AzurRx Announces Manufacturing Agreement with Delpharm for MS1819 Clinical Drug Product
AzurRx BioPharma, Inc. (AZRX)
Last azurrx biopharma, inc. earnings: 11/14 04:31 pm
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Source: GlobeNewswire
NEW YORK, April 16, 2020 (GLOBE NEWSWIRE) -- AzurRx BioPharma, Inc. (NASDAQ:AZRX) (“AzurRx” or the “Company”), a company specializing in the development of non-systemic, recombinant therapies for gastrointestinal diseases, today announced that it has entered into a manufacturing agreement with Delpharm (“Delpharm”), a leading contract development manufacturing organization (CDMO), for the clinical drug product supply of its MS1819 therapy for exocrine pancreatic insufficiency (EPI). Under the terms of the agreement, Delpharm will manufacture AzurRx’s MS1819 cGMP batch that will be used in the Phase 2b OPTION 2 Clinical Trial for the treatment of EPI in patients with Cystic Fibrosis (CF). As preparation for the cGMP batch, the drug product manufacturing process was transferred to Delpharm and they have successfully produced a non-GMP batch. This marks the first time in which MS1819 has been manufactured with enteric capsules, which will be used in the OPTION 2 Trial to deliver
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