third quarter of 2018 was only $1 million.
Mediwound hopes that the opening of the US market will improve its revenue, and that the additional information gained from the current trial about the product's advantages in avoiding surgery and the use of blood units will help persuade medical centers in Europe to adopt the product. The company previously announced that it was holding talks for a strategic deal.
The main target was achieved with high significance
The current trial included 175 burn victims divided into three groups: a group treated with Mediwound's product, a control group treated with a gel not containing the active ingredient, and a group given the prevailing treatment. The main target of the trial was full removal of the damaged tissue, in comparison with the control group treated with the gel sans the active ingredient. This part of the trial is essential mainly for approval of the product. The main target was achieved with a high level of significance: all of the tissue was removed in 93.3% of the patients treated with Mediwound's product, compared with only 4% of the control group.
The secondary targets were designed to provide doctors and insurance companies with information about the economic and logistic viability of using the product. All of these targets were also achieved with significance. Only 4% of the patients treated with NexoBrid also needed surgery, compared with 72% of the patients receiving the prevailing treatment. The average length of time it took to fully remove the dead issue was 1.02 days, compared with 3.83 days. The average volume of blood lost was 14.7 milliliters, compared with 814 milliliters with the current treatment. The time taken for patients to fully recover was similar for the two methods. There were no safety problems with the product.
Mediwound will continue monitoring the patients for 1-2 years, and will then submit a report on the long-term results - scars, functioning in the area of the burn, quality of life, etc. At the same time, the company does not intend to wait for these results; it hopes to register the product for marketing in the US by mid-2019.
Published by Globes, Israel business news - en.globes.co.il - on January 22, 2019
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