Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Limerick BioPharma, a developer of therapies that help cells pump unwanted or toxic substances away from vulnerable tissues, has declared positive results of a Phase 1a trial for its lead compound LIM-0705, which has completed its first in man study.
Subscribe to our email newsletter
Limerick BioPharma said that LIM-0705 is a small-molecule compound being developed to administer alongside tacrolimus, a calcineurin inhibitor widely used to block the body from rejecting transplanted organs. Due to production of toxicities in the pancreas, brain and kidneys by tacrolimus, LIM-0705 is designed to activate specific ATP-binding cassette (ABC) transporters in these organs to pump tacrolimus out of vulnerable cells while preserving its effect against tissue rejection.
The Phase 1a trial consisted of two studies. In a single ascending dose study involving 48 subjects, LIM-0705 was assessed pharmacologically at a variety of doses. Three dose levels of LIM-0705 were then selected for a multiple ascending dose study.
In this study, 28 normal volunteers received LIM-0705 twice daily for 5 days. Pharmacokinetic parameters were again evaluated. On the final day of dosing LIM-0705, a single dose of tacrolimus was also administered. Subjects then returned two weeks later for an additional dose of tacrolimus before exiting the study.
The company claimed that no serious adverse side effects of LIM-0705 or tacrolimus were noted in this trial. According to Pharmacokinetic analysis, LIM-0705 favorably altered tacrolimus tissue distribution in a majority of subjects (P<0.001) compared to dosing tacrolimus alone. Neither GI uptake nor elimination was adversely affected.
Michael Chang, vice president of research and development at Limerick, said: “We are pleased by these results from the first completed human trial of our Activator technology. Not only is the safety data compelling, but we are encouraged by the data demonstrating an effect of LIM-0705 on the pharmacokinetics of Tacrolimus.”
Limerick BioPharma has recently begun a multi day Phase 1b study with LIM-0705 and tacrolimus. Safety and efficacy parameters including tacrolimus-induced immune suppression will be measured in this next trial.