Alba Announces Completion of Enrollment and Dosing of Patients in Phase II Clinical Trial of AT-1001 for the Treatment of Celiac Disease
BALTIMORE, Md. March 8, 2007 /PRNewswire/ -- Alba Therapeutics Corporation today announced it has completed enrollment and dosing of patients in its Phase IIa dose ranging clinical trial of AT-1001, the Company's lead orally administered zonulin receptor antagonist drug candidate for the treatment of Celiac Disease (“CD”). The randomized, double-blind, placebo-controlled clinical trial is designed to evaluate the safety, tolerability and efficacy of AT-1001 in 86 CD subjects during gluten challenge.
"We are pleased with the rapid enrollment of this study and look forward to reporting its results later this year," said Dr. Blake Paterson, CEO of Alba. "Previously reported AT-1001 clinical trial data has been promising and we expect that the results of our ongoing clinical evaluation will support our Phase IIb trial design." The 86 patients enrolled in the Phase IIa study were confirmed biopsy positive for CD and in compliance with a gluten-free diet for at least six months prior to enrollment. Patients were randomized into seven drug-treated and placebo groups and challenged three times a day with gluten for a 14 day period.
About Celiac Disease
Celiac Disease is a T-cell mediated auto-immune disease that occurs in genetically susceptible individuals and is characterized by small intestinal inflammation, injury and intolerance to gluten. According to the National Institutes of Health, CD affects approximately 3 million Americans. The only current treatment for CD is complete elimination of gluten from the diet, which results in remission for some patients.
AT-1001 is an orally administered octapeptide zonulin receptor antagonist that appears to exert its inhibitory effect on gliadin-induced tight junction disassembly by blocking putative zonulin receptors on the luminal surface of the small intestine. Pretreatment with the peptide fails to inhibit gliadin induced zonulin release, while administration of zonulin analogues or gliadin in the presence of AT-1001 fail to significantly affect intestinal permeability, confirming the effect of the molecule is specific to the zonulin receptor. AT-1001 is currently under investigation in a multicenter, double blind, placebo controlled Phase II dose ranging study to evaluate the safety, tolerability and efficacy of AT-1001 in 86 CD subjects during gluten challenge.
Alba Therapeutics Corporation is a privately held biopharmaceutical company based in Baltimore, Maryland . Alba is dedicated to commercializing disease-modifying therapeutics and vaccine and drug delivery adjuvants based on the zonulin pathway. Alba’s lead compound, AT-1001, is targeted towards the treatment of Celiac Disease, Inflammatory Bowel Disease and Type 1 Diabetes.