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Small Drug Firm Announces Completion of First Human Trial for AT-1001 and FDA 'Fast Track' Designation for Possible Future Celiac Disease Treatment
Fast track process is designed to facilitate development and expedite the review of new drugs with the potential to address significant unmet medical needs for the treatment of serious or life-threatening conditions. Potential fast track benefits include FDA input into development, submitting new drug applications in sections rather than all at once and the option of requesting Accelerated Approval.
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. Gluten is a mixture of proteins found in common food grains such as wheat, rye and barley. According to the NIH, celiac disease affects approximately 3 million Americans, although the diagnosis is rarely made. The only treatment for celiac disease is complete elimination of gluten from the diet, which results in remission for some patients.
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 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 auto-immune diseases.
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. Albas lead molecule, AT-1001, is targeted towards the treatment of Celiac Disease and Type 1 Diabetes.
Contact: Dr. Blake Paterson
Alba Therapeutics Corporation
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AT-1001 May Be Effective Treatment for Celiac Disease
A study published recently
in the journal of Alimentary Pharmacology and Therapeutics shows that
the paracellular permeability inhibitor AT-1001 effectively reduces intestinal
barrier dysfunction, proinflammatory cytokine production, and gastrointestinal
symptoms in people who have celiac disease.... [READ MORE]
Alba Therapeutics Announces Positive Celiac Disease Trial Results
Alba Therapeutics Corporation
announced today successful completion of Phase Ib proof-of-concept studies
for its lead compound, AT1001.... [READ MORE]
FDA Approves Clinical Trial of BioBalance Corporation's Probactrix for Possible Celiac Disease Treatment
The BioBalance Corp.... [READ MORE]
Future Enzyme Treatment Possible for People with Celiac Disease
J Pharmacol Exp Ther.... [READ MORE]
In 1994 I was diagnosed with celiac disease, which led me to create Celiac.com in 1995. I created this site for a single purpose: To help as many people as possible with celiac disease get diagnosed so they can begin to live happy, healthy gluten-free lives. Celiac.com was the first site on the Internet dedicated solely to celiac disease. In 1998 I foundedÂ The Gluten-Free Mall, Your Special Diet Superstore!, and I am the co-author of the book Cereal Killers, and founder and publisher of Journal of Gluten Sensitivity.View all articles by Scott Adams
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