SC403


  • Indication:
    Short Bowel Syndrome
  • Key ingredients:
    Ethyl Cervonate (DHAEE)
  • Packaging:
    Parenteral Liquid Formulation
  • Regulatory:
    Orphan Drugs
  • Status:
    Phase-2
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A phase-2 treatment for Short Bowel Syndrome (SBS) through a Proprietary Platform for Enhanced Absorption of Lipophilic Drugs.

SC403 with the Advanced Lipid Technologies™(ALT®) Platform is an investigational drug designed to treat Pediatric Short Bowel Syndrome through increased bioavailability, which may promote intestinal adaptation and reduce the requirements of parenteral nutrition.

Major Milestones

  • Preclinical studies completed
  • Supportive proof of mechanism in a validated animal model
  • U.S. Orphan Drug Designation granted June 2015
  • FDA pre-IND meeting held July 2015
  • IND filed October 2016
  • Pediatric Human Trial expected to start in Q4 2016

A Preclinical Study Demonstrates that Piglets Receiving SC403 Gained More Weight Faster than the Control Group

Trials and Timeline

  • 28 and 90 day juvenile rat toxicity – Complete
  • 90 day; up to 8 children with SBS, PK, safety & tolerability as endpoints
  • Expect to commence clinical trial in H2 2016