LIMINAL BIOSCIENCES INC. Liminal BioSciences Inc. (‘Liminal BioSciences' or the ‘Company') provided an update on plans for the further development of its lead compound fezagepras. This announcement follows the completion of the Company's analysis of the pharmacokinetic (‘PK') data from its Phase 1 MAD study of fezagepras in healthy volunteers. There were no significant drug related safety findings in the study.
Planned Phase 1a SAD Clinical Trial Design: Subject to obtaining the required regulatory approvals, the Company is planning on initiating a Phase 1a SAD, Randomized, open label, cross over, study to evaluate the safety, tolerability, and pharmacokinetics of single ascending dose of fezagepras compared to Sodium Phenylbutyrate in Healthy Subjects. Completed Phase 1 MAD Clinical Trial: The Company completed a Phase 1, randomized, double-blind, placebo-controlled study designed to evaluate the safety, tolerability, and pharmacokinetics of multiple ascending doses of fezagepras in healthy subjects. Phase 1 MAD Clinical Trial Results: The pharmacokinetics observed following administration of fezagepras at all doses in the clinical trial (up to 2400mg daily for 14 days in single or divided doses) demonstrated that the major metabolite of fezagepras was the glutamine conjugate.
The conjugation of fezagepras with glutamine shows that fezagepras has the potential to act as a ‘nitrogen scavenging' drug. Nitrogen scavenger drugs are used in the treatment of conditions characterized by hyperammonemia. At this stage, any potential new indications for the development of fezagepras are not expected to be in the treatment of fibrosis.
There were no significant drug related safety findings in the study.
