The below content is from a press release from Alvine Pharmaceuticals. According to Daniel Adelman, MD, Alvine Chief Medical Officer, "Alvine is expecting to start a phase 2b study at several clinical centers in the United States and Canada in the Spring of 2013. The study will enroll celiac disease patients who are experiencing symptoms despite attempting to adhere to a gluten-free diet. More information of the clinical trial and participating study centers will be made available closer to the study start-up."
SAN CARLOS, Calif.--(BUSINESS WIRE)--Alvine Pharmaceuticals, Inc., a leader in celiac disease therapeutics development, today announced the presentation of patient-reported outcomes data at the 2012 American College of Gastroenterology meeting in Las Vegas, NV. The poster presentation included data on the frequency and severity of symptoms experienced by celiac disease patients attempting to adhere to a gluten-free diet. In the study, a disease-specific patient-reported outcome diary was used to collect daily symptom data from celiac disease patients.
“Evaluation of Patient Reported Outcome Instruments in Celiac Disease Patients”
The study enrolled 202 patients with biopsy-documented celiac disease who had experienced gastrointestinal or non-gastrointestinal celiac disease-related symptoms during the previous 3 months despite being on a gluten-free diet. Patients were required to complete a daily symptom diary, called the Celiac Disease Symptom Diary (“CDSD©”) over a seven day period using a telephonic interactive voice response system; this study was conducted without any therapeutic intervention. The CDSD© is a disease specific patient reported outcome (“PRO”) diary, developed in line with the US Food and Drug Administration PRO Guidance. The diary collects information on symptoms common to celiac disease patients: abdominal pain, bloating, constipation, diarrhea, fatigue, flatulence, headache, nausea, skin rash and problems thinking clearly. For any symptoms a patient experienced over each 24 hour period, a series of questions were asked that established the severity and impact on daily functioning related to that symptom.
Over 90% of the patients reported at least 1 day of symptoms, and 44% reported 5-10 symptoms during the 7 day period. For each symptom, the percent of patients reporting that symptom at least once during the reporting period was: flatulence 63%, abdominal pain 62%, fatigue 56%, bloating 54%, diarrhea 46%, constipation 42%, nausea 35%, difficulty thinking 35%, headache 31% and skin rash 17%. Seventy-six percent of patients reported their symptoms were at least moderate to very severe in intensity and that those symptoms affected their perceived quality of life.
“The results of this study show that the majority of patients with celiac disease continue to experience disease-related symptoms ranging from mild to severe even while attempting to adhere to a gluten-free diet,” said Daniel Adelman, M.D., Alvine’s Senior Vice President and Chief Medical Officer. “The development of a sensitive celiac disease specific patient-reported outcome instrument, the CDSD© allows for an accurate assessment and characterization of the frequency and severity of symptoms experienced by patients with celiac disease. The CDSD© will be an important tool for use in future clinical studies of our investigational product, ALV003 in an upcoming phase 2b study.”
The abstract of the poster presentation can be accessed on the ACG website: http://www.eventscribe.com/2012/acg/SearchPostersByKeyword.asp and inserting poster number P373 at the prompt.
Information on Alvine’s current clinical trial titled “Evaluation of Patient Reported Outcome Instruments in Celiac Disease Patients” can be found at the NIH website: http://clinicaltrials.gov/ct2/show/NCT01560169.
ALV003 is an orally administered mixture of two recombinant gluten-specific proteases, a cysteine protease (EP-B2) and a prolyl endopeptidase (PEP). ALV003 targets gluten and degrades it into small fragments, which, in vitro, diminishes its immunogenicity. ALV003 is being developed as a potential treatment for celiac disease patients in conjunction with a gluten-free diet and is currently in phase 2 clinical development.
Alvine Pharmaceuticals, Inc. is a private, clinical-stage, specialty biopharmaceutical company located in San Carlos, Calif., focused on the development of biologics targeting autoimmune and inflammatory diseases, including celiac disease. Alvine is focusing clinical development efforts on ALV003, an investigational drug in phase 2 trials that could potentially be the first approved therapeutic treatment for patients with celiac disease. For additional information about the company, please visit http://www.alvinepharma.com.