Melbourne-based Aravax today announced positive results from the Phase I trial of its peanut allergy therapy, at the 2019 American Academy of Allergy, Asthma and Immunology (AAAAI) Annual Meeting in San Francisco. The trial data showed that Aravax’s therapy has a highly favorable safety profile, even in patients with severe peanut allergies.

“Peanut allergy is the most common cause of food allergy-related deaths in children, and there is an urgent need for safe, effective and convenient therapies that address the underlying cause of this potentially fatal disease,” said Pascal Hickey, CEO of Aravax.

Almost two in every hundred Australians suffer from peanut allergy, and currently there is no therapy to reduce the severity of allergic reactions that can occur following accidental consumption. Despite patients attempting to follow a peanut-free diet, every year around 40% of peanut allergic individuals will suffer a serious adverse event from inadvertent exposure, including anaphylaxis which can lead to death.

Traditionally, allergy specialists have treated patients using repeat doses of the allergy-causing substance. Similar approaches are being developed to treat peanut allergy, but the use of therapies containing whole peanut protein carries a high risk of severe reactions and requires daily dosing for lengthy periods.

As part of Aravax’s Phase I trials carried out over the past 18 months at CMAX Clinical Research in Adelaide and Nucleus Network in Melbourne, Aravax evaluated the safety and tolerability of its product known as PVX108 through single and repeated administration across a range of doses.

The Phase I results are significant as compared with other immunotherapeutic approaches to peanut allergy, Aravax’s product does not contain the parts of peanut protein that cause severe allergic reactions, and its once-a-month dosing regimen is a far simpler solution than taking medication every day.

“We believe that this therapy has important potential to improve the lives of millions of people with peanut allergies. The results from our Phase I clinical trial demonstrate that our peptide-based immunotherapy approach has a positive safety profile, so now we are working with the clinical community to design a Phase II study of PVX108, which will be conducted in Australia and the United States,” Dr Hickey said.

Aravax’s technology is underpinned by more than a decade of research led by Professor Robyn O’Hehir and her team at Alfred Health and Monash University, which has been supported by the Australian Food Allergy Foundation, the Alfred Hospital Trust, and the National Health and Medical

Research Council. In 2015, Aravax secured over $4.85 million in investment from the Medical Research Commercialisation Fund (MRCF) to develop the technology through to initial clinical trials.

Professor Robyn O’Hehir, Professor and Head of Department of Respiratory Medicine, Allergy and Clinical Immunology, Central Clinical School, Monash University and Chief Medical Advisor to Aravax also discussed the data during an AAAAI press conference over the weekend.

“Although early-stage, these results suggest that a peptide-based approach to peanut allergy immunotherapy could offer significant safety advantages over other approaches in later stages of development,” said Professor O’Hehir. “This is a significant breakthrough in the search for a safe therapy for peanut allergy, and builds on prior work showing that PVX108 targets the peanut-specific T cells that are believed to be the underlying cause of disease.”

Aravax’s Phase I results, “Safety and Tolerability of a Novel Peptide-Based Immunotherapy for Peanut Allergy” will be presented at the AAAAI Annual Conference at 9:45 a.m. PST on Monday, February 25th.