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AzurRx BioPharma (NASDAQ: AZRX) announced the initiation of its Phase 2b OPTION 2 clinical trial for MS1819, targeting cystic fibrosis (CF) patients with exocrine pancreatic insufficiency (EPI). Three clinical trial sites in the U.S. are now activated, with the first patient screening underway. The trial aims to assess the safety and efficacy of MS1819 against the current porcine enzyme replacement therapy, with top-line data expected in Q1 2021. The study includes approximately 30 patients and focuses on the coefficient of fat absorption as the primary efficacy endpoint.
AzurRx BioPharma (NASDAQ: AZRX) announced a private placement on July 16, 2020, yielding approximately $15.2 million in gross cash proceeds. The funds will support two Phase 2 clinical trials for MS1819, targeting cystic fibrosis patients. The deal includes an exchange of $6.9 million in outstanding promissory notes to strengthen the company’s balance sheet. Investors will need to approve the issuance of shares related to this private placement at the annual stockholder meeting scheduled for September 11, 2020.
AzurRx BioPharma, Inc. (NASDAQ: AZRX) announced a partnership with Creapharm Clinical Supplies for the packaging, labeling, and distribution of MS1819, a therapy for exocrine pancreatic insufficiency (EPI). This collaboration covers the upcoming Phase 2b OPTION 2 Monotherapy trial and the ongoing Phase 2 Combination Therapy trial across multiple European countries and the U.S. The partnership ensures a stable supply chain amid COVID-19 disruptions, confirming the continuity of clinical trials aimed at treating EPI in cystic fibrosis patients.
