Latiglutenase: Prospective, Randomized, Double-Blind, Placebo-Controlled, Crossover Study in Symptomatic CD Patients

Clinical Trial
Phase 2b Safety & Efficacy Trial ClinicalTrials.gov: NCT04243551
Indication	#Patients
Celiac disease	120
Highlights
Solutions for Celiac™ is a clinical research study funded by the NIH (NIAID) that has been designed to assess the drink-based investigational medication latiglutenase and its ability to relieve common symptoms suffered by celiac disease patients after accidental gluten exposure in a real-world setting

Clinical Trial	Indication	#Patients	Highlights
Phase 2b Safety & Efficacy Trial ClinicalTrials.gov: NCT04243551	Celiac disease	120	Solutions for Celiac™ is a clinical research study funded by the NIH (NIAID) that has been designed to assess the drink-based investigational medication latiglutenase and its ability to relieve common symptoms suffered by celiac disease patients after accidental gluten exposure in a real-world setting

Adrulipase: Pursuing Parallel Monotherapy and Combination Therapy Pathways

Clinical Trial
Phase 2 Bridging Trial ClinicalTrials.gov: NCT05719311
Indication	#Patients
Cystic Fibrosis	13
Highlights
Open label, dose-titration study with new enteric microgranule formulation

Clinical Trial	Indication	#Patients	Highlights
Phase 2 Bridging Trial ClinicalTrials.gov: NCT05719311	Cystic Fibrosis	13	Open label, dose-titration study with new enteric microgranule formulation

Latiglutenase as a Treatment for Celiac Disease

Clinical Trial
Phase 2 Safety & Efficacy Trial ClinicalTrials.gov:NCTO3585478
Indication	#Patients
Celiac disease	79
Highlights
The CeliacShield Study™ is a clinical research study funded by the NIH (NCCIH) that assesses the ability of latiglutenase, an investigational drug, to protect the small intestine of celiac disease patients from damage caused by gluten exposure

Clinical Trial	Indication	#Patients	Highlights
Phase 2 Safety & Efficacy Trial ClinicalTrials.gov: NCTO3585478	Celiac disease	79	The CeliacShield Study™ is a clinical research study funded by the NIH (NCCIH) that assesses the ability of latiglutenase, an investigational drug, to protect the small intestine of celiac disease patients from damage caused by gluten exposure

Adrulipase: Pursuing Parallel Monotherapy and Combination Therapy Pathways

Clinical Trial
Phase 2 Dose Escalation Trial ClinicalTrials.gov: NCT04375878
Indication	#Patients
Cystic Fibrosis	27
Highlights
Open label, crossover study comparing FW-EPI to commercial PERTs Study 2.2 mg/day and 4.4. mg/day using enteric capsules for gastric protection
Clinical Trial
Phase 2 Combination Therapy Dose Escalation Trial ClinicalTrials.gov: NCT04302662
Indication	#Patients
Cystic Fibrosis Severe EPI	20
Highlights
Add Adrulipase to commercial PERT to improve patient control Primary endpoint to increase CFA from baseline value of <80% on PERT alone

Clinical Trial	Indication	#Patients	Highlights
Phase 2 Dose Escalation Trial ClinicalTrials.gov: NCT04375878	Cystic Fibrosis	27	Open label, crossover study comparing FW-EPI to commercial PERTs Study 2.2 mg/day and 4.4. mg/day using enteric capsules for gastric protection
Phase 2 Combination Therapy Dose Escalation Trial ClinicalTrials.gov: NCT04302662	Cystic Fibrosis Severe EPI	20	Add Adrulipase to commercial PERT to improve patient control Primary endpoint to increase CFA from baseline value of <80% on PERT alone

Niclosamide: Pursuing Anti-Viral GI Pathways

Clinical Trial
Phase 2 Safety and Efficacy Trial ClinicalTrials.gov: NCT04858425
Indication	#Patients
COVID-19 GI Infections	166
Highlights
First study towards repurposing potent anti-viral therapeutic to treat gastrointestinal infections of COVID-19 Proprietary oral formulation of niclosamide

Clinical Trial	Indication	#Patients	Highlights
Phase 2 Safety and Efficacy Trial ClinicalTrials.gov: NCT04858425	COVID-19 GI Infections	166	First study towards repurposing potent anti-viral therapeutic to treat gastrointestinal infections of COVID-19 Proprietary oral formulation of niclosamide

Niclosamide: Pursuing Anti-Inflammatory GI Pathways