Approval Probability
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MTPS9579A · 1 trial · 1 indication
CompEX is defined as time from randomization to first asthma exacerbation or diary worsening during the treatment period. Asthma exacerbation was defined as new or increased asthma symptoms (wheezing, coughing, dyspnea, chest tightness, and/or nighttime awakenings due to these symptoms) that resulted in one or both of the following: Hospitalization or emergency department visit with administration of systemic corticosteroid treatment; Treatment with systemic corticosteroids for at least 3 days, or a long-acting depot corticosteroid preparation with a therapeutic effectiveness of at least 3 days. Diary worsening is based on the occurrence of prespecified changes in the following six parameters: morning peak expiratory flow rate (PEFR), evening PEFR, morning symptom score, evening symptom score, morning short-acting rescue therapy use, and evening short-acting rescue therapy use. Hazard ratio was used for the analysis.
| Arm | Type | Description |
|---|---|---|
| MTPS9579A | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| MTPS9579A | DRUG | MTPS9579A IV infusion will be administered at the randomization visit (Week 2), Week 6, and every 4 weeks through Week 46. |
| Placebo | DRUG | Placebo matching MTPS9579A will be administered at the randomization visit (Week 2), Week 6, and every 4 weeks thereafter through Week 46. |
Inclusion Criteria: * Documented physician-diagnosed asthma for at least 12 months prior to screening * Treatment with asthma controller therapy (daily ICS \[fluticasone propionate or equivalent\] and at least one additional controller therapy \[LABA, LAMA, LTM/LTRA\]) for \>= 3 months prior to scr...
MTPS9579A is an investigational small molecule being developed for the treatment of asthma. It is intended for patients with asthma who require inhaled corticosteroids and a second controller medication. The drug is currently in Phase 2 clinical development and is not yet approved by regulatory authorities.
The specific molecular target of MTPS9579A has not been disclosed. It is a small molecule being studied for its efficacy, safety, and pharmacokinetics in patients with asthma. The mechanism of action is not publicly detailed in available clinical trial information.
MTPS9579A is being developed by Roche Holding AG, a multinational healthcare company. Roche's stock is traded over-the-counter under the ticker symbol RHHBY. The company is conducting clinical trials to evaluate the drug's potential in treating asthma.
MTPS9579A is in Phase 2 clinical development. A Phase 2 trial has been completed, evaluating the drug in patients with asthma. The drug is investigational and has not received FDA approval. Further clinical studies may be needed to establish its safety and efficacy.
MTPS9579A has one completed Phase 2 clinical trial registered under NCT04092582. This randomized, double-blind, placebo-controlled study enrolled 135 participants with asthma across the United States, Argentina, Germany, Peru, and Poland. The trial evaluated the drug's efficacy, safety, and pharmacokinetics in adults aged 18 years and older.