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9 Meters Biopharma, Inc Receives Thorough QT Study Waiver by FDA for Larazotide Being Studied for Celiac Disease
Highlights larazotide's safety profile as a first-in-class gut-restricted, minimally absorbed peptide being studied in Phase 3 for celiac disease
The FDA requires most new chemical entities to be subjected to a randomized dedicated electrocardiogram trial involving normal volunteers, termed a thorough QT (TQT) study.1 "QT" refers to a specific time interval in the series of electric signals governing the heartbeat, in which the heart's electrical system repolarizes , or ‘recharges', after each beat.2
The purpose of TQT studies is to determine if novel agents under investigation demonstrate an abnormal effect on cardiac function with respect to the QT interval, which would warrant further safety analyses during the already rigorous path towards commercializing novel products in
Larazotide acetate was assessed in multiple pre-clinical, Phase 1 and Phase 2 studies in healthy subjects and celiac patients that include higher doses than the proposed highest dose currently in clinical development. In those studies, neither larazotide acetate nor its metabolites were detected in human serum using highly sensitive assays, resulting in the decision by the FDA to grant a waiver of a TQT study.
9 Meters is currently conducting a Phase 3 trial evaluating larazotide acetate in patients with non-responsive celiac disease, a severe variant of celiac disease in which patients experience gastrointestinal symptoms despite adherence to a gluten-free diet. Larazotide represents the only Phase 3-stage therapeutic in development for celiac disease, with the trial's interim analysis expected in the second half of 2021.
About Celiac Disease
Celiac disease affects approximately 3 million people in
About Larazotide Acetate
In celiac disease, larazotide is the only drug which has successfully met its primary endpoint with statistical significance in a Phase 2b efficacy clinical trial (342 patients). Nearly 600 subjects have been exposed to larazotide in clinical trials, and a safety profile comparable to placebo has been demonstrated. Larazotide has received Fast Track designation from the FDA and is currently enrolling patients in late-stage clinical development for celiac disease.
For more information, please visit www.9meters.com.
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 proposed Merger and the
- Overview of the ICH E14 Guideline & Its Implementation Within FDA: https://www.fda.gov/media/104642/download
- Heart Rhythm Society Patient Resources Page: https://www.upbeat.org/the-normal-heart/electrical-system
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