Results of a Drug Trial Conducted in Finland in Celiac Disease Patients Presented at the United European Gastroenterology Week Meeting in Stockholm
Alvine Pharmaceuticals, Inc. California, USA, announced positive results from its phase 2a celiac disease trial with ALV003 at the United European Gastroenterolgy Week (UEGW) scientific meeting in Stockholm. In this clinical trial it was shown that ALV003 diminished gluten-induced intestinal mucosal injury in celiac disease. The study was conducted as a multicenter trial in Finland, coordinated by FinnMedi Oy. Based on the positive phase 2a results, a phase 2b clinical trial is targeted to start in 2012.
The clinical trial was conducted in Finland (Tampere, Kuopio, Oulu). Six doctors and five study nurses worked in the study centers. Trial operative functions were led by Tiina Kärjä-Lahdensuu FinnMedi Oy (operative functions and regulatory), and researchers in Tampere University Celiac Disease Research Group: Marja-Leena Lähdeaho, MD (Principal Investigator) and Professor Markku Mäki (celiac disease scientific research, Coordinating Responsible investigator in charge of patient safety in Finland).
“Clinical research makes it possible for new treatments to be available in the future,” said Tiina Kärjä-Lahdensuu. “This clinical trial was the fourth trial in celiac disease completed in collaboration with FinnMedi Oy, University of Tampere and Tampere University Hospital in Finland. These preliminary positive results encourage us to continue collaborating with the Biopharmaceutical Industry at an international level.”
“I’d like to express my gratitude to the Celiac Disease Patient Association in Finland and its member associations, who have improved the lives of celiacs with their long term work and increased awareness of celiac disease in Finland. A special thanks to all celiac patients who volunteered to participate in clinical trials of novel compounds targeting celiac disease; without them this trial could not have been completed,” added Kärjä-Lahdensuu.
“There are currently no approved therapies for celiac disease. Strict, life-long adherence to a gluten-free diet is the current standard of care and the only treatment option for these patients, but this does not offer a comprehensive solution,” says Marja-Leena Lähdeaho, Principal Investigator. “A gluten-free diet does not completely prevent exposure to gluten and does not affect the underlying cause of disease, potentially leaving patients vulnerable to the effects of gluten on gastrointestinal symptoms and the potential for serious long-term medical consequences.”
Clinical Trial Design and Results
Forty-one well-controlled celiac disease patients who were maintained on a GFD for one or more years participated in the trial. Half of study patients received ALV003 as study drug and the other half received placebo for six weeks at the time of ingestion of 2g of daily gluten (equivalent to approximately one-half of a slice of bread). Study participants underwent small bowel biopsy at the beginning of the trial and at the end of the trial. The primary endpoint was intestinal mucosal changes caused by gluten, which were evaluated from the biopsy samples taken.
Additionally mucosal intraepithelial lymphocyte (IEL) density was evaluated at the beginning and end of the trial. Blood samples were taken for antibody evaluation common in celiac disease and also to ensure study drug safety. Gastrointestinal symptoms were measured with a symptom questionnaire. Also study drug safety and tolerability was evaluated.
“Based on the results of this rigorously conducted and controlled clinical trial, we believe that clinical proof-of-principle has been achieved. We are currently preparing for a Phase 2b trial of ALV003 in celiac disease patients targeted to begin in 2012,” tells Daniel Adelman, chief medical officer at Alvine Pharmaceuticals.
“These results are important 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” said Markku Mäki, Director of Celiac Disease Research Group, Professor at the University of Tampere.
Conducting the clinical trial:
Celiac Disease Research and Celiac Disease:
Markku Mäki, Professor, Director of the Celiac Disease Research Group, University of Tampere, tel. +358 50 365 6668, markku.maki(at)uta.fi
UEGW Data Presentation and Conference Call
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