Australian company Aravax has announced that the first patient has been dosed in its Phase 2 study (AVX-201) of investigative candidate PVX108 for the treatment of peanut allergy.
The study is being conducted under a US FDA Investigational New Drug Application.
Allergy clinical trial centres across Victoria, South Australia, New South Wales, and Western Australia have invited children and adolescents aged four to 17 years with peanut allergy to participate in the study.
The company said that in Phase 1 trials, researchers observed that PVX108 produced relevant changes in the immune response to peanut protein, which continued to develop once dosing had been completed.
“We’re thrilled to have dosed our first patient in Phase 2. In this Phase 2 trial we will evaluate how the immunological changes observed in Phase 1 trials translate to clinical reductions in allergic reactivity and the development of tolerance to peanuts following 12 monthly doses of PVX108,” said Aravax CEO Dr Pascal Hickey.
Unlike most treatments available or under development for peanut allergy, Aravax’s PVX108 does not contain peanut proteins, putting patients at risk of serious side effects. Aravax is applying its platform technology to develop specific immunotherapies for food allergies designed to retrain the immune system to tolerate peanut allergens precisely.
These therapies are anticipated to be highly differentiated based on greatly improved safety profiles and the potential for sustained clinical benefits, possibly leading to the reversal of allergic disease.
Clinical trial AVX-201 is led in Australia by regional principal investigator Associate Professor Kirsten Perrett, Population Allergy Group Leader at the Murdoch Children’s Research Institute. Associate Professor Perrett is also a Paediatric Allergist and Vaccinologist and Director of the National Allergy Centre of Excellence (NACE).
Aravax representatives will be attend BIO 2023 in Boston next week. Chief scientific officer Sara Prickett will also be speaking at the European Academy of Allergy and Clinical Immunology Congress 2023 (Hamburg, 9-11 June).
“I’m excited to be speaking at EAACI to some of the world’s top immunology experts about the great progress being made at Aravax to tackle peanut allergies, an issue that affects millions of people globally. I've seen the impact that peanut allergies not only have on patients, but also families,” said Prickett.
The Phase 2 trial PVX108 follows a $20 million series B funding round, led by Australian life science investors Brandon Capital and Tenmile.