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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): 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.
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