Novel monoclonal antibody combination appears active against birch allergy symptoms
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A single dose of the novel antibody combination, REGN5713/14/15, appeared well-tolerated and demonstrated rapid and sustained inhibition of birch allergy symptoms, according to phase 1 study results.
“Birch allergy is a main driver of seasonal allergic rhinitis,” study researcher Meagan O’Brien, MD, senior medical director of early clinical development and clinical experimental sciences at Regeneron Pharmaceuticals Inc., told Healio. “In Europe and the United States, clinically relevant sensitization to birch pollen affects approximately 20% to 30% of the allergic population.”
REGN5713/14/15 (Regeneron Pharmaceuticals Inc.) contains Bet v 1 — the immunodominant and most abundant allergenic protein in birch pollen.
The randomized, double-blind, placebo-controlled, two-part, phase 1 study included 96 participants. Part A of the study assessed REGN5713/14/15 in ascending doses from 150 mg up to 900 mg among 32 healthy adults recruited from a single study site. In part B, researchers assessed one subcutaneous 900 mg dose of the combination vs. placebo among 64 individuals with birch allergy from three study sites in Belgium.
Researchers assessed total nasal symptom score response to titrated birch extract nasal allergen challenge and skin prick test with birch and alder allergen at baseline and again on days 8, 29 and 57 as well as on day 113 with skin prick test only. An additional 26 individuals underwent basophil activation tests.
Results, published in Journal of Allergy and Clinical Immunology, showed that the combination significantly prevented nasal allergy symptoms following a nasal provocation with birch allergen. The effect occurred as early as day 8 (area under the curve, –1.17; P = .001). Researchers reported an AUC of –1.18 on day 29 (P = .001) and –0.85 on day 57 (P = .024).
Additionally, response of the skin prick test to birch allergen after treatment with REGN5713/14/15 was significantly reduced at each time point evaluated during the study compared with placebo (all P < .001) and up to approximately 4 months.
Participants treated with REGN5713/14/15 also showed significantly reduced basophil responsiveness to birch-related allergens on days 8, 57 and 113 compared with participants who received placebo (all P < .01).
Researchers also noted the treatment was well-tolerated, with no serious adverse events reported in either part of the study.
“This study demonstrates the effect of a novel investigational therapeutic for the treatment of allergic rhinitis symptoms due to birch pollen,” O’Brien said. “This treatment results in a response as early as day 8 and persists during a time period that is expected to cover a typical birch pollen season. Regeneron Pharmaceuticals Inc. is currently conducting a phase 3 trial evaluating this monoclonal antibody combination in a real-world setting during the 2021 birch pollen allergy season.”
For more information:
Meagan O’Brien, MD, can be reached at Regeneron Pharmaceuticals Inc., 777 Old Saw Mill River Road, Tarrytown, NY 10591.