Gastroenterology | IND Enabling Drugs

Jaguar Health

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Jaguar Health Announces Activation of Investigational New Drug for Crofelemer (Mytesi) for Prophylaxis and Symptomatic Relief of Cancer Ther...

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)).

Synthetic Biologics

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Synthetic Biologics Announces FDA Clearance of Investigational New Drug Application for SYN-020 Intestinal Alkaline Phosphatase (IAP)

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.

Plakous Therapeutics

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Plakous Therapeutics Awarded $1.7 Million Fast-Track SBIR Grant from NIH to Develop Therapies for Necrotizing Enterocolitis

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.

Synthetic Biologics

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Synthetic Biologics Seeks US FDA Approval to Initiate Phase 1 Study of SYN-020 Intestinal Alkaline Phosphatase

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.

Xiling Lab

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CHINA China

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Scimount Announces FDA Approval of SMP-100's IND Application for the Treatment of Irritable Bowel Syndrome

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.