REGN5713-5714-5715 / Regeneron - LARVOL DELTA

Efficacy of the Anti-Bet v 1 Monoclonal Antibodies (Given Subcutaneously) to Reduce Allergic Rhinitis and Conjunctivitis Symptoms and Skin Test Reactivity Upon Exposure to Birch Allergen in Adult Participants (clinicaltrials.gov) - P2 | N=218 | Completed | Sponsor: Regeneron Pharmaceuticals | Active, not recruiting ➔ Completed

Trial completion • Allergic Rhinitis • Conjunctivitis • Immunology • Inflammation • Ocular Infections • Ocular Inflammation • Ophthalmology

Efficacy of the Anti-Bet v 1 Monoclonal Antibodies (Given Subcutaneously) to Reduce Allergic Rhinitis and Conjunctivitis Symptoms and Skin Test Reactivity Upon Exposure to Birch Allergen in Adult Participants (clinicaltrials.gov) - P2 | N=218 | Active, not recruiting | Sponsor: Regeneron Pharmaceuticals | Recruiting ➔ Active, not recruiting

Enrollment closed • Allergic Rhinitis • Conjunctivitis • Immunology • Inflammation • Ocular Infections • Ocular Inflammation • Ophthalmology

Efficacy of the Anti-Bet v 1 Monoclonal Antibodies (Given Subcutaneously) to Reduce Allergic Rhinitis and Conjunctivitis Symptoms and Skin Test Reactivity Upon Exposure to Birch Allergen in Adult Participants (clinicaltrials.gov) - P2 | N=300 | Recruiting | Sponsor: Regeneron Pharmaceuticals | Not yet recruiting ➔ Recruiting

Enrollment open • Allergic Rhinitis • Conjunctivitis • Immunology • Inflammation • Ocular Infections • Ocular Inflammation • Ophthalmology

Efficacy of Anti-Allergen Therapeutics in a Preclinical Model of Allergic Anaphylaxis Correlates with Symptomatic Relief in Allergic Patients (EAACI 2022) - "Blockade of individual mAbs versus mAb cocktails confirms optimal blocking efficacy of Fel d 1 mAb cocktail (REGN1908-1909) compared with either single mAb; Bet v 1 triple mAb cocktail (REGN5713-5714-5715) compared with single mAb (REGN5715) or dual mAb cocktail (REGN5713-5715). Conclusion Blockade of mast cell degranulation in the PCA mouse model correlates to efficacy in clinical settings, validating the model as a useful tool for selection of efficacious anti-allergen therapeutics."

Preclinical • Allergy • Immunology

Efficacy of the Anti-Bet v 1 Monoclonal Antibodies (Given Subcutaneously) to Reduce Allergic Rhinitis and Conjunctivitis Symptoms and Skin Test Reactivity Upon Exposure to Birch Allergen in Adult Participants (clinicaltrials.gov) - P2 | N=300 | Not yet recruiting | Sponsor: Regeneron Pharmaceuticals

New P2 trial • Allergic Rhinitis • Conjunctivitis • Immunology • Inflammation • Ocular Infections • Ocular Inflammation • Ophthalmology

Study to Assess the Efficacy of Anti-Bet v 1 Monoclonal Antibodies in Adults to Reduce Symptoms of Seasonal Allergic Rhinitis (clinicaltrials.gov) - P3; N=353; Completed; Sponsor: Regeneron Pharmaceuticals; Active, not recruiting ➔ Completed

Clinical • Trial completion • Allergic Rhinitis • Conjunctivitis • Immunology • Ocular Infections • Ocular Inflammation • Ophthalmology

Study to Assess the Efficacy of Anti-Bet v 1 Monoclonal Antibodies in Adults to Reduce Symptoms of Seasonal Allergic Rhinitis (clinicaltrials.gov) - P3; N=353; Active, not recruiting; Sponsor: Regeneron Pharmaceuticals; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • Allergic Rhinitis • Conjunctivitis • Immunology • Ocular Infections • Ocular Inflammation • Ophthalmology

A study to investigate the efficacy of Anti-Bet v 1 Monoclonal Antibodies in reducing symptoms of seasonal allergic rhinitis (clinicaltrialsregister.eu) - P3; N=300; Ongoing; Sponsor: Regeneron Pharmaceuticals, Inc.

Clinical • New P3 trial • Allergic Rhinitis • Allergy • Immunology • Respiratory Diseases

[VIRTUAL] ANTI-BET V_1 MAB COCKTAIL REDUCED BIRCH ALLERGIC SYMPTOMS WITHIN ONE WEEK, SUSTAINED OVER TWO MONTHS (ACAAI 2020) - P1 | "Subjects had to achieve a TNSS (range 0-12) of >= 7 during NAC up-titration at screening to enter the study.Results Single-dose of REGN5713-5714-5715 significantly reduced TNSS following NAC relative to pre-dose baseline difference in TNSS AUC (0-1 hr) vs placebo (Day 8: −1.17, P=0.001; Day 29: -1.18, P=0.001; Day 57: -0.85, P=0.024) and titration SPT difference in AUC of mean wheal diameters vs placebo (Day 8: −2.54; Day 29: -2.27; Day 57: -2.78; Day 113: -2.46; all P<0.001), sustained for ≥2 months. REGN5713-5714-5715 is well-tolerated with treatment-emergent adverse events occurring at similar rates in treatment and placebo arms.Conclusion A single dose of a novel anti-Bet v_1 monoclonal antibody cocktail was well-tolerated and reduced birch allergic symptoms after birch allergen nasal provocation, potentially offering a new paradigm for the treatment of birch allergy."

Allergic Rhinitis • Allergy • Immunology

[VIRTUAL] ANTI-BET V_1 MABS REDUCED BASOPHIL RESPONSIVENESS TO BIRCH POLLEN STIMULATION EX-VIVO IN BIRCH ALLERGIC PATIENTS (ACAAI 2020) - "Introduction a single dose of anti-Bet v_1 mAb cocktail (REGN5713-5714-5715) for treating birch allergy has previously shown effectiveness by reducing both nasal allergen challenge (NAC) symptoms and titration skin prick test (SPT) in a randomized, double blinded, placebo-controlled study (N=64)...Inverse correlation also existed between percent change in TNSS(0-1hr) AUC and EC50 for birch allergen on Day 8 (r=-0.71, p=0.0095).Conclusion The clinical efficacy of anti-Bet v 1 mAb cocktail in treating birch allergy may be explained by the suppression of basophil and mast cell mediated allergic response. Allergic response to alder and hazel may also be suppressed during treatment."

Allergy • Immune Modulation • Immunology • Inflammation

Study to Assess the Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Effects of a Single Dose of REGN5713-5714-5715 in Healthy Adult Participants (clinicaltrials.gov) - P1; N=96; Completed; Sponsor: Regeneron Pharmaceuticals; Active, not recruiting ➔ Completed

Clinical • Trial completion • Allergy • Immunology

Targeting birch allergy with monoclonal IgG antibodies that bind allergen and prevent IgE effector cell activation (AAAAI 2020) - "These data confirm the immunodominance of Bet v 1 in birch allergy and suggest that maximal blockade may be achieved with REGN5713-5714-5715. X-ray crystal structure data show simultaneous binding of REGN5713 and REGN5715 with more than half the surface area of Bet v 1 exposed. REGN5714 binds this exposed region, but cannot cover all of it, suggesting that masking 100% of the surface is not required to achieve maximal blocking potency."

Study to Assess the Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Effects of a Single Dose of REGN5713-5714-5715 in Healthy Adult Participants (clinicaltrials.gov) - P1; N=96; Active, not recruiting; Sponsor: Regeneron Pharmaceuticals; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed