- LMNL6326 nominated as lead preclinical
candidate for OXER1 antagonist development program,
targeting the treatment of eosinophil-driven diseases
- Advancement of clinical trial application (CTA) enabling
preclinical studies of LMNL6511 to support CTA filing for Phase 1
clinical trial in H2 2023
- Insights gained from In Vivo preclinical
studies of LMNL6511 to further refine potential indications'
spectrum
- GPR40 agonist development program on
track
LAVAL,
QC and CAMBRIDGE,
England, June 2, 2023 /CNW/ - Liminal BioSciences
Inc. (Nasdaq: LMNL) ("Liminal BioSciences" or the
"Company"), announced today that the Company has nominated a
lead preclinical candidate, LMNL6326, for the development of its
OXER1 antagonist program, targeting the treatment of
eosinophil-driven diseases.
"We are pleased to be nominating LMNL6326 as our second
preclinical candidate of 2023, strengthening our development
pipeline and validating our G protein-coupled receptor drug
discovery engine," stated Bruce
Pritchard, Chief Executive Officer of Liminal BioSciences.
"We are excited to be working on an antagonist for the OXER1
receptor, providing a significant opportunity in a large and
growing global eosinophil-driven diseases market. We hope that
LMNL6326 could be a potential product candidate for the treatment
of eosinophil-driven diseases which may include eosinophilic asthma
and atopic dermatitis."
Eosinophil-driven diseases (EDD) such as eosinophilic asthma and
atopic dermatitis represent a significant area of unmet need
in global health. According to the World Health Organisation,
globally, asthma, including eosinophilic and severe asthma,
affected an estimated 262 million people in 2019 and caused 455,000
deaths.
Market Watch Research has estimated that the global eosinophilic
and severe asthma markets are expected to reach USD $127 million by 2029. Published research has
estimated the prevalence of atopic dermatitis to be 15-20% in
children and 1-3% in adults, and the incidence has increased by 2
to 3-fold during the past decades in industrialized countries.
Based on data from Future Market Insights, it is expected that the
growing global atopic dermatitis market may reach USD $7.6 billion by 2029. The proposed indication
area for our OXER1 antagonist program has not been finalised.
GPR84 Antagonist Development
Program
The Company is also pleased to report advancement of CTA
enabling in vivo studies evaluating LMNL6511, our
GPR84 antagonist candidate selected for clinical development. Data
from these preclinical studies supports progression
towards a CTA filing for a Phase 1 first-in-human clinical trial in
healthy subjects in the second half of 2023.
"The significant advancement of in vivo preclinical
studies is an integral step towards the CTA filing for our GPR84
antagonist program," stated Gary
Bridger, Interim Chief Scientific Officer of Liminal
BioSciences. "This data brings us closer to advancing LMNL6511 into
first-in-human clinical trials where we hope to identify an early
indicator of biological activity in humans."
Preclinical Study
Results for our GPR84 Antagonist Development
Program
Key takeaways from our IBD and NASH/liver related in vivo
studies include:
Insights from NASH/liver related in-vivo experiments
- Results suggest that treatment with a small molecule GPR84
antagonist for 6 weeks could improve liver fibrosis and health in a
model of diet-induced liver disease (High fat diet).
Insights from IBD in-vivo experiments
- Results showed a reduction in the number of
indomethacin-induced lesions and macroscopic disease grade in rats
dosed with LMNL6511.
- Results also showed an improvement in the albuminemia
(indicating reduction in gut bleeding) in dosed animals.
- Our data supports a positive effect of LMNL6511 on
indomethacin-induced gut inflammation in this animal model.
Insights from in-vitro experiments
• Our results showed that LMNL6511 is a significantly more
potent inhibitor of GPR84 than reported antagonists, including
GLPG1205 which has since been discontinued, potentially leading to
lower effective plasma concentrations in humans.
"We are pleased to have made progress with preclinical R&D
work for LMNL6511, and to see results from various gold standard
animal models," stated Bruce
Pritchard, Chief Executive Officer of Liminal BioSciences.
While we have not yet finalised the proposed indication areas for
the GPR84 antagonist program, this data will help to further refine
the potential indication areas with a lead towards liver diseases
and IBD."
GPR40 Agonist Development
Program
The Company also reported that its GPR40 agonist discovery
program is well underway and the Company aims to identify potent,
low molecular weight GPR40 agonists without significant PPARy
activity in 2023.
Corporate
The nomination of LMNL6326 as the lead preclinical candidate for
the OXER1 antagonist represents a milestone event pursuant to the
share purchase agreement, or SPA, dated July 17, 2020, entered into between the Company
and the selling shareholders listed thereto, wherein the Company
acquired 100% of the issued and outstanding common shares of
Fairhaven Pharmaceuticals Inc., or Fairhaven, a company with a preclinical
research program of small molecule antagonists. As a result of the
achievement of this milestone event, the Company has an obligation
to pay an additional amount of $1,312,399 to the selling shareholders, in the
proportions set out in the SPA, payable by issuing a number
of common shares of the Company equal to the amount of the
milestone payment divided by the five-trading day volume weighted
average trading price, or VWAP, of the Company's common shares on
Nasdaq immediately preceding the milestone payment date.
About Liminal BioSciences
Inc.
Liminal BioSciences is a development-stage biopharmaceutical
company focused on discovering and developing novel and distinctive
small molecule therapeutics that modulate G protein-coupled
receptor pathways (GPCRs). The Company is designing proprietary
novel small molecule therapeutic candidates with the intent of
developing best/first in class therapeutics for the treatment of
metabolic, inflammatory and fibrotic diseases with significant
unmet medical needs, using its integrated drug discovery platform,
medicinal chemistry expertise and deep understanding of GPCR
biology. The Company's pipeline is currently made up of three
programs. The candidate selected for clinical development,
LMNL6511, a selective antagonist for the GPR84 receptor, is
expected to commence a Phase 1 clinical trial in the second half of
2023. The Company is also developing LMNL6326 as an antagonist for
the OXER1 receptor, targeting treatment of eosinophil-driven
disease, and GPR40 agonists, both of which are at the preclinical
stage. 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' candidates or development programs, including
the timing and outcome of the potential development of the
Company's R&D programs such as the development of LMNL6511,
LMNL6326 and our GPR40 agonist discovery program; the timing of
initiation or nature of preclinical studies and clinical trials,
including the expected filing of a clinical trial authorization or
commencement of a Phase 1 clinical trial of LMNL6511 in the second
half of 2023; the contemplated potential therapeutic areas of our
product candidates, including IBD, NASH, liver or Eosinophilic
mediated diseases; the potential for our development programs to
address significant unmet medical needs. 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 and other geopolitical
tensions 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 opportunities; the successful and
timely initiation or completion of preclinical and clinical trials;
the ability 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; our ability to add new development opportunities to our
pipeline or to enter into strategic partnerships; our ability to
continue to comply with Nasdaq Listing Rule 5450(a)(1) to remain
listed on the Nasdaq Capital Market; our expected cash
runway and our ability to actively seek and close on
opportunities to monetize non-core assets or commercial
opportunities related to our assets and general changes in economic
conditions, including as a result of increased inflation, bank
failures and rising interest rates. 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,
2022, as well as other filings and reports Liminal
Biosciences' may make from time to time. 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.