Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ARS-1 · 2 trials · 2 indications
Difference in forced expiratory volume in 1 second (FEV1) based on area under the curve (AUC)
Assess time to effect and duration of effect on acute flares associated with urticaria based on a patient reported pruritus/hive score, from 0 (none) to 3 (severe) for itch and hive using Uniform Assessment System (UAS) as below: Severity Score Amount of Itch Itch Severity 0 None None 1. Mild Easily tolerated 2. Moderate Bothersome but tolerable 3. Intense Difficult to tolerate Hive Severity Score Number of Hives 0 None 1. 1-6 2. 7-12 3. \>12
| Arm | Type | Description |
|---|---|---|
| Sequence 1 | ACTIVE_COMPARATOR | ARS 2mg: albuterol: Placebo: ARS 1mg |
| Sequence 2 | ACTIVE_COMPARATOR | ARS 1mg: Placebo: albuterol: ARS 2mg |
| Name | Type | Description |
|---|---|---|
| ARS-1 1 mg | DRUG | ARS-1 1 mg |
| Albuterol MDI | DRUG | 180 mcg |
| Placebo | DRUG | Placebo |
| ARS-1 2mg | DRUG | ARS-1 2mg |
| ARS-1 | DRUG | A single treatment of ARS-1 1mg, 2 mg or placebo |
Inclusion Criteria: * 1\. Is a male or female subject between the ages of 12 and 65 years, inclusive. * 2\. Asthma that has been stable for at least four weeks prior to screening as defined by clinical history. * 3\. Reversible bronchoconstriction. * 4\. Has body weight more than 30 kilogram (kg) a...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Novartis AG Sponsored ADR | NVS | 10 | PHASE3 | LOU064 |
| Celldex Therapeutics, Inc. | CLDX | 4 | PHASE3 | barzolvolimab |
| Pfizer Inc. | PFE | 1 | PHASE2 | Ritlecitinib |
| ARS Pharmaceuticals, Inc. | SPRY | 1 | PHASE2 | epinephrine |
| Jasper Therapeutics, Inc. | JSPR | 2 | PHASE2 | Briquilimab |
| Blueprint Medicines Corporation | BPMC | 1 | PHASE2 | BLU-808 |
| Azitra Inc | AZTR | 1 | PHASE1 | ATR04-484, Vehicle |
| BeOne Medicines Ltd. Sponsored ADR | ONC | 1 | PHASE1 | BGB-16673 |
| Enanta Pharmaceuticals, Inc. | ENTA | 1 | PHASE1 | EDP-978 |
ARS-1 is an investigational small molecule being studied for the treatment of asthma, urticaria, and upper respiratory tract infection. It is developed by ARS Pharmaceuticals, Inc. (NASDAQ: SPRY) and is currently in Phase 2 clinical development for these respiratory and allergic conditions.
The specific molecular target of ARS-1 has not been disclosed. The drug is being studied for its effects in conditions such as asthma, urticaria, and upper respiratory tract infection, but its mechanism of action has not been publicly detailed.
ARS-1 is being developed by ARS Pharmaceuticals, Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol SPRY. The company is conducting clinical trials to evaluate the drug's safety and efficacy in respiratory and allergic conditions.
ARS-1 is in Phase 2 clinical development. It has completed three clinical trials, including one Phase 1 study and two Phase 2 studies, with a total enrollment of 21 participants across the trials. The drug is not yet approved and remains investigational.
ARS-1 has been studied in three completed trials: NCT04930900, a Phase 1 pharmacokinetic study in subjects with upper respiratory tract infection; NCT05363670, a Phase 2 study of ARS-1 or albuterol in subjects with persistent asthma; and NCT05496465, a Phase 2 safety and efficacy study in subjects with frequent urticaria flares.
ARS-1 is not the same as epinephrine, but it is being studied as an intranasal formulation of epinephrine. Clinical trials have evaluated the safety and efficacy of intranasal epinephrine after administration of ARS-1 in subjects with frequent urticaria flares, indicating the drug contains epinephrine as its active ingredient.