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9 Meters Biopharma Announces Publication of Data on Larazotide for the Treatment of Multisystem Inflammatory Syndrome in Children (MIS-C)

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RALEIGH, NC / ACCESSWIRE / February 25, 2022 / 9 Meters Biopharma, Inc. (NASDAQ:NMTR), a clinical-stage company pioneering novel treatments for people with rare or debilitating digestive diseases, announced the publication of encouraging data in the journal Critical Care Explorations, accessible online here, on the use of larazotide to treat pediatric patients with multisystem inflammatory syndrome in children (MIS-C) resulting from COVID-19. MIS-C is a rare but severe and potentially life-threatening condition that usually develops in children weeks to months after they have experienced a mild or even asymptomatic case of COVID-19.

The four patients in the published case series were children ages 3 to 17 being treated for MIS-C at MassGeneral Hospital for Children. All four children who received larazotide experienced significantly faster resolution of gastrointestinal symptoms; in addition, their hospital stays were numerically slightly shorter on average compared to children who did not receive larazotide. Additionally, serum levels of the SARS-CoV-2 spike protein, which constitutes a viral particle associated with multisystem inflammation, diminished to undetectable levels within one day on average in children treated with larazotide, versus ten days for children not treated with larazotide. Larazotide was well tolerated with no adverse effects reported.

An ongoing randomized, double-blind, placebo-controlled Phase 2a study (NCT05022303) of larazotide for the treatment of MIS-C led by Lael Yonker, M.D., pediatric pulmonologist and director of the Cystic Fibrosis Center at MassGeneral Hospital for Children, is currently underway. The study is the product of a collaboration between 9 Meters and the European Biomedical Research Institute of Salerno, Italy (EBRIS).

Under the terms of the collaboration between 9 Meters and EBRIS, 9 Meters will supply larazotide for the purposes of the clinical study, and EBRIS will be responsible for conducting the Phase 2a trial inclusive of all associated clinical costs.

About 9 Meters Biopharma
9 Meters Biopharma is a clinical-stage company pioneering novel treatments for people with rare digestive diseases, GI conditions with unmet needs, and debilitating disorders in which the biology of the gut is a contributing factor. The Company is advancing vurolenatide, a proprietary Phase 2 long-acting GLP-1 agonist, for short bowel syndrome (SBS); larazotide, a Phase 3 tight junction regulator in non-responsive celiac disease; and several near clinical-stage assets.

For more information please visit www.9meters.com or follow 9 Meters on Twitter and LinkedIn.

Forward-Looking Statements
This press release includes forward-looking statements based upon the Company's current expectations. Forward-looking statements include, but are not limited to, statements that express our intentions, beliefs, expectations, strategies, predictions, anticipated milestones and any other statements relating to our future activities or other future events or conditions. These statements are based on current expectations, estimates and projections about our business based, in part, on assumptions made by management. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation: reliance on research and development partners; intellectual property risks; uncertainties associated with the clinical development and regulatory approval of product candidates; uncertainties in obtaining successful clinical results for product candidates and unexpected costs that may result therefrom; 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; the impact of COVID-19 on our operations, enrollment in and timing of clinical trials; risks related to the inability of the Company to obtain sufficient additional capital to continue to advance these product candidates and its preclinical programs; reliance on collaborators; and risks associated with acquiring and developing additional compounds. These and other risks and uncertainties are more fully described in periodic filings with the SEC, including the factors described in the section entitled "Risk Factors" in the Company's Annual Report on Form 10-K for the year ended December 31, 2020, Form 10-Q for the quarter ended September 30, 2021, and in other filings that the Company has made and future filings the Company will make with the SEC. You should not place undue reliance on these forward-looking statements, which are made only as of the date hereof or as of the dates indicated in the forward-looking statements. The Company expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in its expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based.

Corporate Contact
Al Medwar
SVP, Investor Relations & Corporate Communications
9 Meters Biopharma, Inc.

Media Contact
Veronica Eames
LifeSci Communications, LLC

SOURCE: 9 Meters Biopharma

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