Alba Therapeutics Corporation announces that it has completed patient enrollment and dosing in the Phase II clinical trial of drug AT-1001 for the treatment of celiac disease
BALTIMORE, Maryland 03/08/2007 – Alba Therapeutics Corporation today announced that it has completed patient enrollment and dosing in the Phase IIa clinical trial to determine the dosage of the drug AT-1001 . This drug is administered orally, it is a zonulin receptor antagonist and is a potential drug for the treatment of celiac disease (CD). This randomized, double-blind, placebo-controlled clinical trial is designed to evaluate the safety, efficacy and tolerability of the drug AT-1001 in 86 subjects with CD performing a gluten challenge.
“We are delighted with the rapid recruitment of patients for this study and hope to report the results later this year,” reported Dr. Blake Paterson, Chief Executive at Alba. “Data from past clinical trials are promising and we expect the results of the current clinical evaluation to support what is planned for the Phase IIb trial.” The 86 patients enrolled in phase IIa were confirmed celiac by a positive biopsy and adhered to a gluten-free diet for at least six months before being recruited for the study. Patients were randomly separated into seven groups and received either the drug or a placebo and were challenged three times daily over a 14-day period.