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The Dermatitis Herpetiformis Online Community Blog
This weblog (blog) is a place for me to post articles of interest for people with DH and coeliac disease and enables me to communicate notices to site visitors. If you'd like to be advised when new posts are added, please either subscribe to the web feed or sign up for email notifications.
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 multicenter, 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 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.
Patients with celiac disease have to carefully monitor their diet to avoid consuming gluten, a ubiquitous protein found in whole grains.
Now, researchers say a newly discovered enzyme may prevent an allergic reaction in celiac patients who have accidentally consumed gluten.
Gluten causes an inflammatory reaction that can lead to significant intestinal damage in people suffering from celiac disease. The damage prevents the intestine from properly absorbing nutrients from food. Avoiding gluten in the diet prevents this damage, but the risk of accidentally ingesting gluten remains high.
However, researchers at Stanford University say they've identified an enzyme called EP-B2 that successfully digested gluten in an acidic environment similar to that of a human stomach. The enzyme even broke down the elements of the protein associated with causing the inflammatory reactions in celiac patients.
"Non-dietary therapies that allow celiac patients to safely incorporate low-to-moderate levels of gluten into their daily diet would be of considerable benefit," study author Dr. Chaitan Khosla, of Stanford University and the Celiac Sprue Research Foundation, said in a prepared statement. "Having demonstrated earlier that certain types of enzymes can detoxify gluten, our laboratory set out to devise an optimal oral enzyme therapy for celiac sprue by borrowing from nature," Khosla said.
"In germinating barley seed, gluten serves as a nutritious storage protein that is efficiently digested by enzymes. One enzyme, EP-B2, plays a crucial role in this process by breaking gluten proteins after glutamine residues, which comprise one-third of all amino acid residues in gluten," Khosla added.
Khosla's team used a combination of EP-B2 and PEP, another enzyme known to digest gluten. The two enzymes together broke down and detoxified gluten within 10 minutes. Neither was effective when used alone.
"Our results suggest that recombinant EP-B2 should be effective as supportive therapy to help celiacs cope with the 'hidden' gluten in everyday life, and that a two-enzyme cocktail containing PEP and EP-B2 may even allow celiacs to resume a more normal diet in the future," concluded Khosla.