Date: 2013-10-10
Type of information:
phase: 1-2
Announcement: presentation of final data
Company: Pergamum (Sweden)
Product: LL-37
Action mechanism: LL-37 is a human peptide that is involved in acute wound healing.
Disease: hard-to-heal venous leg ulcers
Therapeutic area: Cardiovascular diseases
Country: Sweden
Trial details: 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 (0.5, 1.6, and 3.2 mg/ml). 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 principal investigator is Dr. Ola Rollman, associate professor at the Department of Medicine at Uppsala University, Sweden.
Latest
news: * On October 10, 2013, Pergamum AB, a portfolio company of Karolinska Development AB, has announced that it 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 this year. 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 this double blind multicenter study, LL-37 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 (see below).“Now that the clinical trial report has been finalized, Pergamum will focus its efforts on finding the right industrial partner to bring this novel treatment concept to market”, said Torbjörn Bjerke, CEO of Karolinska Development AB and Chairman of the Board of Pergamum.
* On July 4, 2013, Pergamum has announced 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.* On April 19, 2013, Pergamum has announced 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. The trial will be concluded in 2013. Pergamum anticipates that top line data from this study will be presented in the third quarter.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.
