FDA-&-EMA-New-Drug Approvals(Mid-2020 Recap)-insert
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Find FDA Investigational New Drug (IND) Submissions for Gastroenterology

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            Lead Product(s): Protego-PD

            Therapeutic Area: Gastroenterology Product Name: Protego-PD

            Highest Development Status: IND Enabling Product Type: Large molecule

            Partner/Sponsor/Collaborator: National Institute of Health

            Deal Size: $1.7 million Upfront Cash: Undisclosed

            Deal Type: Funding July 08, 2020

            Details:

            This award will fund the potency and preclinical effectiveness milestones for an Investigational New Drug (IND) filing for Protego-PDTM, an orally delivered acellular biotherapeutic developed by Plakous from post-delivery placentas.

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            Lead Product(s): Recombinant bovine intestinal alkaline phosphatase

            Therapeutic Area: Gastroenterology Product Name: SYN-020

            Highest Development Status: IND Enabling Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable June 30, 2020

            Details:

            Under the IND application, the Company intends to conduct a Phase 1 single ascending dose study in healthy volunteers, designed to evaluate SYN-020 for safety, tolerability, and pharmacokinetic parameters.

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            Lead Product(s): SMP-100

            Therapeutic Area: Gastroenterology Product Name: Undisclosed

            Highest Development Status: IND Enabling Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable May 14, 2020

            Details:

            First randomized, double-blinded, placebo-controlled Phase I clinical trial to investigate the safety and pharmacokinetics after oral administration of SMP-100 in healthy volunteers.

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            Lead Product(s): Cellspan Esophageal Implant

            Therapeutic Area: Gastroenterology Product Name: Undisclosed

            Highest Development Status: IND Enabling Product Type: Undisclosed

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable March 20, 2020

            Details:

            The FDA notified the Company that it removed the clinical hold and that the Company may proceed with its study.

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            Lead Product(s): KAN-101

            Therapeutic Area: Gastroenterology Product Name: Undisclosed

            Highest Development Status: IND Enabling Product Type: Undisclosed

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable January 21, 2020

            Details:

            Anokion plans to initiate its multi-center Phase 1 study for KAN-101 in people with celiac disease in the first quarter of 2020.