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Find Clinical Drug Pipeline Developments & Deals by AzurRx BioPharma

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            Lead Product(s): MS1819,Porcine enzyme replacement therapy

            Therapeutic Area: Endocrinology Product Name: MS1819

            Highest Development Status: Phase II Product Type: Large molecule

            Partner/Sponsor/Collaborator: Undisclosed

            Deal Size: $22.1 million Upfront Cash: Undisclosed

            Deal Type: Private Placement July 20, 2020

            Details:

            Private placement will be used to advance two Phase 2 clinical trials of MS1819 in patients with cystic fibrosis.

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            Lead Product(s): MS1819,Porcine enzyme replacement therapy

            Therapeutic Area: Endocrinology Product Name: Undisclosed

            Highest Development Status: Phase II Product Type: Large molecule

            Recipient: Creapharm

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Agreement May 07, 2020

            Details:

            Creapharm will package, label, and distribute AzurRx’s MS1819 clinical trial drug product for both the upcoming Phase 2b OPTION 2 Monotherapy and the ongoing Phase 2 Combination Therapy Programs.

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            Lead Product(s): MS1819

            Therapeutic Area: Genetic Disease Product Name: Undisclosed

            Highest Development Status: Phase II Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable April 29, 2020

            Details:

            The Phase 2 study is designed to investigate the safety, tolerability and efficacy of MS1819 using 2.2 and 4.4 gram doses in enteric capsules head-to-head against the current standard of care.

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            Lead Product(s): MS1819

            Therapeutic Area: Endocrinology Product Name: Undisclosed

            Highest Development Status: Phase II Product Type: Large molecule

            Recipient: Delpharm Group

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Agreement April 16, 2020

            Details:

            Under this 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.

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            Lead Product(s): MS1819,Porcine enzyme replacement therapy

            Therapeutic Area: Endocrinology Product Name: Undisclosed

            Highest Development Status: Phase II Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable February 18, 2020

            Details:

            The presentation showcases the results from a Phase 2, 2x2 cross-over trial to assess the safety and efficacy of MS1819 in Patients with Exocrine Pancreatic Insufficiency in Cystic Fibrosis.

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            Lead Product(s): MS1819,Pancreatic enzyme replacement therapy

            Therapeutic Area: Genetic Disease Product Name: Undisclosed

            Highest Development Status: Phase II Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable January 09, 2020

            Details:

            Initial data from the first five patients indicate positive trends for all primary and secondary safety and efficacy endpoints in AzurRx’s Phase 2 Clinical Study for MS1819-SD with standard PERT.