Pergamum, a portfolio company of Karolinska Development, has reported positive efficacy data from a Phase I/II study of a first-in-class therapeutic peptide, LL-37, developed to treat patients with chronic leg ulcers.
The randomised study met the primary safety and tolerability end-point and the subjects treated with LL-37 in a gel formulation demonstrated a statistically significant improved healing rate against placebo.
Karolinska Development CEO and Pergamum board chairman Torbjörn Bjerke said, “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.”
A total of 34 patients with venous leg ulcers were administered with either placebo or one of three different doses, 0.5, 1.6, and 3.2mg/ml of LL-37 in the double blind, multicentre study.
LL-37 was tolerated well, with no safety concerns at the two lower doses when treated for one month, while an increased incidence of local reactions at the wound site was noted in the highest dose.
The average healing rate was three to six times higher in patients receiving 0.5mg/ml or 1.6mg/ml than in the placebo group with statistically significant difference, according to the initial analysis.
Pergamum CEO Jonas Ekblom said the multifunctional therapeutic peptide LL-37 is naturally present in the skin and has an important role in wound healing.
“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,” Ekblom added.