- The company plans to add another study arm to its ongoing Phase 2b OPTION 2 clinical study which currently tests delayed release capsules
- If it receives FDA approval, AzurRx would be able to identify the optimal delivery method for its drug candidate MS1819 without significant extra costs or delays
- Enrollment in this arm of the study could begin as early as December 2020
AzurRx BioPharma (NASDAQ: AZRX), a clinical-stage biopharmaceutical company specializing in the development of non-systemic, recombinant therapies for gastrointestinal diseases, has submitted a protocol amendment request to the U.S. Food and Drug Administration that would allow it to test immediate release capsules of its exocrine pancreatic insufficiency drug candidate MS1819.
According to a company press release, if the amendment is approved, AzurRx would modify its current Phase 2b OPTION 2 trial of MS1819 in cystic fibrosis patients to add a study arm that…
NOTE TO INVESTORS: The latest news and updates relating to AZRX are available in the company’s newsroom at https://ibn.fm/AZRX
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