Regeneron Pharmaceuticals’ first-in-class investigational allergen-blocking monoclonal antibodies (mAbs) met their primary endpoints in two Phase III trials in adults with moderate-to-severe cat or birch allergies.
In the cat allergen trial, patients received a single dose of REGN1908 and REGN1909, or a placebo. The primary endpoint of ocular itch and both key secondary endpoints of conjunctival redness and skin prick testing – assessed one week after the single treatment with FelD1-blocking antibodies – were met, with itch reduced by 52%, conjunctival redness by 39% and skin prick reactivity by 44%.
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In patients whose allergy was more driven by FelD1, a protein which the drugs target, the reaction was higher, with ocular itch reduction of 64% and conjunctival redness reduction of 49%. As a result, Regeneron said this will be the patient population evaluated in the confirmatory trials.
The combination therapy was generally well-tolerated, with no serious treatment-related adverse events or adverse events leading to trial discontinuation reported.
Meanwhile, in the birch-allergen study, the combination of REGN5713 and REGN5715, two mAbs targeting and blocking BetV1, reduced itching by 51%, conjunctival redness by 46%, and skin prick reactivity by 44%.
The combination therapy was generally well-tolerated, with no serious adverse events or adverse events leading to trial discontinuation.
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By GlobalDataThe cat and birch allergy programmes are part of a broader allergy pipeline at Regeneron, which also includes an ongoing proof-of-concept trial in adults with severe food allergy. If successful, the food allergy therapy will enter a fast-growing market with GlobalData analysts forecasting the food allergy market to reach $2.7bn by 2030 from $213.9m in 2020.
GlobalData is the parent company of Clinical Trials Arena.
This study involves ablating the cells making the IgE antibodies that initiate the allergen response, followed by ongoing treatment with Sanofi and Regeneron’s Dupixent (dupilumab) to prevent the return of these cells.
Regeneron president and chief scientific officer Dr George Yancopoulos said: “These recent Phase III allergen challenge trials, together with our earlier Phase II trials, provide compelling evidence that our first-in-class approach can have the potential to provide profound allergy relief – rapidly and durably after a single treatment – decreasing ocular, nasal and even asthma measures.
“We see significant relief at the earliest assessment timepoint, and lasting for over three months, in both our cat and birch allergy programmes.”
The birch allergy confirmatory trial is due to begin by the end of 2025, and the confirmatory cat allergy trial in H1 2026.
