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Also known as Bremzalerbart
REGN5713 · 3 trials · 3 indications
Assessed using the Ora Calibra® Conjunctival Allergen Challenge Ocular Itching Scale, a 0-4 point scale where 0 = none and 4= incapacitating itch, 0.5 unit increments
The average CSMS will be calculated based on daily symptom score and daily medication score recorded over the duration of the birch pollen season (BPS). CSMS is calculated by adding the Daily Medication Score (DMS) and Total Symptom Score (TSS) together, with scores ranging between 0 (none) and 38 (severe).
TNSS ranges from 0 (none) to 12 (severe): sum of 4 nasal symptoms (nasal congestion, itching, \& runny nose, \& sneezing) graded on a Likert scale ranging from 0 (none) to 3 (severe); Higher score indicates worse outcome.
| Arm | Type | Description |
|---|---|---|
| REGN5713-5715 | EXPERIMENTAL | Participants will be randomized 1:1 |
| Placebo | PLACEBO_COMPARATOR | Participants will be randomized 1:1 |
| REGN5713-5714-5715 | EXPERIMENTAL | REGN5713-5714-5715 administered subcutaneously |
| Placebo Only | PLACEBO_COMPARATOR | Placebo matching REGN5713-5714-5715 administered subcutaneously |
| REGN5715 | EXPERIMENTAL | 1-mAb |
| Matching Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| REGN5713 | DRUG | Administered per protocol |
| REGN5715 | DRUG | Administered per protocol |
| Placebo | DRUG | Administered per protocol |
| REGN5714 | DRUG | Administered subcutaneously |
Key Inclusion Criteria: 1. Documented or participant-reported history of moderate to severe birch pollen allergy for at least 2 years with bothersome ocular symptoms during the birch season 2. Positive SPT to birch allergen extract, as described in the protocol 3. Positive allergen specific immunog...
REGN5713 is being developed for allergic conjunctivitis and allergic rhinitis, conditions triggered by exposure to birch pollen. It is an investigational therapy studied in adults with birch pollen allergy. Regeneron Pharmaceuticals is evaluating it in Phase 3 clinical development, with completed trials in the United States, Canada, and several European countries.
REGN5713 targets Bet v 1 (BetV1), the major birch pollen allergen, which belongs to the allergen target class. By binding this allergen, the therapy is designed to reduce allergic rhinitis and conjunctivitis symptoms and skin test reactivity following birch allergen exposure. It is a small molecule administered subcutaneously in the clinical studies.
Regeneron Pharmaceuticals, Inc. (ticker: REGN) is developing REGN5713. The company has sponsored Phase 2 and Phase 3 trials of the candidate in adults with birch pollen allergy, evaluating its effect on allergic rhinitis and conjunctivitis symptoms.
REGN5713 is in Phase 3 clinical development. It is investigational and has not been approved by the FDA. Regeneron has completed Phase 2 and Phase 3 studies of the candidate, including a Phase 3 trial in allergic conjunctivitis and a Phase 3 trial in seasonal allergic rhinitis.
REGN5713 has been studied in completed trials including NCT06602739, a Phase 3 study in adult participants with birch pollen allergy and allergic conjunctivitis, and NCT04709575, a Phase 3 study in adults with seasonal allergic rhinitis. A Phase 2 trial, NCT05430919, evaluated anti-Bet v 1 monoclonal antibodies in allergic rhinitis and conjunctivitis.
REGN5713-5715 refers to the combination studied in the Phase 3 trial NCT06602739, which evaluated the effect of REGN5713-5715 on reducing ocular allergy signs and symptoms in adults with birch pollen allergy. REGN5713 is the anti-Bet v 1 antibody component referenced across the clinical program.