Zonulin Antagonist AT-1001
September 27, 2005
BALTIMORE--(BUSINESS WIRE)--Sept. 27, 2005--Alba Therapeutics Corp. today announced that it has
begun first human dosing of AT-1001, an orally administered zonulin receptor antagonist that is being
developed for the treatment of Celiac Disease (CD). The double blind, placebo controlled dose escalation
study will evaluate the safety, tolerability and pharmacokinetics of AT-1001 and is being conducted in
twenty-four normal volunteers. "The data we plan to generate from this and subsequent Phase 1 studies
will educate us on the safety and tolerability of AT-1001, in addition to quantifying the impact of this novel
compound on intestinal permeability," stated Dr. Blake Paterson, CEO of Alba. "Advancing AT-1001 into
clinical trials represents a significant milestone both in our Company's history and in the establishment of
our clinical pipeline," said Dr. Paterson. "It is a great day for celiac patients and we look forward to rapidly
generating the clinical data necessary for the continued development of AT-1001 as a potential therapy for
CD and other autoimmune diseases."
About Celiac Disease
CD is an auto-immune disease that occurs in genetically susceptible individuals and is characterized by
small intestinal inflammation, injury and intolerance to gluten. Gluten is a mixture of proteins found in
common food grains such as wheat, rye and barley that triggers T-cell mediated autoimmunity in CD
patients. According to the NIH, Celiac Disease affects approximately 3 million Americans, although the
diagnosis is rarely made. The only 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
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 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.
Contacts
Contacts:
Alba Therapeutics Corporation, Baltimore
Dr. Blake Paterson
410-522-8708
bpaterson@albatherapeutics.com
September 27, 2005
BALTIMORE--(BUSINESS WIRE)--Sept. 27, 2005--Alba Therapeutics Corp. today announced that it has
begun first human dosing of AT-1001, an orally administered zonulin receptor antagonist that is being
developed for the treatment of Celiac Disease (CD). The double blind, placebo controlled dose escalation
study will evaluate the safety, tolerability and pharmacokinetics of AT-1001 and is being conducted in
twenty-four normal volunteers. "The data we plan to generate from this and subsequent Phase 1 studies
will educate us on the safety and tolerability of AT-1001, in addition to quantifying the impact of this novel
compound on intestinal permeability," stated Dr. Blake Paterson, CEO of Alba. "Advancing AT-1001 into
clinical trials represents a significant milestone both in our Company's history and in the establishment of
our clinical pipeline," said Dr. Paterson. "It is a great day for celiac patients and we look forward to rapidly
generating the clinical data necessary for the continued development of AT-1001 as a potential therapy for
CD and other autoimmune diseases."
About Celiac Disease
CD is an auto-immune disease that occurs in genetically susceptible individuals and is characterized by
small intestinal inflammation, injury and intolerance to gluten. Gluten is a mixture of proteins found in
common food grains such as wheat, rye and barley that triggers T-cell mediated autoimmunity in CD
patients. According to the NIH, Celiac Disease affects approximately 3 million Americans, although the
diagnosis is rarely made. The only 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
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 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.
Contacts
Contacts:
Alba Therapeutics Corporation, Baltimore
Dr. Blake Paterson
410-522-8708
bpaterson@albatherapeutics.com
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