RALEIGH, NC and SANTA ROSA, CA / ACCESSWIRE / April 20, 2022 / 9 Meters Biopharma, Inc. (NASDAQ:NMTR), a clinical-stage company pioneering novel treatments for people with rare or debilitating digestive diseases, and Celiac.com, a news, information, and support website for those on a gluten-free diet due to celiac disease or gluten sensitivity announced today a collaboration to further support clinical trial enrollment in 9 Meters' Phase 3 study known as CeDLara, for the drug candidate larazotide for celiac disease.
9 Meters' CeDLara study is a Phase 3 randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of 9 Meters' larazotide for adult patients with at least a six-month history of celiac disease who continue to experience gastrointestinal symptoms despite maintaining a gluten-free diet. An interim analysis to confirm study sample size assumptions is anticipated to be completed in early June. Additional details on the trial can be found at celiac-study.com.
"Celiac.com has been closely following the development of larazotide and is excited to partner with 9 Meters to help recruit participants for its Phase 3 study. We hope that the results of this study will soon lead to the first FDA-approved prescription treatment for those with celiac disease and close the gap for those still struggling to recover from their celiac disease diagnosis," said Scott Adams, CEO of Celiac.com. "It is also our hope that Celiac.com's community will gain a treatment option that is currently unavailable, as a large percentage of people with celiac disease face ongoing symptoms even after they go on a gluten-free diet."
Patrick Griffin, M.D., FACP and Chief Medical Officer of 9 Meters added, "We are very appreciative of the collaboration with Celiac.com and the assistance in reaching individuals with celiac disease who may be candidates for inclusion in our Phase 3 clinical study. We look forward to completing this important trial in hopes of providing a treatment option for those with celiac disease who continue to experience symptoms despite maintaining a gluten-free diet."
Celiac disease is an autoimmune gastrointestinal disease characterized by an inflammatory response to dietary gluten, causing abdominal pain and gas that are often severe and life-altering. Adherence to a gluten-free diet is currently the only therapeutic option for people living with celiac disease, and it is insufficient for asymptomatic living in many cases due to unintentional consumption of trace amounts of gluten found in many foods and cosmetic products. Larazotide, 9 Meters' oral, gut-restricted tight-junction regulator is the only Phase 3 therapeutic in development for celiac disease. Larazotide is designed to mitigate the life-altering symptoms by preventing gluten breakdown from leaving the intestine and causing an inflammatory response when small amounts of gluten are consumed. 9 Meters aims to introduce larazotide as an adjunctive therapy in tandem with a gluten-free diet in adults with celiac disease to restore tight junctions between intestinal cells, mitigate gliadin "leakage," and thus minimize symptoms.
About 9 Meters Biopharma
9 Meters Biopharma, Inc., 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. 9 Meters 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.
About Celiac.com
Since 1995 Celiac.com has provided news, information, and support for those on a gluten-free diet due to celiac disease or gluten sensitivity. Celiac.com does not sell any products and is 100% advertiser supported. The information on our site is not intended to replace the advice of a doctor or trained medical professional.
Celiac.com was created by Scott Adams shortly after he was diagnosed with celiac disease, and it was the first site on the Internet dedicated to the disease. The site is dedicated to summarizing the latest research and news about celiac disease, and for over 20 years its expertly moderatedforums have provided crucial support to millions of people in the celiac community.
Forward-Looking Statements
This press release includes forward-looking statements based upon 9 Meters' 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: uncertainties associated with the clinical development and regulatory approval of product candidates; reliance on collaborators; reliance on research and development partners; 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; intellectual property risks; the impact of COVID-19 on our operations, enrollment in and timing of clinical trials; risks related to the inability of 9 Meters to obtain sufficient additional capital to continue to advance these product candidates and its preclinical programs, including in light of current stock market conditions; risk of delisting from Nasdaq; risks related to cybersecurity and data privacy; 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 9 Meters' Annual Report on Form 10-K for the year ended December 31, 2021, and in other filings that 9 Meters has made and future filings 9 Meters 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. 9 Meters 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.
9 Meters Contacts
Al Medwar
SVP, Investor Relations & Corporate Communications
9 Meters Biopharma, Inc.
investor-relations@9meters.com
Veronica Eames
LifeSci Communications, LLC
veames@lifescicomms.com
203-942-4626
Celiac.com Contact
Scott Adams
CEO
www.celiac.com
info@celiac.com
SOURCE: 9 Meters Biopharma, Inc., and Celiac.com
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