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Karolinska Development AB's Pergamum AB Reports Positive Preliminary Efficacy Results from Phase I/II Study of LL-37 in Patients with Chronic Leg Ulcers

Thursday, 4 Jul 2013 02:00am EDT 

Karolinska Development AB announced that Pergamum AB, a portfolio company of Karolinska Development AB, announced on July 4, 2013 that the primary safety and tolerability end-point was met in the randomized Phase I/II trial of LL-37 for treatment of venous leg ulcers. The data also show that patients treated with LL-37 had an improved healing rate compared with placebo. In a double blind multicenter study, 34 patients with venous leg ulcers received either placebo or one of three different doses of LL-37. The primary objective of the trial was to assess the safety and tolerability of Pergamum’s potential therapeutic peptide LL-37 in a gel formulation. Three doses of LL-37 (0.5, 1.6, and 3.2 mg/ml) were compared to placebo. Data from this clinical trial demonstrate that there are no safety concerns with LL-37. The investigational drug was well tolerated when it was applied to venous leg ulcers at the two lower doses (0.5 mg/mL and 1.6 mg/mL). However, an increased incidence of local reactions at the treated wounds was observed in the highest dose group (3.2 mg/ml). Top-line results from the trial show that patients treated with LL-37 for one month experienced an improved healing rate compared to placebo for the two lower doses. Initial analysis shows that the average healing rate in patients receiving 0.5 mg/ml or 1.6 mg/ml was three to six times higher than in the placebo group.