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  • Scott Adams
    Scott Adams

    Alba Therapeutics Corporation Reports Preliminary Phase IIa Clinical Trial Results for AT-1001 for the Treatment of Celiac Disease

    Celiac.com 05/08/2007 - Announces Plans for Advancing AT-1001 into Later Stage Clinical Trials

    Alba Therapeutics Corporation today announced preliminary results from its Phase IIa clinical trial for AT-1001 in subjects with Celiac Disease (celiac disease), an autoimmune disease affecting over 3 million people in the United States. Albas study, the first Phase IIa trial in celiac disease and the first to assess dosing requirements for AT-1001 in celiac disease, was designed to evaluate the safety, tolerability and efficacy of multiple doses of AT-1001 in celiac disease subjects during a 2-week gluten challenge.

    The randomized, double-blind, placebo-controlled clinical trial enrolled 86 patients who were confirmed biopsy positive for celiac disease and in compliance with a gluten-free diet for at least six months prior to enrollment. Patients were randomized into seven drug-treated and placebo groups and challenged three times a day with gluten during a 14-day period. Four doses of the enteric coated oral formulation of AT-1001, all less than 10 mg, were given prior to each gluten challenge. Study endpoints included intestinal permeability (IP) -- a marker of disease state in celiac disease -- as well as patient symptoms and outcomes, measured by two validated tests of gastrointestinal disease outcome: the Gastrointestinal Symptoms Rating Scale (GSRS) and the Psychological General Well-Being Index (PGWBI).

    Preliminary analysis revealed the following:

    -- At day 14, IP, as measured by the change in urinary lactulose-to-
    mannitol (LA/MA) ratio, exhibited a dose dependent response. On day
    21, one week after the final drug dosing and gluten challenge, the dose
    dependent trend continued to statistically significant levels.

    -- The GSRS and PGWBI provided additional efficacy signals that further
    support the IP observations. Patients on the AT-1001 drug arms
    performed better than those on the gluten/placebo arm. Analyses
    demonstrated that several symptoms and outcomes improved at
    statistically significant levels.

    -- Safety and tolerability of multiple oral doses of AT-1001 in the
    patient population was demonstrated. There were no Severe Adverse
    Events and all Adverse Events were reported as mild or moderate.

    "We are very encouraged by the preliminary data and look forward to applying the extensive knowledge gained in this Phase IIa exploratory clinical trial to a larger, highly powered Phase IIb gluten challenge study later this year" said Blake Paterson, M.D., Chief Executive Officer of Alba Therapeutics. Using the highly complex and ambitious seven arm study design for the Phase IIa trial, we repeated the proof of concept from the Phase Ib study, showed a statistically significant effect across a variety of measures and are well prepared to move the celiac program forward."

    Based on these results, Alba will advance AT-1001 into a Phase IIb clinical study in celiac disease subjects during the third quarter of 2007. The Phase IIb study, to be performed in multiple centers in the United States and Canada, will assess the efficacy of AT-1001 utilizing multiple endpoints, including a composite index of disease activity. The first patient is expected to be enrolled into this study in the third quarter of 2007, and the study should conclude in early 2008.

    About Celiac Disease

    Celiac Disease 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 National Institutes of Health, celiac disease affects approximately 3 million Americans. The only current treatment for celiac disease is complete elimination of gluten from the diet, which results in remission for some patients.

    About Alba

    Alba Therapeutics Corporation is a privately held biopharmaceutical company based in Baltimore, Maryland dedicated to the development and commercialization of disease modifying therapeutics to treat autoimmune and inflammatory diseases based upon the regulation of tight junctions. Albas lead compound, AT-1001, is targeted towards the treatment of Celiac Disease, Inflammatory Bowel Disease and Type 1 Diabetes


    Contact: Stuart Sedlack, SVP, Corporate Development
    Phone: +1-410-319-0780



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  • About Me

    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 founded 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.

  • Related Articles

    Jefferson Adams
    Celiac.com 12/13/2011 - Alvine Pharmaceuticals, Inc. has announced that efficacy data from its Phase 2a clinical trial of ALV003 shows that oral ALV003, administered as part of a gluten free diet, reduced gluten-induced intestinal mucosal damage in people with well-controlled celiac disease.
    Alvine presented the study findings in a session of the 19th United European Gastroenterology Week (UEGW) in Stockholm.
    "These results are groundbreaking as they demonstrate for the first time, in a controlled clinical trial, that a drug has the potential to diminish gluten-induced injury in celiac disease patients," says Markku Maeki, M.D., chair and professor of pediatrics at the University of Tampere and Tampere University Hospital in Finland, and coordinating investigator of the ALV003 Phase 2a trial.
    Most people with celiac disease control their disease by following the gluten-free diet that is the only current treatment.
    Of those, many still suffer gluten-related discomfort and gut damage. In fact, Mr. Maeki adds, "up to 60 percent of adult celiac disease patients continue to experience symptoms and up to 80 percent continue to have persistent intestinal inflammation despite adhering to a strict gluten-free diet."
    Since gluten is so common in food processing, it's almost impossible to avoid ingesting tiny amounts of gluten, even for people with celiac disease.
    Gluten contamination commonly occurs via cross-contamination in the processing of food products, incorrect or inaccurate labeling, lack of dietary education and awareness, and even due to willful back-sliding on the part of otherwise faithful gluten-free dieters.
    According to Dr. Maeki, non-dietary treatment options that either eliminate, or significantly reduce gluten ingestion by those attempting a gluten-free diet are needed, "ecause it is all but impossible to avoid gluten, even while adhering to a gluten-free diet, celiac patients are at continued risk for gastrointestinal symptoms and potentially serious long-term medical consequences."
    The study is constructed as a double-blind, placebo-controlled Phase 2a clinical trial on 41 adults with well-documented celiac disease, who had followed on a gluten-free diet for one or more years. Study participants were randomly given ALV003 or a placebo each day for six weeks. At the same time, they were given 2g of gluten in the form of bread crumbs.
    Each member of the study received small bowel biopsy at the beginning of the trial, and then again after six weeks of daily gluten challenge.
    The study's primary endpoint was intestinal mucosal morphometry (villus height:Crypt depth)(or vh:celiac disease) measured at baseline and at six weeks.
    Secondary endpoints included intraepithelial lymphocyte (IEL) density (cells/mm), gastrointestinal symptoms as measured by Gastrointestinal Symptom Rating Scale (GSRS) scores, celiac serologies, safety and tolerability.
    The study was statistically powered for the primary endpoint of change in Vh:celiac disease with six weeks of gluten exposure. Results from 34 celiac disease patients eligible for analysis showed that after six weeks:
    --  Biopsy data demonstrated significantly less small intestinal mucosal injury as measured by Vh:celiac disease in patients treated with ALV003 than in placebo-treated patients (p=0.0133).
    --  IELs, including CD3+ and CD3+ alpha/beta and gamma/delta subsets, which measure inflammatory response, were essentially unchanged in the ALV003-treated patients but significantly increased in the placebo-treated patients.
        ------------------------------------------------------------------------
                                        Change from Week 0                     p value
                                             to Week 6
        ------------------------------------------------------------------------
                               ALV003 (n=16)      Placebo (n=18)
        ------------------------------------------------------------------------
         Vh:celiac disease                                -0.2                -0.8         0.0133
        ------------------------------------------------------------------------
          CD3+ IELs                      +2.4               +30.8        0.0152
        ------------------------------------------------------------------------
        CD3 alpha/beta IELs         -1.8               +24.2         0.003
        ------------------------------------------------------------------------
        CD3 gamma/delta IELs    +0.5               +10.9         0.003
        ------------------------------------------------------------------------
                
    --  Overall GSRS scores and scores for indigestion and abdominal pain symptoms were lower in ALV003-treated patients than in placebo-treated patients, although the results were not statistically significant.
    --  No statistically significant changes were observed in celiac disease serology tests between the ALV003 and placebo-treated patients, although positive trends were observed for tissue transglutaminase (tTG) and deamidated gliadin peptide (DGP) antibodies in the ALV003-treated group, a measure of immune responsiveness.
    --  No serious adverse events were reported. Non-serious adverse events consistently occurred more frequently in the placebo-treated patients. Adverse events that occurred in 10 percent or more patients included abdominal distention, flatulence, eructation, abdominal pain and diarrhea.

    Source:

    http://www.marketwatch.com/story/alvine-pharmaceuticals-presents-additional-efficacy-data-from-phase-2a-trial-of-alv003-in-celiac-disease-patients-2011-10-24

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