Positive trial results for peanut allergy therapy
Melbourne-based biotech company Aravax has announced positive results from the Phase I trial of its peanut allergy therapy. Presented 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 favourable safety profile, even in patients with severe peanut allergies.
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.
Compared with other immunotherapeutic approaches to peanut allergy, Aravax’s product (known as PVX108) does not contain the parts of peanut protein that cause severe allergic reactions, and its once-a-month dosing regimen is a simpler solution than taking medication every day. The 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.
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. Its Phase I trials, carried out over the past 18 months at CMAX Clinical Research in Adelaide and Nucleus Network in Melbourne, saw Aravax evaluate the safety and tolerability of PVX108 through single and repeated administration across a range of doses.
“The results from our Phase I clinical trial demonstrate that our peptide-based immunotherapy approach has a positive safety profile,” said Aravax CEO Pascal Hickey. “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.”
“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,” Prof O’Hehir said. “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.”
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