At Liminal, we have developed a strategy to build a broader portfolio of novel small molecule compounds over time and explore opportunities for collaboration in our small molecule development programs.
Our Small Molecule Pipeline
Our lead product candidate is fezagepras (also known as PBI-4050) which we intend to develop as a potential nitrogen scavenger. Nitrogen scavenging drugs are used in the treatment of conditions characterized by hyperammonemia 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 high ammonia can lead to confusion (encephalopathy), coma and if untreated, death.
Our most advanced preclinical program is for the development of a selective GPR84 antagonist drug product candidate designed to treat inflammation and/or fibrosis in several different therapeutic categories. We believe that the GPR84 receptor could be an important biological target in a number of therapeutic areas of interest. GPR84 is broadly expressed and may play an interesting role in the relationship between inflammation, obesity and diabetes. Our preclinical research indicates a potential role for antagonism of GPR84 in the reduction of fibrosis in several diseases, including kidney disease and Non-Alcoholic Steatohepatitis, or NASH.
In addition to GRP84, we intend to develop a novel, selective OXER1 antagonist candidate. OXER1 is a G protein-coupled receptor (GPCR that is highly selective for 5-oxo-ETE, believed to be one of the most potent human eosinophil chemo-attractants. Eosinophils play a key role in Type 2 inflammation-driven diseases, including respiratory diseases and gastrointestinal diseases. Our GPR84 antagonist and OXER1 antagonist R&D programs are currently both at the pre-clinical research stage.
Advancing the clinical development of our small molecule pipeline candidates
Our goal is to leverage our drug discovery platform and to develop distinctive novel small molecule therapeutics to treat the complex biology of inflammatory, metabolic and fibrotic disease to address significant unmet needs.
The key activities to achieve this goal include:
- Conducting further research on fezagepras and its potential effects as a nitrogen scavenger, including launching a Phase 1a, randomized, open label, cross over, single ascending dose (SAD) clinical trial to evaluate the safety, tolerability, and pharmacokinetics of fezagepras compared to sodium phenylbutyrate in healthy subjects to provide comparative data to support our development plan for fezagepras;
- Presenting the results from the fezagepras Phase 1 MAD clinical trial on completion and filing of the Clinical Study Report (“CSR”);
- Presenting the top-level results of the fezagepras Phase 1a SAD clinical trial on its completion;
- Selecting a preclinical candidate for our GRP84 antagonist program for further development;
- Actively pursuing opportunities to monetize non-core assets and to streamline costs overall; and
- Selecting a preclinical candidate for our OXER1 antagonist Program for further development.