Completed Clinical Trials

 Clinical Trial Indication #Patients Efficacy Safety/Toxicity
Phase 2a Bridging Dose Safety Trial

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Cystic Fibrosis 32
  • A Phase 2, Open-Label, Multicenter, 2x2 Crossover Trial to assess the Safety and Efficacy of MS1819-SD in Patients with Exocrine Pancreatic Insufficiency due to Cystic Fibrosis
  • Six-week study: patients randomized to daily dose of PERT or 2.2g daily dose of MS1819, with cross-over after 3 weeks
  • CFA: MS1819 56%* vs. PERT 86%
  • CNA: MS1819 93% vs. PERT 97%
  • No significant adverse events or SUSAR (Suspected Unexpected Serious Adverse Reactions)
ClinicalTrials.gov:NCT03746483
Phase 2 Dose Escalation Trial 



chronic pancreatitis



Chronic Pancreatitis & Pancreatectomy 11
  • A multicenter, randomized, double-blind, placebo-controlled, Phase IIb study to assess the efficacy and safety of a Yarrowia lipolytica lipase (MS1819) for the management of exocrine pancreatic insufficiency due to chronic pancreatitis and/or distal pancreatectomy
  • Following wash-out, patients received 280 mg, 560mg, 1120mg and 2240mg daily doses of MS1819 over a120 day period
  • Statistically significant 21.8% CFA improvement at highest dose of 2.2 g (Per Protocol Analysis)
  • Statistically Significant and Clinically Meaningful Improvements
    • # Bowel Movements
    • Stool Consistency
    • Steatorrhea
  • No significant adverse events or SUSAR (Suspected Unexpected Serious Adverse Reactions)
ClinicalTrials.gov:NCT03481803
Phase 1 FLIP 110 Safety Trial Chronic Pancreatitis & Pancreatectomy 12
  • Exploratory, randomized, double-blind, placebo controlled, parallel clinical trial in 12 patients with CP or pancreatectomy and severe EPI (historical steatorrhea >= 7g/24h
  • MS1819 treatment effect demonstrated for the primary endpoint and steatorrhea
  • Secondary endpoints also supported the efficacy (i.e. coefficient of fat absorption (CFA), mean number of stools over 7 days, mean stool weight, and mean stool consistency using the 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