Pergamum AB announced today that the company has reached last-patient-last-visit (LPLV) in a randomized Phase I/II trial of LL-37 for the treatment of hard-to-heal venous leg ulcers. Karolinska Development AB is the majority owner of Pergamum.
Non-healing wounds are a sizable burden for the individual patient and for the health care system. Today, there are more than 15 million patients globally, and virtually no medical progress has been made over the last few decades in regard to pharmacological treatments.
"LL-37 is a therapeutic peptide which contributes to enhanced healing of chronic wounds through its biological role in the human host defense system", said Jonas Ekblom, CEO of Pergamum AB. "This clinical trial will allow us to evaluate a promising new treatment aimed for the segment of advanced wound care products."
In this double blind multicenter study, 34 patients with venous leg ulcers have been randomized to receive either placebo or one of three different doses of LL-37. The primary objective of the trial is to assess the safety and tolerability of Pergamum's proprietary formulation of the therapeutic peptide LL-37. The trial will be concluded in 2013. The principal investigator is Dr. Ola Rollman, associate professor at the Department of Medicine at Uppsala University, Sweden.
"We look forward to evaluate the top line-data from the study, which we anticipate will be presented in the third quarter", said Torbjörn Bjerke, CEO of Karolinska Development AB and Chairman of the Board of Pergamum.