Pergamum, a portfolio company of Sweden-based investment company Karolinska Development, says that the primary safety and tolerability end-point was met in the randomized Phase I/II trial of human multifunctional peptide LL-37 for treatment of venous leg ulcers.
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 first-in-class therapeutic peptide LL-37 in a gel formulation.
Three doses of LL-37 (0.5mg, 1.6mg, and 3.2mg/ml) were compared to placebo. Pergamum said data from the clinical trial demonstrate that there are no safety concerns with LL-37 and that it was well tolerated when it was applied to venous leg ulcers at the two lower doses (0.5mg/mL and 1.6mg/mL). However it reported an increased incidence of local reactions at the treated wounds observed in the highest dose group (3.2mg/ml).
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