Liminal BioSciences Announces Strategic Priorities for 2022

24 January 2022 | Monday | News


Liminal BioSciences Inc. (Nasdaq: LMNL) ("Liminal BioSciences" or the "Company") today issued a report outlining its key business, research and development priorities for 2022.
Image Source : Public Domain

Image Source : Public Domain

"2021 has been an important year for us: we have simplified our business strategy and created a liquidity reserve that will allow us to focus our resources on our small molecule drug candidate business," said Bruce Pritchard,Chief Executive Officer of Liminal BioSciences. "The completion of the clinical phase of our Phase 1 MAD study for our lead product candidate fezagepras is an important milestone on the way to accelerating our R&D strategy. 2022 is expected to be a data-rich year for Fezagepras as well as for our preclinical candidates, the GPR84 antagonist and the OXER1 antagonist."

Key achievements in 2021

  • Completion of phase 1 clinical trial of the Multi-Ascending Dose ("MAD") study for Fezagepras.
  • Completion of the sale of Liminal BioSciences' plasma-derived therapeutics business to Kedrion S.p.A.
  • Completion of the sale of a Rare Pediatric Disease Priority Review Voucher.
  • Received FDA approval for ryplazim® (plasminogen, human-tvmh) ("Ryplazim®"), which was sold as part of the sale of the plasma-derived therapeutics business.

Corporate and R&D priorities in 2022

Fezagepras

In 2021, following analysis of preliminary pharmacokinetic data from our Phase I MAD clinical trial, Liminal announced that the company will discontinue the development of Fezagepras for the treatment of idiopathic pulmonary fibrosis (IPF) and hypertriglyceridemia.

Since this announcement, the Company has completed the clinical phase of the Phase I MAD study and is evaluating the resulting data. In addition, the Company is conducting further preclinical investigations and is preparing to conduct further early clinical investigations of Fezagepras to identify potential new indications. The Company is expected to report on the results of these additional research activities in the first half of 2022.

GPR84 antagonists

The company has made significant progress in identifying highly potent small molecule GPR84 antagonists, including potential selective developmental candidates from structural classes other than the GPR84 antagonists for which data have already been published.

The GPR84 receptor could be an important biological target in a number of therapeutic areas of particular interest. Our preclinical research shows that the expression of GPR84 increases significantly under inflammatory conditions. Inhibition of GPR84 appears to inhibit the migration of neutrophils and macrophages and reduce the release of cytokines. The preclinical research conducted by the company also suggests a potentially positive role of GPR84 antagonism, including in reducing fibrosis in various diseases such as kidney disease and nonalcoholic steatohepatitis (NASH).

In addition, the Company continues to work on selecting a leading drug candidate to be brought into clinical development and plans to complete the selection of the candidate in 2022.

OXER-1 antagonists

Similar to the GPR84 antagonist program, the company is also making progress in the development of potential OXER-1 antagonists.

OXER-1 is a G-protein-coupled receptor (GPCR) that is highly selective for 5-oxo-eicosatetraenioc acid (5-oxo-ETE), a powerful human eosinophil chemo attraction agent known to be involved in eosinophil-related diseases (EDDs). EDDs are inflammatory diseases, generally of the respiratory tract, gastrointestinal tract, and skin, in which elevated levels of activated eosinophils are a direct cause or believed to play a crucial role. OXER-1 could be a promising target for a new way to treat eosinophile-related diseases.

While there are a number of biologics, especially antibodies, that are approved for the treatment of certain EDDs, a small molecule approach could offer a differentiated, more cost-effective therapy in this way.

At this time, Liminal BioSciences expects to complete the selection of candidates for its OXER-1 program in 2023 to move on to clinical development.

Cash balance

The divestment of Liminal BioSciences' plasma business and the relocation of the company's headquarters from Quebec to Ontario have allowed the company to significantly streamline operations. By focusing on the development of small molecule drug candidates, it has reduced running costs and headcount. The Company's cash and cash equivalents were $116.7 million as of September 30, 2021. Additional information related to the Company's position with respect to cash and cash equivalents will be provided in the Company's reporting of its financial results for the fourth quarter and year 2021, along with the Company's progress on key priorities.

During 2022, the Company will continue to review its balance sheet position and actively seek opportunities to divest non-core assets, as well as ways to reduce costs related to financial instruments and certain obligations related to the Company's previous activities.

 

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