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Pergamum Peptide Posts Positive Results

Safety study in venous leg ulcers also shows efficacy

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

Pergamum AB, a portfolio company of Karolinska Development AB, has finalized the Clinical Study Report of a randomized Phase I/II trial of LL-37 for treatment of venous leg ulcers. Patients treated with LL-37 had a statistically significant improved healing rate compared with placebo and no safety or tolerability concerns were noted, confirming the positive preliminary data reported in July 2013.

LL-37 is a human peptide that is involved in acute wound healing. Data from independent research groups suggest that chronic wounds have a relative deficit of LL-37 and should benefit from therapeutic, exogenous application of the peptide.

In a double blind multicenter study, 34 patients with venous leg ulcers received either placebo or one of three different doses of LL-37 (0.5, 1.6, and 3.2 mg/ml) of Pergamum’s potential first-in-class therapeutic peptide LL-37 in a gel formulation. The primary objective of the trial was to assess the safety and tolerability and the data 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).

The results also show that the healing rate for the patients who received the lowest dose (0.5 mg/ml) and the middle dose (1.6 mg/ml) of LL-37 were approximately 6 and 3-fold higher respectively, compared to the patients who received placebo (p=0.003 for 0.5 mg/mL and p=0.088 for 1.6 mg/ml). There was no improvement in healing rate in the highest dose group. The clinical trial report thereby confirms the positive top-line data reported earlier this year.

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