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Landos Biopharma Announces Acceptance of Abstract on NX-13 Phase 1b Study in Ulcerative Colitis at 18th Annual Congress of the European Crohn’s and Colitis Organization

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Landos Biopharma is set to initiate its Phase 2 proof-of-concept clinical trial for the NLRX1 agonist NX-13 targeting Ulcerative Colitis in Q2 2023. An abstract detailing Phase 1b study results has been accepted for poster presentation at the ECCO Congress in March 2023. The trial aims to enhance treatment for moderate-to-severe UC patients, with topline data expected by Q4 2024. Landos focuses on developing innovative therapeutics for autoimmune diseases, holding a pipeline of promising drug candidates.

Positive
  • NX-13 abstract accepted for presentation at ECCO Congress, indicating recognition in the scientific community.
  • Phase 2 clinical trial for NX-13 is on track for initiation, suggesting strong pipeline momentum.
  • Topline data from the upcoming trial is anticipated by Q4 2024, providing a timeline for investors.
Negative
  • None.

Company Remains On-Track to Initiate Phase 2 Proof-of-Concept Clinical Trial in Second Quarter of 2023

NEW YORK, Jan. 11, 2023 (GLOBE NEWSWIRE) -- 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 that an abstract on its Phase 1b Study to evaluate safety, tolerability, pharmacokinetics and clinical efficacy of the Nucleotide-binding oligomerization domain, Leucine rich Repeat containing X1 (NLRX1) agonist NX-13 in Ulcerative Colitis (“UC”), was accepted for poster presentation by the 18th Congress of the European Crohn’s and Colitis Organization (“ECCO”).

“We are excited and appreciative that the ECCO Clinical Research Committee has selected Landos’ NX-13 abstract for poster presentation and look forward to continuing to advance this potential new treatment through the clinic,” noted Dr. Fabio Cataldi, Executive Vice-President & Chief Medical Officer at Landos. “Our team is working hard to advance the upcoming NX-13 Phase 2 proof-of-concept clinical trial. And with a strong data foundation, we are confident in our path forward and are excited about the potential of NX-13 to potentially transform the current treatment paradigm for moderate-to-severe UC patients.”

As previously announced, Landos is planning to conduct a Phase 2 proof-of-concept clinical trial for NX-13, which is expected to 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, and expects to report topline data from the trial by the fourth quarter of 2024.

“Improving the daily life of patients with IBD, including UC, has always been my ultimate goal,” said Professor Laurent Peyrin-Biroulet, President of ECCO and the lead author of the NX-13 abstract. “I believe potential new therapies like NX-13 will pave the path for the future in managing autoimmune diseases.”

ECCO is the largest forum for specialists in Inflammatory Bowel Disease (“IBD”) in the world. ECCO's mission is to improve the care of patients with IBD in all its aspects through international guidelines for practice, education, research, and collaboration.

The NX-13 abstract will be featured as a poster presentation at the annual ECCO Congress in Copenhagen from March 1 – March 4, 2023.

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 for regulatory approvals, other matters that could affect the availability or commercial potential of the Company’s product candidates 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 Contact
Patrick Truesdell, Principal Accounting Officer
Landos Biopharma
ir@landosbiopharma.com

Media Contact
Tanner Kaufman / Kara Sperry
Joele Frank, Wilkinson Brimmer Katcher
212-355-4449


FAQ

When will the Phase 2 trial for NX-13 begin?

The Phase 2 proof-of-concept clinical trial for NX-13 is expected to begin in the second quarter of 2023.

What is NX-13 being tested for?

NX-13 is being tested for its effectiveness in treating Ulcerative Colitis.

When will topline data from the NX-13 trial be reported?

Topline data from the NX-13 trial is expected to be reported by the fourth quarter of 2024.

What event will present the NX-13 study results?

The results of the NX-13 Phase 1b study will be presented at the ECCO Congress in Copenhagen from March 1 – 4, 2023.

What is Landos Biopharma's focus?

Landos Biopharma focuses on developing novel oral medicines for patients with autoimmune diseases.

Landos Biopharma, Inc.

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