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Regeneron’s Phase III trials show promising results for new antibody treatments, offering rapid and lasting relief from cat and birch allergies.
In two separate Phase III trials, single dosages of anti-body blockers displayed significant reductions in birch and cat allergy symptoms compared to their respective placebos.
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Regeneron Pharmaceuticals announced results from both of its allergen-challenge Phase III trials evaluating investigational allergen-blocking anti-bodies in adults with moderate-to-severe cat or birth allergies. Results from both trials yielded positive results with each trail meeting its primary and secondary endpoints.
George D. Yancopoulos, M.D., Ph.D., board co-chair, president and chief scientific officer at Regeneron, and a co-inventor of this new approach to allergy treatment, touched on the importance of the positive trial results, saying, “Millions suffer from the debilitating effects of allergies, which can cause severe symptoms in the eyes, nose, skin and even trigger asthma. To try to alleviate this suffering, millions undergo allergy desensitization shots, often several times a week for several years, and often with disappointing results. The purpose of these burdensome allergy shots is to try to build up allergen-blocking antibodies in the body. We wondered whether we could instead manufacture and directly provide allergen-blocking antibodies. These recent Phase 3 allergen challenge trials, together with our earlier Phase 2 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 programs.”1
In the Phase III trial participants with cat allergies were randomized and administered a single dose of the FelD1-blocking antibody combination therapy (REGN1908 and REGN1909, n=33) or placebo (n=31).1 The trial’s primary endpoint focused on ocular itch, along with both key secondary endpoints aimed at conjunctival redness and skin prick testing ,were assessed following one week of treatment of FelD1-blocking antibodies. The endpoints were marked with a high degree of statistical importance within the overall testing population, with itching being reduced 52%, conjunctival redness by 39%, and skin prick reactivity by 44%. 1 In a post-hoc exploratory analysis of participants with cat allergies driven by FelD1, results yielded improved reductions in both ocular itch (64%) and conjunctival redness (49%) compared to the overall population.
Trial results reflected a generally well-tolerated response to the combination therapy, with no serious treatment-related adverse events or adverse events leading to trial discontinuation. The trial is currently ongoing for further safety follow-up with additional Phase III development being planned to begin in the first half of 2026. 1
In Regeneron’s other Phase III trial, participants were randomized to receive a single dose of the BetV1-blocking antibody combination (REGN5713 and REGN5715, n=27) or placebo (n=27).1
The trial’s primary endpoint of ocular itch along with its key secondary endpoints of conjunctival redness and skin prick testing, were assessed one week after patients received a single treatment including BetV1-blocking antibodies. The birch-allergen trial endpoints exhibited results of 51% itch reduction, 46% decrease in conjunctival redness, and lowered skin prick reactivity by 44%
The combination therapy was generally well-tolerated, with no serious adverse events or adverse events leading to trial discontinuation. Regeneron is planned to begin Phase III development by the end of the year.1
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