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9 Meters Biopharma, Inc. Announces Issuance of Patent for Use of Larazotide in Acute Lung Injury (ALI) and Acute Respiratory Distress Syndrome (ARDS)
"The issuance of this patent by the USPTO validates the unique mechanistic profile of our novel first-in-class tight junction modulator currently in Phase 3 development for celiac disease," said
The granted 9 Meters' patent shows, in a dose dependent fashion, larazotide renormalizes abnormally increased permeability of pulmonary tissue containing cellular tight junctions, and treats the direct cause of ALI and ARDS which can lead to fluid buildup within affected areas of the lungs.1 In pre-clinical models, larazotide has been shown to improve ALI as measured by protein, cellular and inflammatory markers2, as well as suggest a protective effect in virally-challenged mice during infection, mitigating ALI by blunting pulmonary edema.3 Previous experiments have shown larazotide inhibits tight-junction rearrangement and prevents epithelial permeability triggered by gliadin, the antigen responsible for immunogenicity and symptoms in people with celiac disease.4
Furthermore, larazotide has been identified as a potential candidate in studies to target the main protease or Mpro also known as 3C-like protease of SARS-CoV-2, the virus responsible for COVID-19.5,6 Coupling this emerging data along with the molecule's known effects on epithelial and endothelial tight junctions, 9 Meters is evaluating potential next steps for future research to address the possible extended implications of larazotide for ALI/ARDS associated with COVID-19 for internal or out-licensing development.
For more information, please visit www.9meters.com or follow 9 Meters on Twitter and LinkedIn.
This press release includes forward-looking statements based upon the Company's current expectations. Forward-looking statements involve risks and uncertainties, and include, but are not limited to, the potential effects of the ongoing coronavirus outbreak and related mitigation efforts on the Company's clinical, financial and operational activities; the Company's continued listing on NASDAQ; expectations regarding future financings; the future operations of the Company; the nature, strategy and focus of the Company; the development and commercial potential and potential benefits of any product candidates of the Company; anticipated preclinical and clinical drug development activities and related timelines, including the expected timing for data and other clinical and preclinical results; the Company having sufficient resources to advance its pipeline; and any other statements that are not historical fact. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation: (i) uncertainties associated with the clinical development and regulatory approval of product candidates; (ii) risks related to the inability of the Company to obtain sufficient additional capital to continue to advance these product candidates and its preclinical programs; (iii) uncertainties in obtaining successful clinical results for product candidates and unexpected costs that may result therefrom; (iv) risks related to the failure to realize any value from product candidates and preclinical programs being developed and anticipated to be developed in light of inherent risks and difficulties involved in successfully bringing product candidates to market; (v) the impact of COVID-19 on our operations, clinical trials or proposed merger and future financings and (vi) risks associated with the possible failure to realize certain anticipated benefits of the Company's recent merger and the
- Diamond M, Peniston Feliciano HL, Sanghavi D, et al. Acute Respiratory Distress Syndrome (ARDS) [Updated 2020
Jul 2]. In: StatPearls Publishing; 2020 Jan. Available from: https://www.ncbi.nlm.nih.gov/books/NBK436002/
- Rittirsch D, Flierl MA, Nadeau BA, et al. Zonulin as prehaptoglobin2 regulates lung permeability and activates the complement system. Am J Physiol Lung Cell Mol Physiol. 2013;304(12):L863-L872. doi: 10.1152/ajplung.00196.2012
- Shirey KA, Lai W, Patel MC, et al. Novel strategies for targeting innate immune responses to influenza. Mucosal Immunol. 2016;9(5):1173-1182. doi: 10.1038/mi.2015.141
Shobha Gopalakrishnan, Malarvizhi Durai, Kelly Kitchens, et al. Larazotide acetate regulates epithelial tight junctions in vitro and in vivo. Peptides. Volume 35, Issue 1, 2012, Pages 86-94. doi: 10.1016/j.peptides.2012.02.015 Luca Pinzi, Annachiara Tinivella, Fabiana Caporuscioet al. Drug repurposing and polypharmacology to fight SARS-CoV-2 through the inhibition of the main protease, 06 May 2020. Preprint. doi: 10.21203/rs.3. rs-27222/v1
- Liu, Hao; Jiang, Tao; Liu, Wenlang; Zheng, Zheng (2020): Computational Evaluation of the COVID-19 3c-like Protease Inhibition Mechanism, and Drug Repurposing Screening. ChemRxiv. Preprint. doi: 10.26434/chemrxiv.12090426.v1
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