Upcoming Webinars Archived Webinars Training Vitals Host A Webinar About Get Updates Contact

ImmusanT Releases Phase I Clinical Trial Results for Celiac Therapeutic

XTALKS VITALS NEWS

Wheat

Celiac disease is a chronic immune-modulated disease in which exposure to dietary gluten causes damage to the gastrointestinal lining.

Share this!

February 24, 2017 | by Sarah Hand, M.Sc.

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.


Keywords: Clinical Trial, Immunotherapy, Celiac Disease


| NEXT ARTICLE | MORE NEWS | BLOGS | VIDEOS | POLLS & QUIZZES | WEBINARS |

Share this with your colleagues!

MORE NEWS
Gilead’s Newest Hepatitis C Drug Gets FDA Approval

July 21, 2017 - Dominant player in the chronic hepatitis C virus (HCV) market Gilead has received US Food and Drug Administration (FDA) approval for its newest treatment, Vosevi.

Featured In: Pharmaceutical News


Detecting Alzheimer’s Biomarkers in the Blood Could Improve Early Diagnosis

July 20, 2017 - In an effort to improve rates of early diagnosis and intervention, researchers at Washington University in St. Louis have developed a blood test that can detect some of the hallmarks of Alzheimer’s disease.

Featured In: Biotech News


Insurance Coverage Under the Affordable Care Act Supports Clinical Trial Enrollment, Says Study

July 20, 2017 - Since the Patient Protection and Affordable Care Act (ACA) was passed in 2010, insurance approval for patients wishing to participate in oncology clinical trials has increased, according to a recent study published in the journal, Clinical Cancer Research.

Featured In: Clinical Trial News


LEAVE A COMMENT
 
  
THE XTALKS VITALS INDUSTRY BLOG

Manufacturing Control Strategies: What Pharmaceutical and Biotech Companies Need to Know

REGISTER FOR THESE WEBINARS

Outsourcing Pharmacovigilance: Pros and Cons and Lessons Learned


EDC and eSource: Combined for Better Data and Faster Insights


Using Model Reduction to Bridge the Quality Systems Pharmacology-Pharmacometrics Divide


How to Maximize Your Non-GLP Toxicology Studies: A Guide for Optimal Design and Methodology


Copyright © 2016-2017 Honeycomb Worldwide Inc.