A vaccine for coeliac disease could soon be made available with the Australian-developed immunisation gaining fast-track designation from America’s Food and Drug Administration.
ImmusanT’s Nexvax2, developed at the Walter and Eliza Hall Institute (WEHI) in Victoria, is set for a prompt review at the completion of its trial phases.
Currently phase two, involving 150 patients across Australia, the US and New Zealand, is underway, with it based on data collected from prior studies.
“We view the (US) fast track designation for our lead candidate, Nexvax2, as a testament to the significant need for bringing therapeutic solutions to patients with coeliac disease as quickly as possible,” Chief Executive Officer of ImmusanT Leslie Williams said.
“Currently there are no disease-modifying therapies for this condition, and the only solution for patients is strict adherence to a lifelong, gluten-free diet.”
WEHI’s Dr Jason Tye-Din and chief scientific officer at ImmusanT Dr Bob Anderson first begun their research on a vaccine for coeliac disease in 2003.
“The phase two trials build on the data from earlier studies and it is great that Australia is still playing a pivotal role in this work,” Dr Tye-Din said.
While initial regulatory phases have been promising, the progress of the vaccine through the FDA may be slowed due to the partial US government shutdown.
If you are hoping to partake in the trial studies or seeking further information about WEHI’s research, visit the institute’s website here.