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Alba Announces Completion Of Enrollment And Dosing Of Patients In Phase II Clinical Trial Of AT-1001 For The Treatment Of Celiac Disease
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.
About AT-1001
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.
About Alba
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.
Alba Therapeutics Corporation
http://www.albatherapeutics.com
Alba anunta finalizarea de înscriere ºi de dozare de pacienþi din studiul clinic de fazã II-a, la 1001, pentru tratamentul bolii de Celiac - Alba Announces Completion Of Enrollment And Dosing Of Patients In Phase II Clinical Trial Of AT-1001 For The Treatment Of Celiac Disease - articole medicale engleza - startsanatate