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Early Trial Results Show Venous Leg Ulcer Drug Efficacy

Treating venous leg ulcers today often requires compression bandages

Treating venous leg ulcers today often requires compression bandages or stockings (Pergamum AB)

The biotechnology company Pergamum AB in Solna, Sweden reports an early-stage clinical trial shows its drug to treat venous leg ulcers improved healing among patients taking the drug compared to a placebo. The trial also showed the drug, code-named LL-37, was well-tolerated at lower doses.

Venous leg ulcers are shallow wounds appearing on the skin when veins in the leg do not return enough blood toward the heart. The condition results from poor blood circulation and faulty valves in the blood vessels causing blood to back up and pool in the veins. Venous skin ulcers often heal slowly and can damage the surrounding tissue.

The standard treatment for venous leg wounds is compression bandages or stockings, with lifestyle changes, such as increased walking to improve circulation. The company cites statistics estimating the condition affects some 15 million people worldwide.

LL-37, says Pergamum, is made of a therapeutic peptide that is naturally present in the skin and formulated as a gel. The trial tested LL-37 with 34 patients having venous leg ulcers who received either a placebo or LL-37 in one of three dosage levels.

At the two lower doses — 0.5 and 1.6 milligrams/milliliter (mg/mL) — average healing rate in patients receiving LL-37 was 3 to 6 times higher than patients receiving the placebo. At the highest dose, 3.2 mg/mL, the healing rate for patients was about the same as those receiving the placebo.

At the highest dosage, says the company, patients reported an increased incidence of local reactions to LL-37, which the company says could have hindered the healing the process. At the two lower dosage levels — 0.5 and 1.6 mg/mL — the drug was well tolerated.

Pergamum was formed through a merger of three biotechnology companies in Sweden and specializes in treatments for skin disorders and wounds. The company is a portfolio enterprise of Karolinska Development, the technology commercialization arm of Karolinska Institutet in Stockholm, but having cooperative agreements with other universities in Nordic countries.

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