13th January 2018, California, United States of America – Australian biotechnology company Aravax presented preliminary data from the first Phase I clinical trial of its product known as PVX108 at the Gordon Research Conference on Food Allergy at Ventura Beach in California, held from the 7th-12th January 2018. The Gordon Research Conference brought together leading researchers, clinicians, regulatory and industry representatives from around the world who are working towards revolutionising the standard of clinical care for sufferers of food allergies.
Aravax’s Phase I clinical trial AVX-001 is a two stage, randomised, double blind, placebo-controlled study to evaluate the safety and tolerability of single and repeated administration of PVX108 in peanut allergic adults. Stage 1 is a single ascending dose study in 8 cohorts of 6 subjects randomised 2:1 active: placebo. Stage 2 is a multiple dose regimen with a total of 18 subjects randomised 2:1 active: placebo. Subjects will receive a total of 6 doses over 16 weeks. A safe starting dose for Stage 2 will be determined following review of safety and tolerability of single doses in Stage 1. AVX-001 commenced dosing in May 2017 and completed dosing in Stage 1 in December 2017. Stage 2 will commence dosing in January 2018. The trial is being conducted at the CMAX Clinical Research in Adelaide and at Nucleus Network in Melbourne.
The preliminary blinded data from Stage 1 of AVX-001 presented at the Gordon Research Conference demonstrated that Aravax’s product has a highly favourable safety profile for the treatment of sufferers of peanut allergies, including those with severe peanut allergies. There were no serious adverse events or adverse events of clinical concern in any of the 48 subjects who received a single dose of PVX108 or placebo, with PVX108 doses ranging from 0.05 nmol to 150 nmol. These data suggest that Aravax has met its objective to develop a novel immunotherapy for peanut allergy with a greatly reduced potential to trigger acute allergic reactions. The Safety Review Committee confirmed the acceptable safety and tolerability of single doses of PVX108 in Stage 1 and approved commencement of the planned multidose regimen in Stage 2.