Liminal BioSciences Inc. (Nasdaq: LMNL) (“Liminal BioSciences” or the “Company”), today provides an update on plans for the further development of its lead compound fezagepras
LAVAL, QC and CAMBRIDGE, England, March 14, 2022 /PRNewswire/ - Liminal BioSciences Inc. (Nasdaq: LMNL) (“Liminal BioSciences” or the “Company”), today provides an update on plans for the further development of its lead compound fezagepras. This announcement follows the completion of the Company’s analysis of the pharmacokinetic (“PK”) data from its Phase 1 MAD study of fezagepras in healthy volunteers. There were no significant drug related safety findings in the study. “Further to our announcement in 2021 that the Company would not be progressing the development of fezagepras for the treatment of idiopathic pulmonary fibrosis nor hypertriglyceridemia, the PK data observed from the MAD study led us to conclude that, at this stage, any potential new indications to be evaluated in the development of fezagepras are not expected to be for the treatment of fibrosis”, stated Dr. Jeffrey Smith, Liminal’s Strategic Medical Advisor. Dr. Smith added, “The low plasma concentrations of fezagepras, combined with high level of metabolites, lead us to that conclusion. However, analysis of the metabolite data provided support for the hypothesis that fezagepras has nitrogen scavenging properties. This provides an opportunity for fezagepras’ potential development in diseases associated with high plasma ammonia concentrations.” “Based on our observations that fezagepras has demonstrated nitrogen scavenging capabilities, we intend to conduct further research, including a Phase 1a SAD clinical trial designed as a head-to-head comparison with sodium phenylbutyrate to provide comparative nitrogen scavenging data to support our development plan,” stated Bruce Pritchard, Chief Executive Officer of Liminal BioSciences. “This will provide us with further data to determine if fezagepras is worth developing for one of the many potential indications where nitrogen scavenging is beneficial. We have initiated work to conduct the study and expect, subject to receiving the usual approvals, to commence the Phase 1a SAD clinical trial in the second quarter of 2022. We expect to have data in the third quarter of 2022 which will support whether or not to continue developing fezagepras as a nitrogen scavenger. We look forward to providing further updates on this potential opportunity as data becomes available.” Planned Phase 1a SAD Clinical Trial Design Completed Phase 1 MAD Clinical Trial: Phase 1 MAD Clinical Trial Results About Liminal BioSciences Inc. Liminal BioSciences has active business operations in Canada and the United Kingdom. Forward-Looking Statements 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 of Liminal BioSciences to take advantage of financing opportunities or business opportunities in the pharmaceutical industry; 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, 2020, 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. View original content:https://www.prnewswire.com/news-releases/liminal-biosciences-provides-update-on-its-lead-drug-candidate-fezagepras-301501710.html SOURCE Liminal BioSciences Inc. | ||
Company Codes: NASDAQ-NMS:LMNL |