Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
REGN5713 · 4 trials · 3 indications
Assessed using the Ora Calibra® Conjunctival Allergen Challenge Ocular Itching Scale, a 0-4 scale where 0 = none and 4= incapacitating itch, 0.5 unit increments
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 | - |
| REGN5713 | EXPERIMENTAL | - |
| REGN5715 | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| REGN5713-5714-5715 | EXPERIMENTAL | REGN5713-5714-5715 administered subcutaneously |
| Placebo Only | PLACEBO_COMPARATOR | Placebo matching REGN5713-5714-5715 administered subcutaneously |
| 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. Positive SPT to birch allergen extract 2. Positive allergen specific Immunoglobulin E (sIgE) tests for birch and Bet v 1 3. Positive CAC criteria Key Exclusion Criteria: 1. Significant and/or severe environmental allergies causing symptoms (outside of the challenge sett...
REGN5713 is an investigational small molecule being developed by Regeneron Pharmaceuticals for allergic conjunctivitis and allergic rhinitis caused by birch pollen allergy. It is designed to reduce symptoms of seasonal allergic rhinitis and ocular allergy signs in adults and adolescents. The drug is currently in Phase 3 clinical development.
REGN5713 targets Bet v 1, the major allergen in birch pollen. As an anti-Bet v 1 monoclonal antibody, it binds to this allergen to reduce allergic responses. The drug is being studied for its ability to lessen symptoms of allergic rhinitis and conjunctivitis upon exposure to birch allergen.
REGN5713 is being developed by Regeneron Pharmaceuticals, Inc., a biopharmaceutical company traded on NASDAQ under the ticker REGN. Regeneron is conducting clinical trials to evaluate the drug's efficacy in treating allergic rhinitis and conjunctivitis associated with birch pollen allergy.
REGN5713 is in Phase 3 clinical development for allergic conjunctivitis and allergic rhinitis. It is an investigational drug and has not been approved by regulatory authorities. The development program includes completed Phase 2 and Phase 3 trials, with additional studies ongoing or recently completed.
REGN5713 has been studied in several clinical trials. NCT04709575 was a Phase 3 study in adults with seasonal allergic rhinitis. NCT05430919 was a Phase 2 trial in Canada. NCT06602739 was a Phase 3 study for ocular allergy signs, and NCT07309432 was a Phase 3 trial in adolescents and adults, though it was terminated.
REGN5713 is often studied in combination with REGN5715, another anti-Bet v 1 antibody. Clinical trial NCT06602739 evaluated the effect of REGN5713-5715 on reducing ocular allergy symptoms. While they are separate antibodies, they are frequently administered together in studies for birch pollen allergy.