Pergamum: LL-37 Phase I/II trial meets primary end-point in patients with venous leg ulcers

Jul 4 2013

Pergamum AB, a portfolio company of Karolinska Development AB, announced today 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 a statistically significant 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 first-in-class 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 3 to 6 times higher than in the placebo group and this difference was statistically significant (p

"LL-37 is a multi-functional therapeutic peptide with unique properties. The peptide is naturally present in the skin and has an important role in wound healing", said Jonas Ekblom, CEO of Pergamum AB. "Pergamum's proprietary gel containing LL-37 has the potential to become an important treatment option for hard-to-heal wounds, a remarkably underserved disease area."

Non-healing leg ulcers are an extraordinary burden for the individual patient and for the health care system. Today, there are an estimated 15 million patients globally. The clinically most significant chronic wounds in terms of epidemiology and health economics are venous stasis ulcers, diabetic wounds, and pressure ulcers in immobile patients with reduced general condition. Despite the fact that virtually no medical progress has been made over the last few decades, the worldwide wound care market reaches annual revenues of over EUR 10bn.

"The promising study results from this clinical study, together with recent positive data from Pergamum's PXL-01 for prevention of post-surgical adhesions, significantly increases the probability of finding a strategic partner for Pergamum", said Torbjörn Bjerke, CEO of Karolinska Development AB and Chairman of the Board of Pergamum.