Liminal BioSciences Inc. (“Liminal BioSciences” or the “Company”), announced that the first subject has been dosed in the Company’s Phase 1a single ascending dose (“SAD”) randomized, open label, cross over clinical trial of fezagepras to evaluate the safety, tolerability, and pharmacokinetics of single ascending dose of fezagepras compared to Sodium Phenylbutyrate in healthy volunteers.
“This Phase 1a SAD clinical trial is designed as a head-to-head comparison with Sodium Phenylbutyrate to provide us with further data to determine if fezagepras is worth developing for one of the many potential indications where nitrogen scavenging is beneficial,” stated Bruce Pritchard, Chief Executive Officer of Liminal BioSciences. “Following completion of the Phase 1a SAD clinical trial we expect to have data which will support whether or not to continue developing fezagepras as a potential nitrogen scavenger therapy, and expect to provide an update on the outcome of this clinical trial in the third quarter of 2022.”
Analysis of the disproportionate metabolite data from the completed Phase 1 multi-ascending dose (“MAD”) clinical trial revealed that fezagepras’s primary metabolite was a glutamine conjugate. We believe that the conjugation of fezagepras with glutamine provides early evidence that fezagepras has the potential, subject to further research and clinical development, to act as a nitrogen scavenging drug with the potential to treat disorders associated with hyperammonaemia.
Nitrogen scavenging drugs are used in the treatment of conditions characterized by hyperammonemia (high ammonia) and target to remove ammonia from the bloodstream by conjugating with glutamine (e.g. phenylbutyrate) or glycine (e.g., benzoate) with the resulted conjugated drug being excreted in the urine. The production of glutamine in humans requires ammonia. Ammonia is highly toxic and high levels may damage many organs including the brain. Toxic effects of hyperammonemia (high ammonia) can lead to confusion (encephalopathy), coma and if untreated, death.