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Clinical Trial Begins for Peanut Allergy Treatment

Bag of peanuts

(Radu Marcusu, Unsplash)

1 June 2023. A clinical trial is underway testing an experimental therapy for peanut allergy that its developer says trains the immune system without using peanut proteins. The study is sponsored by Aravax Pty. Ltd. in Melbourne, Australia that designed a treatment for adjusting immune-system responses in people with peanut allergies before immune cells react directly to allergens in peanuts.

Aravax is a biotechnology enterprise whose sole business is peanut allergy therapies. The company’s technology is based on immunology research at Monash University in Melbourne seeking alternatives to most other peanut allergy treatments that train the immune system to accept allergy-inducing proteins in peanuts. The therapies work with small escalating doses of peanut proteins to desensitize reactive immune-system cells and limit or stop release of histamines that cause inflammatory responses. Those responses can range from mild itching to life-threatening anaphylaxis.

Aravax says the technology in its lead product code-named PVX108 targets T-cells that regulate and balance reactions by other immune system cells responding directly to allergens, in this case allergy-inducing peanut proteins. The company says it uses peptides, short chains of amino acids, that interact with T-cells to adjust their normally reactive responses to offending allergens. When people with peanut allergies are exposed to a series of these peptide treatments, says Aravax, their immune systems learn to accept peanuts, but without using peanut proteins that can cause adverse effects in some cases.

Changes in peanut-specific indicators

The company tested PVX108 in an early-stage clinical trial with adults having peanut allergies. The study exposed participants to escalating doses of PVX108 or a placebo over 16 weeks, with the study team looking primarily for adverse effects. A follow-up study tracked participants over 18 months taking blood samples for changes in biomarkers or molecular indicators of changes in their immune systems. Aravax says the trial shows PVX108 is safe and well-tolerated, including among participants with asthma, and after one year induces changes in peanut-specific cellular and antibody indicators.

The new trial is a mid-stage study enrolling 90 children and adolescents, age 4 to 17, in Australia with peanut allergies. Participants are randomly assigned to receive one dose of PVX108 or a placebo every four weeks as an injection under the skin for one year, with low and higher doses tested among younger children. All participants are given supervised peanut challenges before and after treatment, and are tracked for up to 74 weeks.

The study team is looking mainly at the maximum amount of peanut protein participants can tolerate after treatments with PVX108 at week 46, compared to the beginning of the trial. The researchers are also monitoring participants for adverse effects from the treatments, particularly severe effects, and several other health indicators. The company says it plans to expand the trial to sites in the U.S. by the end of the year.

Aravax’s chief scientist Sara Prickett, one of the original academic researchers behind the company’s technology, is speaking about PVX108 at the European Academy of Allergy and Clinical Immunology Congress in Hamburg, Germany later this month. Prickett says in a company statement released through Cision, she expects to talk about the “progress being made at Aravax to tackle peanut allergies, an issue that affects millions of people globally.” She adds, “I’ve seen the impact that peanut allergies not only have on patients, but also families.”

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