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. In order to focus on this strategy, we have decided to divest our plasma business. The key elements of our strategy include:
Advancing the clinical development of our small molecule pipeline candidates
Fezagepras, our lead candidate, has been proven in pre-clinical models to be an anti-inflammatory and anti-fibrotic agent. In December 2020, fezagepras entered a Phase 1 multi-ascending dose clinical trial in the UK to evaluate multiple-ascending doses (MAD) in normal healthy volunteers, at daily dose exposures higher than those evaluated in our previously completed Phase 2 clinical trials.
The Company is continuing to evaluate the interim PK results. Once the MAD study is complete, the Company expects that a full analysis of the complete PK data set from the phase 1 study will help determine the choice of any potential indication(s) for further development of fezagepras. No dose-limiting adverse events or other potential safety signals have been observed in the MAD study to date.
Our early-stage drug development efforts are focused on expanding our R&D pipeline both for the treatment of diseases associated with fibrosis and for other inflammatory diseases. Accordingly, alongside fezagepras, we intend to develop oral, selective GPR84 antagonists to treat fibrosis, primarily for patients with respiratory and renal disease. GPR84 is a pro-inflammatory target primarily expressed on cells associated with the immune system and its expression levels increase significantly during periods of inflammatory stress.
In addition to GRP84, we intend to develop a novel, selective OXER1 antagonist candidate. OXER1 is a 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.
Continue our process to evaluate potential strategic alternatives for the Company’s plasma-derived therapeutics business and related non-core assets
We completed our Phase 2/3 clinical trial evaluating Ryplazim in pediatric and adult patients with congenital plasminogen deficiency in October 2018. Through its’ US subsidiary, Prometic Biotherapeutics Inc., the Company resubmitted a BLA in September 2020 with the FDA seeking approval to treat patients with hypoplasminogenemia. The FDA granted approval on the 4th June 2021, as the first approved treatment for plasminogen deficiency type 1.
Following a review of our corporate business strategy, aimed at maximizing the use of capital resources, we havedecided to re-focus resources on oursmall molecule therapeutics business. We have therefore determined that the plasma-derived therapeutics business is no longer aligned with this new corporate business strategy. We believe that such change in our business strategy will allow us to become more streamlined and with a singular focus on our core research capabilities and emerging pipeline.
As previously disclosed, In May 2021 we divested our plasma collection centers operated in Winnipeg, Manitoba and Amherst, New York, through our subsidiaries, Prometic Plasma Resources Inc., and Prometic Plasma Resources (USA) Inc. to Kedrion S.p.A. (“Kedrion”) of our In conjunction with the sale the Company entered into an option agreement with Kedrion for the right to acquire the remainder of the Company’s plasma-derived business, including the Ryplazim business operated through its subsidiaries, Prometic Bioproduction Inc., the Company’s plasma-derived therapeutics manufacturing facility (“PBP”), and Prometic Biotherapeutics Inc. (“PBT”), holder of the biological license application (“BLA”) for Ryplazim® (Plasminogen) (“Ryplazim®”).