News? MAD and SAD is true. -
Analysis of PK data from Phase 1 Multi-Ascending Dose ("MAD") clinical trial completed
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Data observed shows that fezagepras has nitrogen scavenging properties
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Planned Phase 1a Single Ascending Dose ("SAD") trial, commencing in Q2 2022, to compare fezagepras with sodium phenylbutyrate as a nitrogen scavenger
LAVAL, QC and CAMBRIDGE, England, March 14, 2022 /CNW Telbec/ - Liminal BioSciences Inc. (Nasdaq: LMNL) ("Liminal BioSciences" or the "Company"), today provides 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.
"Further to our announcement in 2021 that the Company would not be progressing the development of fezagepras for the treatment of idiopathic pulmonary fibrosis nor hypertriglyceridemia, the PK data observed from the MAD study led us to conclude that, at this stage, any potential new indications to be evaluated in the development of fezagepras are not expected to be for the treatment of fibrosis", stated Dr. Jeffrey Smith, Liminal's Strategic Medical Advisor. Dr. Smith added, "The low plasma concentrations of fezagepras, combined with high level of metabolites, lead us to that conclusion. However, analysis of the metabolite data provided support for the hypothesis that fezagepras has nitrogen scavenging properties. This provides an opportunity for fezagepras' potential development in diseases associated with high plasma ammonia concentrations."
"Based on our observations that fezagepras has demonstrated nitrogen scavenging capabilities, we intend to conduct further research, including a Phase 1a SAD clinical trial designed as a head-to-head comparison with sodium phenylbutyrate to provide comparative nitrogen scavenging data to support our development plan," stated Bruce Pritchard, Chief Executive Officer of Liminal BioSciences. "This will provide us with further data to determine if fezagepras is worth developing for one of the many potential indications where nitrogen scavenging is beneficial. We have initiated work to conduct the study and expect, subject to receiving the usual approvals, to commence the Phase 1a SAD clinical trial in the second quarter of 2022. We expect to have data in the third quarter of 2022 which will support whether or not to continue developing fezagepras as a nitrogen scavenger. We look forward to providing further updates on this potential opportunity as data becomes available."
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.