The FDA’s Fast Track is a process which speeds the review of drugs—a lengthy, multiyear process—to fill an unmet medical need and get important medications to patients sooner.
Currently, there is no FDA-approved drug for the treatment of celiac disease. The only course of action available to celiac patients is to adhere to a strict, gluten-free diet, despite mounting evidence the diet alone is not enough for many of those suffering from ongoing symptoms and intestinal damage.
ImmusanT hopes Nexvax2 will change that reality by bringing their revolutionary therapeutic vaccine to the market sooner. Nexvax2 works by leveraging the body’s own immune system to treat celiac disease in patients with the HLA DQ2.5 gene (approximately 90% of celiac patients). The concept is that patients would start with a small dose of the vaccine and gradually increase the dose, allowing the body to build up resistence to the problematic protein in gluten, without the associated negative effects of consuming gluten.
Nexvax2 aims to protect celiac patients from accidental exposure to gluten, however, ImmusanT’s Chief Scientific Officer, Dr. Robert Anderson, believes this type of treatment could potentially allow patients to safely resume a gluten-containing diet one day.
“Nexvax2 has been designed to re-educate the body’s immune system to help protect celiac disease patients from the side effects associated with inadvertent exposure to gluten,” said Dr. Anderson. “Today, the only solution for patients with celiac disease is adherence to a strict, lifelong gluten-free diet. It is our hope that if approved, Nexvax2 will become the standard-of-care for patients with this condition.”
The biggest obstacle in getting a celiac drug to market is recruiting enough patients to participate in clinical trials. The Celiac Disease Foundation has been working with ImmusanT to fast-track patient recruitment for the Nexvax2 phase 2 clinical trial, the ReseT CeD Study. Through the Foundation’s iQualifyCeliac clinical trial screening tool, hundreds of patients have been able to find out within minutes whether they may qualify for this game-changing clinical trial, in addition to other studies currently enrolling patients.
Leslie Williams, Chief Executive Officer for ImmusanT, stated, “We are committed to bringing life-changing solutions to patients with a variety of autoimmune disorders, including celiac disease. Organizations such as the Celiac Disease Foundation and its iCureCeliac® patient registry have been integral in this process, as they have helped significantly expedite our recruitment efforts for Nexvax2. The more quickly we can recruit patients, the more quickly we can develop what we hope to be the world’s first disease-modifying therapeutic for celiac disease.”
Nexvax2 Therapeutic Vaccine Fast-Tracked by FDA