Alba Therapeutics Announces Phase I Trial for Zonulin Antagonist AT-1001
Posted on: Tuesday, 27 September 2005, 09:00 CDT
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.
Source: Business Wire
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