Liminal BioSciences provides an update on its lead drug candidate Fezagepras
- Analysis of Pharmacokinetic Data from Multiple-Dose (“MAD”) Phase 1 Clinical Trial Completed
- Observed data show that fezagepras has nitrogen scavenging properties
- Phase 1a single ascending dose (“SAD”) trial planned, starting in Q2 2022, compare fezagepras with sodium phenylbutyrate as a nitrogen scavenger
LAVAL, QC and CAMBRIDGE, England, March 14, 2022 /PRNewswire/ – Liminal BioSciences Inc. (Nasdaq: LMNL) (“Liminal BioSciences” or the “Company”), today provides an update on further development plans for its lead compound fezagepras. This announcement follows the company’s completion of analysis of pharmacokinetic (“PK”) data from its Phase 1 MAD study of fezagepras in healthy volunteers. There were no significant findings related to drug safety in the study.
“Following our announcement in 2021 that the Company would not be advancing the development of fezagepras for the treatment of idiopathic pulmonary fibrosis or hypertriglyceridemia, the observed PK data from the MAD study led us to conclude that at this stage, any potential new indications to be evaluated in the development of fezagepras should not be for the treatment of fibrosis,” said Dr. Jeffrey Smith, strategic medical advisor to Liminal. Dr Smith added: “The low plasma concentrations of fezagepras, combined with a high level of metabolites, lead us to this conclusion. However, analysis of the metabolite data confirmed the hypothesis that fezagepras possesses nitrogen scavenging. This provides an opportunity for potential development of fezagepras in diseases associated with high plasma ammonia concentrations.”
“Based on our observations that fezagepras has demonstrated nitrogen scavenging abilities, we intend to conduct further research, including a Phase 1a SAD clinical trial designed as a direct comparison with the sodium phenylbutyrate to provide comparative nitrogen scavenging data to support our development plan,” said Bruce Prichard, CEO of Liminal BioSciences. “This will provide us with additional data to determine if fezagepras is worth developing for one of the many potential indications where nitrogen scavenging is beneficial. We have begun work to conduct the study and expect , subject to receiving customary approvals, to commence the SAD clinical trial in the second quarter of 2022. We expect to have data in the third quarter of 2022 that will allow us to decide whether or not to pursue the development of fezagepras as a nitrogen scavenger We look forward to providing further updates on this potential opportunity as data becomes available.”
Planned Phase 1a Clinical Trial Plan for SAD
Subject to obtaining the required regulatory approvals, the company plans to initiate a Phase 1a SAD, randomized, open-label, crossover study to evaluate the safety, tolerability and pharmacokinetics of a single ascending dose of fezagepras versus to sodium phenylbutyrate in healthy subjects. .
Phase 1 MAD clinical trial completed:
The company has performed a Phase 1, randomised, double-blind, placebo-controlled study designed to assess the safety, tolerability and pharmacokinetics of multiple ascending doses of fezagepras in healthy subjects.
MAD Phase 1 clinical trial results
The pharmacokinetics observed following administration of fezagepras at all doses in the clinical trial (up to 2400 mg daily for 14 days in single or divided doses) demonstrated that the major metabolite of fezagepras was the glutamine conjugate. Conjugation of fezagepras with glutamine shows that fezagepras has the potential to act as a “nitrogen-scavenging” drug. Nitrogen scavenger drugs are used in the treatment of conditions characterized by hyperammonemia. At this stage, no new potential indication for the development of fezagepras should be in the treatment of fibrosis. There were no significant findings related to drug safety in the study.
About Liminal BioSciences Inc.
Liminal BioSciences is a clinical-stage biopharmaceutical company focused on developing novel, distinctive small molecule therapies for inflammatory, fibrotic and metabolic diseases using our drug discovery platform and a research-driven approach. the data. The Company’s lead small molecule product candidate, fezagepras, has completed a Phase 1 clinical trial in MAD and the Company plans to conduct a single escalating dose Phase 1a comparative clinical trial to provide comparative data to support its development plan. In addition, the Company is also currently developing a selective GPR84 antagonist candidate and a selective OXER1 antagonist candidate. Our GPR84 and OXER1 antagonist programs are currently in the preclinical stage.
Liminal BioSciences is engaged in active business activities in Canada and the UK.
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 terms. Statements that are not historical in nature, including the words “anticipate”, “expect”, “suggest”, “plan”, “believe”, “intend”, “estimate”, ” target”, “project”, “should”, “could”, “would”, “could”, “will”, “forecast” and other similar expressions are intended to identify forward-looking statements. Such statements include those relating to objectives, strategies and activities of Liminal BioSciences that involve risks and uncertainties. Forward-looking information includes statements regarding, among other things, the advancement of Liminal Biosciences’ product candidates, the results of planned clinical trials; analysis of our data clinical trials, potential development of Liminal Biosciences’ R&D programs, properties of our lead drug candidate, timing of initiation or nature of preclinical and clinical trials, and therapeutic areas are potential.
These statements are “forward-looking” because they are based on our current expectations about the markets in which we operate 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 prove 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 market with success of product candidates, if any; the impact of the COVID-19 pandemic on the Company’s workforce, business operations, clinical development, regulatory activities and financial and other impacts on the business; the availability of funds and resources to pursue R&D projects, clinical developments, manufacturing operations or commercialization activities; the successful and timely initiation or completion of clinical trials; Liminal BioSciences’ ability to take advantage of funding opportunities or business opportunities in the pharmaceutical industry; the uncertainties generally associated with research and development, clinical trials and related regulatory reviews and approvals; and general changes in economic conditions. A more detailed assessment of these risks, uncertainties and other risks that could cause actual events or results to differ materially from our current expectations can be found in the Company’s filings and reports with the Securities and Exchange Commission. United States and Canadian Securities Administrators, including in the Annual Report on Form 20-F for the fiscal year ended December 31, 2020, as well as other filings and reports that Liminal Biosciences may make from time to time. These risks may be magnified by the ongoing COVID-19 pandemic and any related impact on Liminal BioSciences’ business and the global economy. Accordingly, we cannot guarantee that any particular forward-looking statement will occur. Existing and potential investors are cautioned not to place undue reliance on these forward-looking statements and estimates, which speak only as of the date hereof. We undertake no obligation to update the forward-looking statements contained in this press release, even if new information becomes available, as a result of future events or for any other reason, except if applicable laws and regulations of securities require it.
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