Liminal BioSciences Announces Discontinuation of Fezagepras Development

Rhea-AI Summary

Liminal BioSciences (Nasdaq: LMNL) announced the discontinuation of fezagepras development following a Phase 1a trial that showed it was inferior to Sodium Phenylbutyrate as a nitrogen scavenger. This decision allows the company to focus on preclinical programs, including GPR84 and OXER1 antagonists targeting inflammatory and metabolic conditions. The CEO, Bruce Pritchard, emphasized that this move aligns with their strategic focus and is not related to safety concerns.

Positive

• Liminal BioSciences shifts focus to preclinical development programs after discontinuing fezagepras.
• Continues pursuit of GPR84 and OXER1 antagonists targeting key medical conditions.

Negative

• Discontinuation of fezagepras indicates a setback in product development.
• Phase 1a trial results reveal significant inferiority compared to existing treatments.

LAVAL, QC and CAMBRIDGE, England, July 21, 2022 /PRNewswire/ - Liminal BioSciences Inc. (Nasdaq: LMNL) ("Liminal BioSciences" or the "Company") today announced that it has discontinued development of fezagepras.

The decision to discontinue the development of fezagepras is based on results from the Phase 1a single ascending dose ("SAD") clinical trial, which indicated that fezagepras was significantly inferior compared to Sodium Phenylbutyrate as a nitrogen scavenger. The Phase 1a SAD clinical trial of fezagepras initiated in May 2022 was designed as a head-to-head comparison with Sodium Phenylbutyrate to provide us with further data to determine whether fezagepras was worth developing for one of the potential indications where nitrogen scavenging is beneficial. The recommendation to stop the development program for fezagepras was not based on safety concerns.

"We have come to this decisive, data driven conclusion early in Q3 in line with previously issued guidance," stated Bruce Pritchard, Chief Executive Officer of Liminal BioSciences. "This allows us to focus our resources on our preclinical development programs. We look forward to updating the market on our expected milestones for our GPR84 and OXER1 antagonists' preclinical candidates targeting inflammatory, metabolic, and fibrotic conditions. In addition to these programs, we continue to explore other development opportunities to add to our pipeline."

About Liminal BioSciences Inc.

Liminal BioSciences is a development stage biopharmaceutical company focused on discovering and developing distinctive novel small molecule therapeutics for inflammatory, fibrotic, and metabolic diseases using our drug discovery platform with a data driven approach. The Company is currently developing GPR84 antagonists and OXER1 antagonists. In addition to these programs, the Company continues to explore other development opportunities to add to its pipeline.

Liminal BioSciences has active business operations in Canada and the United Kingdom.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Some of the forward-looking statements can be identified by the use of forward-looking words. Statements that are not historical in nature, including the words "anticipate," "expect," "suggest," "plan," "believe," "intend," "estimate," "target," "project," "should," "could," "would," "may," "will," "forecast" and other similar expressions are intended to identify forward-looking statements. These statements include those related to Liminal BioSciences' objectives, strategies and businesses that involve risks and uncertainties. Forward–looking information includes statements concerning, among other things: advancement of Liminal Biosciences' product candidates, the outcome of anticipated clinical trials; the analysis of our clinical trial data; the potential development of Liminal Biosciences' R&D programs; the properties of our drug candidates; the timing of initiation or nature of preclinical and clinical trials and potential therapeutic areas.

These statements are "forward-looking" because they are based on our current expectations about the markets we operate in and on various estimates and assumptions. Actual events or results may differ materially from those anticipated in these forward-looking statements if known or unknown risks affect our business, or if our estimates or assumptions turn out to be inaccurate. Among the factors that could cause actual results to differ materially from those described or projected herein include, but are not limited to, risks associated with: the Company's ability to develop, manufacture, and successfully commercialize product candidates, if ever; the impact of the COVID-19 pandemic on the Company's workforce, business operations, clinical development, regulatory activities and financial and other corporate impacts; the availability of funds and resources to pursue R&D projects, clinical development, manufacturing operations or commercialization activities; the successful and timely initiation or completion of clinical trials; the ability to take advantage of financing opportunities or business opportunities in the pharmaceutical industry; the Company's ability to resolve the Nasdaq listing deficiency and regain compliance with the Nasdaq Listing Rules;  uncertainties associated generally with research and development, clinical trials and related regulatory reviews and approvals; and general changes in economic conditions. You will find a more detailed assessment of these risks, uncertainties and other risks that could cause actual events or results to materially differ from our current expectations in the filings and reports the Company makes with the U.S. Securities and Exchange Commission and Canadian Securities Administrators, including in the Annual Report on Form 20-F for the year ended December 31, 2021, as well as other filings and reports Liminal Biosciences' may make from time to time. Such risks may be amplified by the ongoing COVID-19 pandemic and any related impacts on Liminal BioSciences' business and the global economy. As a result, we cannot guarantee that any given forward-looking statement will materialize. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements and estimates, which speak only as of the date hereof. We assume no obligation to update any forward-looking statement contained in this press release even if new information becomes available, as a result of future events or for any other reason, unless required by applicable securities laws and regulations.

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SOURCE Liminal BioSciences Inc.

FAQ

Why did Liminal BioSciences discontinue fezagepras development?

Liminal BioSciences discontinued fezagepras due to Phase 1a trial results showing it was significantly inferior to Sodium Phenylbutyrate.

What are the next steps for Liminal BioSciences after fezagepras?

Liminal BioSciences will focus on preclinical development of GPR84 and OXER1 antagonists for inflammatory and metabolic conditions.

When did Liminal BioSciences initiate the fezagepras Phase 1a trial?

The Phase 1a trial for fezagepras was initiated in May 2022.

Is the discontinuation of fezagepras related to safety issues?

No, the decision to discontinue fezagepras was not based on safety concerns.

What is the stock symbol for Liminal BioSciences?

The stock symbol for Liminal BioSciences is LMNL.