New Phase One Peanut Allergy Immunotherapy Trial Results in no Severe Side Effects, Including Anaphylaxis
Research presented at 2019 AAAAI Annual Meeting details phase one study of peptide-based immunotherapy, which is designed to remove risks of acute reactions during treatment
San Francisco, CA – New phase one data has demonstrated PVX108, a peptide-based immunotherapy for peanut allergy, has a highly favorable safety profile, even for patients with severe peanut allergies.
Presented for the first time at the 2019 Annual Meeting of the American Academy of Allergy, Asthma & Immunology (AAAAI), the study graded all adverse reactions to PVX108 mild or moderate. Severe reactions to immunotherapy is a substantial barrier for patients, making the results of this new treatment even more significant.
PVX108 stands out by utilizing peptides that have been carefully selected from peanut proteins to induce tolerance to peanuts. By allowing these peptides to interact with immune cells, in the absence of whole protein which causes inflammation in allergic patients, those immune cells causing allergies may be reprogrammed to tolerate the allergen. The peptides are designed to be incapable of activating mast cells and basophils, so the risk of PVX108 causing severe reactions (including anaphylaxis) during treatment is greatly reduced.
The first stage of the study assessed single, ascending doses of PVX108 and enrolled eight cohorts of six subjects each. Subjects of each cohort were randomized to receive PVX108 or the placebo. Cohorts were enrolled one at a time, starting with a single injection. Once it was determined the cohort had safely tolerated the injection, the next cohort received an injection of a slightly higher dose. The dose escalated for each successive cohort, with the eighth cohort receiving the highest dose. In the second stage of the study, a ninth cohort of 18 subjects was randomized to receive multiple (six) injections at the same dose level delivered over a 16 week period.
The majority of adverse reactions reported were related to the injection site and typical of those seen in a phase one study. None of the reactions were deemed to be of clinical concern according to the study’s Safety Review Committee. The frequency and severity of adverse reactions appeared unrelated to dose levels or frequency of dose.
“This is an exciting time for clinicians who treat patients with peanut allergies as we now have several approaches being evaluated to treat this potentially life-threatening condition,” said Professor Robyn O’Hehir, MD, PhD, Director of the Department of Respiratory Medicine, Allergy and Clinical Immunology (Research), Central Clinical School, at Monash University in Melbourne, Australia. “In particular, we are extremely encouraged by the favorable safety profile observed for PVX108 in this first clinical study of a peptide immunotherapy in peanut-allergic patients. In contrast to traditional specific immunotherapies which rely on exposing patients to allergenic proteins and carry the risk of dangerous side effects including anaphylaxis, PVX108 has been formulated to comprise only the small peptide components of peanut protein that are believed to be critical for inducing tolerance in T cells. The peptides are synthesized to high quality standards and precisely target the underlying cause of disease. PVX108 does not contain whole peanut protein, so can be administered safely without dose escalation. While still early, the data suggest that monthly intradermal injections of PVX108 could transform how we treat patients with peanut allergies, including those with severe allergy.”
Visit aaaai.org to learn more about food allergies. Research presented at the AAAAI Annual Meeting, February 22-25 in San Francisco, California, is published in an online supplement to The Journal of Allergy and Clinical Immunology.
The American Academy of Allergy, Asthma & Immunology (AAAAI) represents allergists, asthma specialists, clinical immunologists, allied health professionals and others with a special interest in the research and treatment of allergic and immunologic diseases. Established in 1943, the AAAAI has nearly 7,000 members in the United States, Canada and 72 other countries. The AAAAI’s Find an Allergist/Immunologist service is a trusted resource to help you find a specialist close to home.