Landos Biopharma, Inc. (NASDAQ: LABP) (“Landos” or the “Company”),
a clinical-stage biopharmaceutical company developing novel, oral
medicines for patients with autoimmune diseases, today announced a
comprehensive update on its future clinical development plans.
The Landos leadership team and Board of Directors have conducted
an in-depth review of the Company’s pipeline and overall
development plans to ensure that it is pursuing the most promising
therapies and target indications. Following the review of Landos’
three clinical stage programs – NX-13, Omilancor and LABP-104 – as
well as its four pre-clinical assets, Landos will be focused on
advancing NX-13, a novel, oral, gut-selective NLRX1 agonist in
development as a once-daily treatment for Ulcerative Colitis
(“UC”), including into an upcoming Phase 2 proof-of-concept
clinical trial.
“After thorough analysis and careful consideration, we are
confident that focusing our resources toward NX-13’s clinical
development has the potential to deliver the most value for Landos
and our shareholders,” said Gregory Oakes, President and Chief
Executive Officer of Landos. “Given the strong clinical data we saw
in prior NX-13 trials and our anticipated timeline for the Phase 2
trial, we believe that advancing its development is the right path
forward. NX-13, with its unique mechanism of action (“MOA”),
favorable safety profile, once-daily dosing, and promising early
clinical data, could potentially transform the current treatment
paradigm with earlier utilization in moderate-to-severe UC for
patients who are either failing or starting to lose efficacy on
conventional therapies like 5-ASAs or steroids.
Following the positive read-out of the NX-13 Phase 1b trial, we
have been finalizing the design for a Phase 2 proof-of-concept
clinical trial. Our goal is to generate as much meaningful data as
possible, as quickly as possible, to build on our already
impressive data foundation. We expect that the NX-13 Phase 2 trial
will have two active arms and will be blinded, placebo-controlled,
and statistically powered. We have already completed a series of
startup activities and are on track for first site activation and
patient enrollment in the second quarter of 2023. We look forward
to sharing our progress and expect to report topline data by the
fourth quarter of 2024.”
Given the strong foundation of data across its broader pipeline,
Landos believes Omilancor, LABP-104 and its novel preclinical
programs are poised for partnering and continued clinical
development in the future. Landos will continue to explore
collaborations and other arrangements that would provide additional
resources and/or capabilities to advance these promising programs
and create value for shareholders.
“Our goal is to evolve Landos from a discovery-based
organization into an immunology development powerhouse. We are
focused on the successful advancement of our innovative pipeline of
multiple pathways and programs with novel MOAs. We continue to see
significant optionality for our broader pipeline, including
Omilancor for UC, Crohn’s Disease (“CD”), Eosinophilic Esophagitis,
Psoriasis, and Atopic Dermatitis; LABP-104 for Systemic Lupus
Erythematosus (“SLE”) and Rheumatoid Arthritis (“RA”); as well our
preclinical programs: LABP-66 for the treatment of Multiple
Sclerosis (“MS”), Alzheimer's Disease, and other debilitating
central nervous system (“CNS”) diseases; LABP-73 for Respiratory
Inflammatory disease; LABP-69 for RA and Diabetic Nephropathy; and
LABP-111 for Nonalcoholic Steatohepatitis (“NASH”) and Diabetes. We
believe that potential partners, key opinion leaders, academics,
and others are excited about these programs, and we will continue
to engage with them to explore opportunities that would create
long-term value for our shareholders. As we look ahead, we believe
these programs have significant optionality for continued
development in the future,” continued Mr. Oakes.
Adding Key Talent and Capabilities
Landos has also been selectively enhancing its leadership team,
adding key talent and capabilities to help position the Company for
continued success as it advances NX-13 towards a Phase 2 proof-of-
concept trial. Landos has added experts with significant clinical
drug development expertise in the immunology space, including the
appointment of Fabio Cataldi, MD, as Executive Vice President &
Chief Medical Officer in September 2022. Dr. Cataldi brings more
than twenty years of experience to Landos in the successful
development of innovative therapies, including research expertise
in gastroenterology and immunology, particularly in UC.
Partnership with LianBio
As announced in 2021, Landos entered into an exclusive
collaboration and license agreement with LianBio for the
development and commercialization of NX-13 and Omilancor in Greater
China, including mainland China, Hong Kong, Taiwan, and Macau, as
well as other select Asian markets. Of note, the Company continues
to maintain rights to Japan, which Landos believes is a significant
and growing market opportunity.
Clinical Stage Programs
NX-13NX-13 is a novel, oral, gut-selective
NLRX1 agonist in development for the once-daily treatment of
UC.
- Landos announced top-line results from its NX-13 Phase 1b trial
in UC patients in August 2022. The data showed favorable safety and
tolerability profiles across a range of doses, as well as signals
of clinical improvement as soon as two weeks in patients’ symptoms
and four weeks by endoscopy in exploratory endpoints. This early
signal, as well as the data from long-term toxicology studies,
support the potential of NX-13 as an important new treatment for
UC.
- Landos is continuing an in-depth analysis of the clinical,
pharmacokinetic (“PK”), and pharmacodynamic (“PD”) data for NX-13.
A preliminary analysis demonstrated promising signals of both
target engagement and molecular dose response among the 250mg and
500mg IR doses.
- Landos will be conducting a Phase 2 proof-of-concept clinical
trial for NX-13, which will be dose ranging, blinded,
placebo-controlled, and statistically powered.
- The Company is on track for first site activation and patient
enrollment for the NX-13 Phase 2 trial in the second quarter of
2023. The Company expects to report topline data from the trial by
the fourth quarter of 2024.
- In addition to UC, the Company believes NX-13 has the potential
to treat CD.
OmilancorOmilancor is a novel, oral, LANCL2
agonist in development for the once-daily treatment of UC.
- Landos has completed a global Phase 2 trial in mild-to-moderate
UC, which confirmed the safety and tolerability characteristics
observed in the Phase 1a trial. While this study showed a clinical
remission rate of over 30%, it did not reach statistical
significance due to a higher-than-expected placebo remission rate
of over 20%.
- A pre-specified disease severity analysis, however indicated
clinical efficacy in more severe UC patients, and that an enhanced
formulation may further improve Omilancor efficacy in future
trials.
- The Company is evaluating whether an enhanced formulation may
improve absorption and local bioavailability of Omilancor to the
colonic mucosa, and potentially increasing durable efficacy.
LABP-104LABP-104 is a novel, oral, systemically
distributed LANCL2 agonist in development for the once-daily
treatment of SLE and/or RA.
- Today, Landos announced that it recently completed a successful
Phase 1a clinical trial of LABP-104, which was well-tolerated in
healthy volunteers and did not result in any serious adverse
events.
- The Phase 1a clinical trial results for LABP-104 support its
potential as a treatment for SLE and/or RA, and the Company is
evaluating whether future formulations may provide enhanced
absorption characteristics to maximize drug effects.
Pre-Clinical Programs
The Company also has four promising, novel pre-clinical programs
in its portfolio, including:
- LABP-66: A novel NLRX1 agonist in development
for the treatment of MS, Alzheimer's Disease, and other
debilitating CNS diseases.
- As announced in August 2021, Landos entered into a research
collaboration with Dr. Peter Calabresi, Director of the Multiple
Sclerosis Center and Professor of Neurology at Johns Hopkins
University School of Medicine. The research is funded by the
National Institute of Health and is focused on further validating
the NLRX1 immunometabolic pathway in MS. Since inception, the study
has progressed from in vitro analysis of the role of NLRX1
activation in glial cells to mouse studies to validate and expand
the initial findings in preclinical models of MS. Dr. Calabresi’s
team recently presented their data at the National MS Society
Tykeson Fellows Conference and the Race to Erase MS Symposium.
- LABP-73: A novel NLRX1 agonist in development
for the treatment of Asthma and Chronic Obstructive Pulmonary
Disease.
- LABP-69: A novel PLXCD2 agonist in development
for the treatment of RA and Diabetic Nephropathy. LABP-69 aims to
increase IL-10 secretion and down regulate pro-inflammatory signals
and angiogenesis, supporting its potential as a novel therapy for
RA and Diabetic Nephropathy.
- LABP-111: A novel LANCL2 agonist in
development for the treatment of NASH and Diabetes.
Financial Update
Today, Landos also separately announced that it has secured a
$16.7 million investment at market price, from its largest
shareholder, Perceptive Advisors. With this additional funding, the
Company expects to have sufficient cash, cash equivalents and
marketable securities to fund its planned operations into the first
half of 2025.
“We believe this successful financing underscores our
shareholders’ confidence and excitement in our path forward and the
significant value that we expect to deliver as we advance NX-13. We
look forward to executing on our strategic plan, leveraging the
strength of Landos’ assets to drive value for patients and
shareholders alike,” said Mr. Oakes.
Consistent with its enhanced focus, the Company has actively
reprioritized Landos’ key initiatives and taken steps to right-size
its cost structure. The Company has realized substantial operating
cost efficiencies over the past year. As the Company transitions
from the clinical conduct and close-out activities of previous
trials, to finalizing the design and launch of the new NX-13 trial,
Landos expects its cash requirements to remain relatively constant
in future periods.
Corporate Update Conference Call
The Company will host a live webcast to provide a comprehensive
update on Landos’ clinical development plans at 8:00 AM ET
today.
The webcast can be accessed through the Company’s investor
relations website at https://ir.landosbiopharma.com/, or by dialing
800-225-9448 (Toll Free) or 203-518-9708 (International). For those
who cannot listen to the live webcast, a replay will be made
available on the Company’s investor relations website.
About Landos Biopharma Landos Biopharma is a
clinical stage biopharmaceutical company focused on the development
of first-in-class therapeutics for patients with autoimmune
disease. The Company’s mission is to create safer and more
effective treatments that address the therapeutic gap in the
current treatment paradigm.
Landos has a portfolio of three novel targets anchoring
libraries of immunometabolic modulation pathways, including seven
potentially first-in-class, once-daily therapies targeting 14
indications in the immunology space. This includes our three
clinical stage programs: NX-13 for Ulcerative Colitis and Crohn’s
Disease; Omilancor for Ulcerative Colitis, Crohn’s Disease and
Eosinophilic Esophagitis; and LABP-104 for Systemic Lupus
Erythematosus and Rheumatoid Arthritis
The Company is currently focused on advancing the clinical
development of NX-13 in Ulcerative Colitis.
For more information, please visit www.landosbiopharma.com.
Cautionary Note on Forward-Looking Statements
Statements in this press release about future expectations, plans
and prospects for Landos Biopharma, Inc. (the “Company”), including
statements about the Company’s strategy, clinical development and
regulatory plans for its product candidates and other statements
containing the words “anticipate”, “plan”, “expect”, “may”, “will”,
“could”, “believe”, “look forward”, “potential”, the negatives
thereof, variations thereon and similar expressions, or any
discussions of strategy constitute forward-looking statements.
Actual results may differ materially from those indicated by such
forward-looking statements as a result of various important
factors, including: the uncertainties inherent in the initiation
and enrollment of future clinical trials, including the planned
Phase 2 trial of NX-13, availability and timing of data from
ongoing clinical trials, expectations regarding the reformulation
for Omilancor, expectations for regulatory approvals, other matters
that could affect the availability or commercial potential of the
Company’s product candidates, the Company’s anticipated cash
runway, potential partnering opportunities and other similar risks.
Risks regarding the Company’s business are described in detail in
its Securities and Exchange Commission (“SEC”) filings, including
in its Annual Reports on Form 10-K and Quarterly Reports on Form
10-Q, which are available on the SEC’s website at www.sec.gov.
Additional information will be made available in other filings that
the Company makes from time to time with the SEC. Such risks may be
amplified by the impacts of the COVID-19 pandemic. In addition, the
forward-looking statements included in this press release represent
the Company’s views only as of the date hereof. The Company
anticipates that subsequent events and developments will cause the
Company’s views to change. However, while the Company may elect to
update these forward-looking statements at some point in the
future, the Company specifically disclaims any obligation to do so,
except as may be required by law. These forward-looking statements
should not be relied upon as representing the Company’s views as of
any date subsequent to the date hereof.
Investor ContactPatrick Truesdell, Principal
Accounting OfficerLandos Biopharmair@landosbiopharma.com
Media ContactTanner Kaufman / Kara SperryJoele
Frank, Wilkinson Brimmer Katcher212-355-4449
Landos Biopharma (NASDAQ:LABP)
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