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Completed Clinical Studies

MS1819 Research to Date Demonstrates Safety and Supports Efficacy

  Efficacy Safety/Toxicity
In vitro - Test meal assays
  • Tested both by classical biochemistry assays and test-meal
  • Conditions tested for MS1819 in comparison to PPEs and recombinant pancreatic lipases (pH range, length of fatty acids chains, activity in presence of bile salts, resistance to proteolysis by pepsin.
  • In test meal assay, MS1819 enzymatic activity is 133x and 224x more active than commercial PPEs at pH4 and 6
  • Not applicable
In vivo - Minipig Model
  • in vivo minipig EPI model demonstrated efficacy comparable to PPE
  • Absence of mutagenic potential
  • No toxicity up to 1g/kg/day in rats and 250 mg/kg/day in minipigs over 3 months
  • IgG against MS1819 can be detected in some animals (rats and minipigs) following exposure of MS1819 without detectable immunotoxicity
Flip 110 Phase IIa Clinical Study
  • Exploratory, randomized, double-blind, placebocontrolled, parallel clinical trial in 12 patients with CP or pancreatectomy and server EPI (historical steatorrhea >= 7g/24h), n = 12
  • MS1819 treatment effect demenstrated for the primary endpoint, steatorrhea
  • Secondary endpoints also supported the efficacy (i.e. coefficient of fat absorption (CFA), number of stools over 7 daysm stool weightm Bristol scale
  • No significant adverse events or SUSAR (Suspected Unexpected Serious Adverse Reactions)
  • Possible safety signals of constipation,
  • No rise in IgG anti-MS1819
  • No detection of MS1819 lipase