Aravax doses first patient in Phase 2 peanut allergy clinical trials
June 2, 2023
The first patient has been dosed in a Phase 2 study (AVX-201) being run by biotechnology company Aravax, which is developing the novel therapy PVX108 for the safe and convenient treatment of peanut allergy. The study is being conducted under a U.S. 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 take part in the Phase 2 study. Researchers aim to evaluate the efficacy of the novel therapy PVX108.
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 completed.
“We’re thrilled to have dosed our first patient in Phase 2. In this trial we will evaluate how the immunological changes observed in Phase 1 trials translate to clinical reductions in allergic reactivity following 12 monthly doses of PVX108. We will also look for sustained unresponsiveness to peanuts, an important indicator for the development of tolerance to peanuts.,” says Dr Pascal Hickey, CEO, Aravax.
Unlike most treatments available or under development for peanut allergy, Aravax’s PVX108 does not contain peanut proteins which put patients at risk of serious side effects. Aravax is applying its platform technology to develop specific immunotherapies for food allergies which are designed to precisely retrain the immune system to tolerate peanut allergens.
These therapies are anticipated to be highly differentiated based on greatly improved safety profile, and the potential for sustained clinical benefits possibly leading to 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 will be attending BIO 2023 in Boston next week, and, Chief Scientific Officer Sara Prickett will be speaking at the European Academy of Allergy & Clinical Immunology Congress 2023 (Hamburg, 9-11 June), in a presentation titled: ‘A Peptide Immunotherapy for Peanut Allergy Safely Induces Durable Immune Changes in Peanut-Allergic Adults’.
“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,” Prickett says.
Most allergic reactions to peanuts are mild like swelling of the lips or hives, but even “mildly allergic” children can go on to have a severe reaction without warning. This creates significant anxiety, and many families have to make significant lifestyle adjustments to manage this risk which can leave children feeling excluded from day-to-day activities.
A therapy which safely and conveniently reduces the risk of severe reactions to peanuts has the potential to transform the outlook for many families living with peanut allergy.
Aravax’s Phase 2 trials of PVX108 follow on from $20m investment as part of its series B funding round, led by Australian life science investors, Brandon Capital and Tenmile.
More information and details on how to apply to participate in the clinical trial can be found on the on the NACE and Aravax websites.
Note to Editors:
For further information or to arrange an interview, please contact:
Joel MacManus, Mana Communications, email@example.com, +64 27 427 3283
Aravax is a clinical stage biotechnology company focused on revolutionising the treatment of food allergies with next-generation specific immunotherapies which are safe, effective and convenient. Aravax applies proprietary technology and know-how to design highly targeted pharmacotherapies, which reset the immune system to tolerate a specific allergen without evoking allergic reactions during treatment. The lead product, PVX108, is being developed for the treatment of peanut allergy. Aravax is headquartered in Melbourne, Australia, and was founded in 2015 with venture capital from Brandon Capital and technology from Alfred Health and Monash University.
For more information visit: www.aravax.com.au
About Aravax’s Phase 2 trial
AVX-201 is a double-blind randomised Phase 2 study in adolescents and children with peanut allergy. The aims of the trial are to evaluate the efficacy and safety of PVX108 when administered intradermally in monthly doses over a 12-month period. The trial is being conducted under an US FDA IND at sites in Australia and in the United States.
For more information visit: Clinical Trials for Aravax.