Limerick to announce new results from LIM-0705 human trials at 23rd Transplantation Society congress

Jul 29 2010

Limerick BioPharma, Inc., a developer of innovative therapies that help cells pump out unwanted or toxic substances, will announce new results from human trials of its lead compound, LIM-0705, at the 23^rd International Congress of the Transplantation Society in Vancouver, Canada, in an oral presentation on August 19, 2010. The results will be presented by Dr. Daniel C. Brennan, Professor of Medicine and Director of Transplant Nephrology at Washington University School of Medicine in St. Louis.

“We are excited to begin planning for our Phase 2a study in early 2011.”

LIM-0705 is a small molecule that stimulates lipid transport. It is in development as an adjuvant therapy alongside tacrolimus, a calcineurin inhibitor used as an immunosuppressant for transplant surgery. Although tacrolimus is the gold standard in preventing solid graft rejection, it produces unwanted effects in the pancreas, brain, and kidneys which negatively impacts graft and host survival. LIM-0705 is designed to protect tissues against tacrolimus's untoward effects while preserving its anti-rejection activity.

The Company previously announced Phase 1a data establishing the safety of LIM-0705 as well as a positive effect on the ratio of blood to tissue distribution of tacrolimus. In May 2010, the Company completed a Phase 1b randomized, double-blind, placebo-controlled trial in 44 healthy male volunteers which examined the safety, tolerability, pharmacokinetics, and exploratory pharmacodynamics of LIM-0705 with or without tacrolimus. The effect of tacrolimus and placebo vs. tacrolimus and LIM-0705 on the incidence of hyperglycemia, insulin resistance, and kidney dysfunction was also examined. As expected, tacrolimus, when used with placebo, produced significant perturbations in glucose metabolism and kidney function in otherwise normal subjects over the course of the study. These effects were attenuated in subjects who were administered LIM-0705 in combination with tacrolimus.

"From our Phase 1a data, we were encouraged that LIM-0705 is effective in redistributing tacrolimus away from key organs that are vulnerable to toxicity," said Dr. Michael Chang, Limerick's Vice President of Research and Development. "This new data is the first evidence from human trials that the use of our drug can reduce unwanted physiological consequences of tacrolimus."

Limerick plans additional clinical trials for LIM-0705 that will build on these initial positive findings. "So far, the results from our clinical development program for LIM-0705 have been very positive," said Peter Butera, Senior Director of Clinical Operations. "We are excited to begin planning for our Phase 2a study in early 2011."