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Find Clinical Drug Development Pipelines & Deals | PipelineProspector

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            Lead Product(s): PRA023

            Therapeutic Area: Gastroenterology Product Name: PRA023

            Highest Development Status: IND Enabling Product Type: Large molecule

            Partner/Sponsor/Collaborator: Eventide Asset Management

            Deal Size: $130.0 million Upfront Cash: Undisclosed

            Deal Type: Financing November 09, 2020

            Details:

            The capital raised will enable to advance the clinical development of its lead antibody program targeting TL1A-associated IBD and grow its emerging pipeline of precision medicine programs designed to deliver life-changing outcomes for patients.

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            Lead Product(s): Maltosyl-isomaltooligosaccharide

            Therapeutic Area: Gastroenterology Product Name: MIMO

            Highest Development Status: IND Enabling Product Type: Large molecule

            Partner/Sponsor/Collaborator: Virginia Catalyst

            Deal Size: $0.8 million Upfront Cash: Undisclosed

            Deal Type: Funding October 26, 2020

            Details:

            ISOThrive is studying maltosyl-isomaltooligosaccharide for the treatment of GERD, and potential for reducing risk of Barrett's Esophagus and esophageal adenocarcinoma in collaboration with Eastern VA Medical School, University of VA and George Mason University.

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            Lead Product(s): SYNB8802

            Therapeutic Area: Gastroenterology Product Name: SYNB8802

            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 October 22, 2020

            Details:

            SYNB8802 is moving into human clinical studies where it will be assessed for safety and tolerability, strain kinetics, changes in plasma and urine biomarkers of strain activity, and the potential to reduce urinary oxalate.

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            Lead Product(s): Crofelemer

            Therapeutic Area: Gastroenterology Product Name: Mytesi

            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 August 06, 2020

            Details:

            U.S. Food and Drug Administration (FDA) for the use of crofelemer (Mytesi®) for prophylaxis and symptomatic relief of diarrhea in adult patients with solid tumors receiving targeted therapy with or without standard chemotherapy ("cancer therapy‑related diarrhea" (CTD)).

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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 July 30, 2020

            Details:

            Synthetic Biologics intends to conduct a Phase 1 single ascending dose study in healthy volunteers, designed to evaluate SYN-020 for safety, tolerability, and pharmacokinetic parameters, during the first quarter of 2021.

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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 Institutes 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): 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.