Two companies are competing for a peanut therapy market that is said to be around $US3 billion. Both are seeking approval from US regulators to start selling their products, which aim to reduce the severity of peanut allergy reactions.
Phase 3 trial results for the wearable skin patch immunotherapy treatment Viaskin Peanut, were presented at the recent American College of Allergy, Asthma and Immunology Annual Scientific Meeting. Over 60 per cent of the young patients (aged 4 to 11 years) with peanut allergy treated with 250 µg of Viaskin Peanut tolerated an increased eliciting dose of peanut protein, compared with only 28 per cent of those who received placebo.
DBV Technologies filed for FDA approval of Viaskin Peanut in October to treat patients ages 4 to 11, with a decision expected in 2019.
The other company hoping to secure FDA approval for a peanut immunotherapy product is California-based Aimmune, which is developing AR101, a capsule of peanut protein that is mixed into food.
The peanut protein dose of AR101 starts at a very low level, and then increases over about six months to roughly the equivalent of one peanut kernel. Patients then continue on a maintenance dose at that level. Aimmune said 67 per cent of young peanut allergy sufferers (aged 4 to 17 years) who were administered AR101 in the Phase 3 trial could tolerate exposure of at least a 600-mg dose of peanut protein in the exit food challenge. Only 4 per cent of patients on the placebo could tolerate that amount.
As Aimmune prepares to apply for regulatory approval for its AR101 product before the end of 2018, Nestlé Health Science is said to have increased its financial stake in the company to achieve 19 per cent ownership. If AR101 is approved, it is projected to earn around $1.3 billion per year by 2025.
Meanwhile, Australian biotechnology company Sementis recently announced a collaboration with UK-based Enesi Pharma, focused on the development and evaluation of a peanut allergy vaccine. However, the product is only expected to enter Phase 1 trials in 2019. Another Australian company, Aravax, is nearing completion of the Phase 1 clinical trial of its leading peanut allergy vaccine candidate.
Green T, et al. Increased reactivity threshold in peanut-allergic subjects treated with 12 months of epicutaneous Viaskin peanut. Presented at: American College of Allergy, Asthma and Immunology Annual Scientific Meeting; Nov. 15-19, 2018; Seattle.