Alba Therapeutics has announced the successful completion of multidose safety studies in normal volunteers, concluding Phase I trials for its lead compound, oral AT-1001. Combined with Alba's previous single-dose study and Phase Ib demonstration of intestinal permeability decrease in gluten-challenged celiac disease (CD) patients, this safety data brings the company closer to its goal of delivering an autoimmune treatment based upon modulation of mucosal barrier function.
CD is a T-cell mediated autoimmune disease that occurs in genetically susceptible individuals and is characterized by small intestinal inflammation, injury and intolerance to gluten. According to the NIH, 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.