Alba Therapeutics Corp. today announced that it had dosed its first patient in a Phase II trial for the treatment of Celiac Disease (CD). In October of last year, the FDA granted
"Fast Track" designation to AT-1001, an orally administered zonulin
receptor antagonist for treatment of Celiac Disease.
The multi-center, double blind, placebo controlled dose ranging study
will evaluate the safety, tolerability and efficacy of AT-1001 in 79 Celiac
Disease subjects during gluten challenge. "The initiation of the Phase II
CD study is an important milestone for Alba Therapeutics as we continue to
build our clinical experience with this disease and advance our program
towards additional therapeutic applications for our zonulin antagonists,"
stated Dr. Blake Paterson, CEO of Alba. "Our understanding of the zonulin
pathway coupled with AT-1001's excellent safety profile and the positive
Phase Ib proof of concept data lead us to believe that the Phase II study
will yield high quality results. Moreover, because there is no effective
treatment for CD, entry into Phase II studies is a tremendous step forward
for those patients suffering from this disease and other autoimmune
diseases.
About Celiac Disease
Celiac disease ("CD") 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 Zonulin
Zonulin is an endogenous signaling protein that transiently and
reversibly opens the tight junctions ("tj") between the cells of epithelial
and endothelial tissues such as the intestinal mucosa, blood brain barrier
and pulmonary epithelia. Discovered by Alba's co-founder, Dr. Alessio
Fasano, zonulin appears to be involved in many disease states in which
leakage occurs via paracellular transport across epithelial and endothelial
tight junctions (tj), and thus may play an important potential role in the
treatment of autoimmune and inflammatory diseases.
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 molecule, AT-1001, is targeted
towards the treatment of Celiac Disease and Type 1 Diabetes.
Alba Therapeutics Corp.
albatherapeutics