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