NetworkNewsBreaks – AzurRx BioPharma Inc. (NASDA
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Posted On: 12/22/2020 3:07:08 PM
NetworkNewsBreaks – AzurRx BioPharma Inc. (NASDAQ: AZRX) Aims to Identify Best Delivery Method for Lead Drug Candidate
AzurRx BioPharma (NASDAQ: AZRX), a clinical-stage biopharmaceutical company specializing in the development of non-systemic, recombinant therapies for gastrointestinal diseases, recently submitted a protocol amendment request to the U.S. Food and Drug Administration (“FDA”). Approval of the amendment will allow AzurRx to modify its current Phase 2b OPTION 2 trial of MS1819 in cystic fibrosis (“CF”) patients to add a study arm that uses immediate release capsules (https://nnw.fm/ADfpm). The existing study arm uses delayed release capsules, so the expansion will allow AzurRx to compare data from both arms to determine the best delivery method for its lead product, an exocrine pancreatic insufficiency drug candidate. An article discussing this quotes AzurRx Chief Medical Officer Dr. James Pennington, who stated, “As this trial progresses, we believe there may be significant clinical value in adding a study arm that uses our immediate release capsules. Our intention is to identify the optimal delivery method and potentially provide additional scientific support and optionality for MS1819.”
Please see full disclaimers on the NetworkNewsWire website applicable to all content provided by NNW, wherever published or re-published: http://NNW.fm/Disclaimer
AzurRx BioPharma (NASDAQ: AZRX), a clinical-stage biopharmaceutical company specializing in the development of non-systemic, recombinant therapies for gastrointestinal diseases, recently submitted a protocol amendment request to the U.S. Food and Drug Administration (“FDA”). Approval of the amendment will allow AzurRx to modify its current Phase 2b OPTION 2 trial of MS1819 in cystic fibrosis (“CF”) patients to add a study arm that uses immediate release capsules (https://nnw.fm/ADfpm). The existing study arm uses delayed release capsules, so the expansion will allow AzurRx to compare data from both arms to determine the best delivery method for its lead product, an exocrine pancreatic insufficiency drug candidate. An article discussing this quotes AzurRx Chief Medical Officer Dr. James Pennington, who stated, “As this trial progresses, we believe there may be significant clinical value in adding a study arm that uses our immediate release capsules. Our intention is to identify the optimal delivery method and potentially provide additional scientific support and optionality for MS1819.”
Please see full disclaimers on the NetworkNewsWire website applicable to all content provided by NNW, wherever published or re-published: http://NNW.fm/Disclaimer
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