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

Announces Plans for Advancing AT-1001 into Later Stage Clinical Trials

    BALTIMORE, May 7 /PRNewswire/ -- Alba Therapeutics Corporation today
 announced preliminary results from its Phase IIa clinical trial for AT-1001
 in subjects with Celiac Disease (CD), an autoimmune disease affecting over
 3 million people in the United States. Alba's study, the first Phase IIa
 trial in CD and the first to assess dosing requirements for AT-1001 in CD,
 was designed to evaluate the safety, tolerability and efficacy of multiple
 doses of AT-1001 in CD subjects during a 2-week gluten challenge.
     The randomized, double-blind, placebo-controlled clinical trial
 enrolled 86 patients who were confirmed biopsy positive for CD 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 CD -- 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 CD 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, 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.
     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. Alba's
 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
     E-mail:   info@albatherapeutics.com
     Web site: http://www.albatherapeutics.com
 
 

SOURCE Alba Therapeutics Corporation