Limerick BioPharma, Inc., a developer of innovative therapies that help
cells pump unwanted or toxic substances away from vulnerable tissues,
has announced positive results of a Phase 1a trial for its lead
compound, LIM-0705, which has completed its first in man study.
“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.”
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. Because tacrolimus produces
toxicities in the pancreas, brain and kidneys, 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 evaluated 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.