Pergamum initiates LL-37 Phase I/II trial in hard-to-heal venous leg ulcers

Sep 11 2012

Pergamum AB announced today that dosing has begun in a randomized Phase I/II trial of LL-37 for the treatment of patients with hard-to-heal venous leg ulcers. Karolinska Development AB (STO: KDEV) is the majority owner of Pergamum.

"Non-healing wounds are a huge burden for the individual patient and for the health care system. Today, there are an estimated 15 million patients globally, and virtually no medical progress has been made over the last few decades", said Jonas Ekblom, CEO of Pergamum AB. "This clinical trial will allow us to evaluate a promising new treatment, based on the body's own immune defense, for patients with venous leg ulcers. The ultimate goal is to accomplish faster healing and improved quality of life for patients who typically have a poor prognosis."

In this double blind multicenter study, patients with chronic leg ulcers will be 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 Phase I/II study is expected to enroll 32 patients. The principal investigator is Dr. Ola Rollman, associate professor at the Department of Medicine at Uppsala University, Sweden.

"This is the third drug candidate developed by Pergamum that enters clinical development. It is primarily a safety study but we will also be able to see early signs of efficacy", said Torbjörn Bjerke, CEO of Karolinska Development AB and Chairman of the Board of Pergamum." The progressing of LL-37 into human trials is yet another sign of our ability to mature our project portfolio."