ImmusanT, a privately-held biotechnology company focused on restoring tolerance to gluten in celiac disease, has initiated clinical trials in New Zealand, Australia and the US to evaluate Nexvax2, the first therapeutic vaccine for patients with celiac disease.
Nexvax2 is designed to re-establish patients’ tolerance to the toxic effects of gluten, a protein in wheat, barley and rye, and allow them to return to a normal diet.
There are currently no approved medicines available for people with celiac disease, who must manage their condition by eliminating gluten-containing foods from their diet.
Advancing the earlier Nexvax2 clinical trial, the new program underway in Australia and New Zealand is a randomized, double-blind, placebo-controlled phase I b study evaluating multiple ascending doses of Nexvax2 for the induction of gluten tolerance in patients on a gluten-free diet. ImmusanT expects to enroll 84 subjects at approximately four study sites in the two countries in order to evaluate safety, tolerability and pharmacokinetics, and to select doses for investigation in subsequent studies.
The second study, a randomized, double-blind, placebo-controlled phase I trial being conducted in the US is to determine the safety, tolerability and pharmacokinetic profile of Nexvax2 in patients with celiac disease well controlled by a gluten-free diet. ImmusanT plans to enroll 30 adult subjects at approximately four trial sites.
“We are kicking-off a robust clinical program that we hope demonstrates Nexvax2 dramatically reduces the body’s immune response to dietary gluten so patients can resume a normal diet and return to good health,” said Patrick H Griffin, MD, chief medical officer of ImmusanT. Griffin added, “Our clinical development programme will allow us to further examine the role of antigen-specific T cells in celiac disease activation and in the re-establishment of tolerance to gluten.”
“There has been tremendous enthusiasm about Nexvax2 from patients and the medical community and this will provide terrific momentum for advancing our clinical programme,” said Leslie J Williams, president and CEO of ImmusanT.
BD (Becton, Dickinson and Company) is supplying novel intradermal injection solutions to ImmusanT to administer Nexvax2 in its clinical programme. These solutions are based on BD’s commercialized intradermal injection technology, BD Soluvia Microinjection System. BD has a longstanding history of developing and commercializing novel prefillable vaccine delivery systems. As compared with the traditional intradermal injection method, BD’s intradermal injection technologies allow for a clinician to use an injection technique that is perpendicular to the skin. This helps simplify the administration process while improving the success of intradermal injections.
In ImmusanT’s international trials, patients will have a confirmed diagnosis of celiac disease and carry the immune recognition gene HLA-DQ2. Up to 90 per cent of individuals with celiac disease have this gene. Furthermore, prospective patients will be screened using the company’s companion diagnostic technology to identify suitable candidates for the therapeutic vaccine. ImmusanT will use this novel blood test to measure gluten-reactive T cells in celiac disease as a potential marker for immune modulation with Nexvax2.
Nexvax2 is a therapeutic vaccine that combines three proprietary peptides that elicit an immune response in patients with celiac disease who carry the immune recognition gene HLA-DQ2. In an approach similar to treatments for allergies to cats and dust mites, Nexvax2 is designed to reprogramme gluten-specific T cells triggered by the patient’s immune response to the protein. The goal is for Nexvax2 to restore celiac patients’ immune tolerance to gluten, reduce inflammation in the nutrient-absorbing villi that line the small intestine, return the intestine to a healthy state, and allow patients to eat a normal diet.
Celiac disease is an inherited autoimmune disorder that affects the digestive process of the small intestine. When a person with celiac disease consumes gluten, a protein found in wheat, rye and barley, the individual’s immune system responds by triggering T cells to fight the offending proteins, damaging the small intestine and inhibiting the absorption of important nutrients into the body. With no available drug therapy, the only option for the approximately 1 per cent of the global population that has celiac disease is to eliminate gluten from the diet.