LAVAL, QC and CAMBRIDGE, England, May 23, 2022
/CNW/ - Liminal BioSciences Inc. (NASDAQ: LMNL) ("Liminal
BioSciences" or the "Company"), today announced that the first
subject has been dosed in the Company's Phase 1a single ascending
dose ("SAD") randomized, open label, cross over clinical trial of
fezagepras to evaluate the safety, tolerability, and
pharmacokinetics of single ascending dose of fezagepras compared to
Sodium Phenylbutyrate in healthy volunteers.
"This Phase 1a SAD clinical trial is designed as a head-to-head
comparison with Sodium Phenylbutyrate to provide us with further
data to determine if fezagepras is worth developing for one of the
many potential indications where nitrogen scavenging is
beneficial," stated Bruce Pritchard,
Chief Executive Officer of Liminal BioSciences. "Following
completion of the Phase 1a SAD clinical trial we expect to have
data which will support whether or not to continue developing
fezagepras as a potential nitrogen scavenger therapy, and expect to
provide an update on the outcome of this clinical trial in the
third quarter of 2022."
About Fezagepras
Analysis of the disproportionate metabolite data from the
completed Phase 1 multi-ascending dose ("MAD") clinical trial
revealed that fezagepras's primary metabolite was a glutamine
conjugate. We believe that the conjugation of fezagepras with
glutamine provides early evidence that fezagepras has the
potential, subject to further research and clinical development, to
act as a nitrogen scavenging drug with the potential to treat
disorders associated with hyperammonaemia.
Nitrogen scavenging drugs are used in the treatment of
conditions characterized by hyperammonemia (high ammonia) and
target to remove ammonia from the bloodstream by conjugating with
glutamine (e.g. phenylbutyrate) or glycine (e.g., benzoate) with
the resulted conjugated drug being excreted in the urine. The
production of glutamine in humans requires ammonia. Ammonia is
highly toxic and high levels may damage many organs including the
brain. Toxic effects of hyperammonemia (high ammonia) can lead to
confusion (encephalopathy), coma and if untreated, death.
About Liminal BioSciences
Inc.
Liminal BioSciences is a clinical stage biopharmaceutical
company focused on developing distinctive novel small molecule
therapeutics for inflammatory, fibrotic, and metabolic diseases
using our drug discovery platform and a data driven approach. The
Company's lead small molecule product candidate, fezagepras, has
entered a Phase 1a single ascending dose clinical trial in
May 2022 in the United Kingdom to provide comparative data
with Sodium Phenylbutyrate, an established nitrogen scavenging
drug, 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 at the preclinical stage.
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
therapeutics 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.