This article is part of MPR‘s coverage of the American Academy of Allergy, Asthma & Immunology annual meeting, taking place in San Francisco, California. Our staff will report on medical research related to asthma, allergy, and other respiratory conditions, conducted by experts in the field. Check back regularly for more news from AAAAI 2019.
SAN FRANCISCO — PVX108, a peptide-based immunotherapy in development for the treatment of peanut allergy, demonstrated a favorable safety profile according to data from a phase 1 clinical trial presented at the American Academy of Allergy, Asthma & Immunology (AAAAI) held February 22-25 in San Francisco.
PVX108 is a mixture of short, synthetic peptides derived from sequences of major peanut allergens designed to build tolerance specifically to peanut proteins, and formulated for intradermal injection. Researchers assed the safety and tolerability of PVX108 in adults with peanut allergy in a randomized, double-blind placebo-controlled phase 1 trial. Participants were randomly assigned to receive PVX108 or placebo; 8 cohorts received a single injection and then the dose was escalated for each successive cohort once the previous cohort had safely completed their dose. The ninth cohort received 6 injections at the highest dose (150nmol) over the course of 16 weeks.
Whole blood from 146 peanut-allergic donors was incubate with negative and positive controls and a range of doses of peanut extract and PVX108. The researchers used flow cytometry to analyze the percentage of activated basophils from 600 basophilic events. Basophil assays confirmed a lack of basophil reactivity to PVX108 vs peanut extract. A total of 66 participants were enrolled in the trial and none experienced any serious adverse events. Those that were experienced were categorized as mild or moderate with the majority being related to injection site reactions.
According to these findings, the researchers believe that PVX018 is a promising novel immunotherapy for peanut allergy with a low likelihood of triggering acute allergic reactions. It was well tolerated by adults with peanut allergy, including patients with previous anaphylaxis episodes and asthma.
A phase 2 clinical trial involving children is currently being planned.
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Prickett SR, Hickey PLC, Bingham J, et al. Safety and tolerability of a novel peptide-based immunotherapy for peanut allergy. Presented at: American Academy of Allergy, Asthma & Immunology annual meeting 2019; February 22-25, 2019; San Francisco, CA. Abstract L31.