Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BDP · 2 trials · 1 indication
Reflective TNSS is an evaluation of symptom severity over the past 12 hours prior to the recording of the score. Participants (with assistance from parents/guardians/caregivers, as needed) assessed and recorded four nasal symptoms (runny nose, nasal congestion, nasal itching, and sneezing) twice daily (AM and PM) using the following scale: * 0 = absent (no sign/symptom present) * 1 = mild (sign/symptom clearly present, but minimal awareness; easily tolerated) * 2 = moderate (definite awareness of sign/symptom that is bothersome but tolerable) * 3 = severe (sign/symptom that is hard to tolerate; causes interference with activities of daily living and/or sleeping) The total TNSS scale was 0-12 with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms. Baseline and the during study rTNSS values were defined as the average AM and PM subject-reported rTNSS during each time period.
The serum cortisol weighted mean (0-t), calculated by dividing the area under the concentration-time curve (AUC) from time zero to the time of the last measurable value over the 24-hour period by the sample collection time interval, was determined for each participant at baseline and Week 6, and the ratio of Week 6 over baseline was derived.
| Arm | Type | Description |
|---|---|---|
| BDP Nasal Aerosol 80 mcg/day | EXPERIMENTAL | BDP nasal aerosol: 80 mcg dose once daily in the morning. Participants/parents administer 40 mcg BDP (one spray per nostril) during the 12-week Treatment Period. |
| Placebo Nasal Aerosol | PLACEBO_COMPARATOR | Placebo nasal aerosol: Participants/parents administer placebo (no medication) (one spray per nostril) once daily in the morning during the 12-week Treatment Period. |
| Name | Type | Description |
|---|---|---|
| BDP Nasal Aerosol | DRUG | - |
| Placebo | DRUG | - |
| BDP | DRUG | Beclomethasone dipropionate (BDP) 80 mcg/day (40 mcg/spray, 1 spray/nostril, once daily - total 2 sprays/day) as a nasal aerosol. |
Inclusion Criteria: * Male or female subjects 4 to 11 years of age, inclusive, as of the Screening Visit (SV). * A documented history of PAR to a relevant perennial allergen for a minimum of 12 months (6 months for subjects 4 to 5 years of age) immediately preceding the study Screening Visit (SV). ...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Eli Lilly and Company | LLY | 1 | PHASE3 | LY3650150, Standard therapy for INCS |
| Polyrizon Ltd. | PLRZ | 1 | N/A | Undisclosed |
| Regeneron Pharmaceuticals, Inc. | REGN | 1 | - | Undisclosed |
BDP is an investigational small molecule being developed for the treatment of allergic rhinitis, including perennial allergic rhinitis. It is administered as a nasal aerosol and has been studied in pediatric populations. BDP is currently in Phase 3 clinical development and is not yet approved by regulatory authorities.
BDP is being developed by Teva Pharmaceutical Industries Limited, a company traded on the New York Stock Exchange under the ticker TEVA. Teva is conducting Phase 3 clinical trials to evaluate the safety and efficacy of BDP in patients with allergic rhinitis.
BDP is in Phase 3 clinical development. Two Phase 3 trials have been completed, both focusing on pediatric patients with perennial allergic rhinitis. BDP is an investigational drug and has not received regulatory approval for any indication.
BDP has been studied in two completed Phase 3 clinical trials. NCT01697956 enrolled 99 pediatric subjects with perennial allergic rhinitis, and NCT01783548 enrolled 547 children aged 4 to 11 with the same condition. Both trials were randomized, double-blind, and placebo-controlled, conducted in the United States.
BDP is a small molecule administered as a nasal aerosol for the treatment of allergic rhinitis. It is designed to deliver the active ingredient directly to the nasal passages to address symptoms of allergic rhinitis. The specific molecular target of BDP has not been disclosed in available information.