NEWPORT BEACH, Calif.--(BUSINESS WIRE)--ImmunogenX is pleased to announce the publication of the manuscript “Latiglutenase Improves Symptoms in Seropositive Celiac Disease Patients while on a Gluten-Free Diet” in Digestive Diseases & Sciences (Full reference: Syage JA, Murray JA, Green PHR, Khosla C. Dig Dis Sci (2017) 62:2428-2432; DOI 10.1007/s10620-017-4687-7).
These results are based on the recent ALV003-1221 trial for latiglutenase (CeliAction® Study), which reported, as a secondary endpoint, statistically significant improvement in certain symptoms for celiac disease (CD) patients on latiglutenase. Post hoc analysis affirmed a linear dose dependence for abdominal pain, bloating, tiredness, and constipation for patients who entered the trial seropositive for antibody markers of CD despite being on a gluten-free diet. This analysis also showed reduction in symptoms relative to placebo for the higher doses ranging from 32% to 54%.
The evident benefit of latiglutenase has recently received significant recognition by being selected as a lecture presentation (top 5% of contributions) at Digestive Disease Week (DDW) in May 2017, the largest gastroenterology meeting in the world. These results will also be presented at the International Celiac Disease Symposium in India in September 2017.
Dr. Jennifer Sealey-Voyksner, CSO, commented: “The CeliAction trial is the largest therapeutic trial conducted for celiac disease to date and showed that latiglutenase can attenuate symptoms of celiac disease in patients who remain seropositive. This subclass of patients represents the 10-20% of patients who are most burdened by the disease. As a diagnosed celiac patient myself, it is very gratifying to be able to offer a new therapeutic option pending successful completion of the clinical development program and FDA approval.”
Dr. Joseph Murray, a co-author of the publication, remarked: “Though the ALV003-1221 trial was inconclusive regarding histologic improvement from latiglutenase, the evidence for symptom benefit, which is more quickly achieved, is quite convincing and clinically relevant. This subanalysis demonstrates that a therapy to help patients struggling with symptoms due to celiac disease is now within reach.”
ImmunogenX (a subsidiary of Immunogenics LLC) is a clinical-stage biotherapeutics company founded in 2013 and is supported by a team of world-renowned clinicians, scientists, and advisors in celiac disease research. The company is developing latiglutenase (formerly ALV003) for celiac disease therapy. ImmunogenX is also developing a minimally invasive diagnostic tool for celiac disease management (CypCel™) based on a clinically relevant metabolic marker compound that can assess the state of recovery of a celiac patient adhering to a gluten-free diet or other treatment. For food safety, ImmunogenX is pioneering advanced mass spectrometry methods to identify and measure physiologically relevant gluten peptide sequences found in wheat, barley, and rye.