Massachusetts-based biotech company ImmusanT, has completed a Phase Ib clinical trial for its celiac disease vaccine, Nexvax2. The therapeutic – which is designed to protect against the effects of gluten exposure – met its objectives in terms of safety and efficacy.
Celiac disease is a chronic immune-modulated disease in which exposure to dietary gluten causes damage to the gastrointestinal lining. Aside from dietary restriction, there is no pharmacological treatment for this disease which effects an estimated one percent of the population in the US.
Approximately 90 percent of patients carry the human leukocyte antigen-DQ2.5 (HLA-DQ2.5) immune recognition gene, which has been implicated in the genetic basis of the condition. ImmusanT’s Nexvax2 is an immunotherapy consisting of three peptides designed to promote gluten tolerance in the intestine.
The Phase Ib dose titration clinical trial involved 38 patients with celiac disease who were randomly assigned to one of three cohorts based upon HLA-DQ2.5 genotype. Patients received either escalating doses of Nexvax2, or a placebo, and study results will help inform a dosing regimen for a further Phase II trial.
Previous study results found that while patients given a fixed dose of Nexvax2 initially experienced transient immune activation and symptoms associated with gluten consumption, future doses did not trigger an immune response. No safety concerns were identified during the current clinical trial.
“We are very pleased with the completion of our Phase 1b clinical trial testing Nexvax2 in patients with HLA-DQ2.5+ celiac disease,” said Leslie Williams, President and Chief Executive Officer of ImmusanT. “This study has informed the design of our planned Phase 2 clinical trial for Nexvax2 in patients with celiac disease. Nexvax2 has the potential to protect against the effects of gluten exposure in patients with celiac disease and improve their quality of life.”
Should future trials show similarly promising results, ImmusanT will likely seek US Food and Drug Administration (FDA) approval for Nexvax2 as a therapeutic to protect celiac patients who are accidently exposed to gluten. The company is also developing a companion diagnostic and monitoring tool to help identify those who may benefit from ImmusanT.
It’s estimated that over 80 percent of cases of celiac disease are undiagnosed in the US. While a gluten-free diet is imperative for disease management, adherence can be difficult leaving patients open to further intestinal damage flowing exposure to gluten.