Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Atuliflapon · 1 trial · 1 indication
The clinical efficacy of Atuliflapon Dose A will be assessed by calculating a Hazard Ratio between the treatment arms, Atuliflapon Dose A vs. placebo, in a selected population (based on biomarker level). CompEx Asthma, a novel composite endpoint for exacerbations, captures asthma-worsening episodes based on a combination of diary events (worsening in daily peak expiratory flow (PEF), asthma symptoms and reliever medication use) plus severe asthma exacerbation events.
| Arm | Type | Description |
|---|---|---|
| Lead-in PK cohort (Atuliflapon) | EXPERIMENTAL | Randomised participants will receive Atuliflapon in Lead-in PK period of the study. |
| Lead-in PK cohort (Placebo) | PLACEBO_COMPARATOR | Randomised participants will receive matching placebo to Atuliflapon in Lead-in PK cohort of the study. |
| Part 1 (Atuliflapon) | EXPERIMENTAL | Randomised participants will receive Atuliflapon in Part 1 of the study. |
| Part 1 (Placebo) | PLACEBO_COMPARATOR | Randomised participants will receive matching placebo to Atuliflapon in Part 1 of the study. |
| Name | Type | Description |
|---|---|---|
| Atuliflapon | DRUG | Randomised participants will receive Atuliflapon |
| Placebo | DRUG | Randomised participants will receive matching placebo to Atuliflapon. |
Inclusion Criteria Lead-in PK Cohort: * 18 to 55 years of age inclusive at the time of signing the informed consent at screening Visit 1. * Bodyweight 50 to 120 kg (inclusive) and BMI 18 to 32 kg/m\^2 (inclusive) at screening Visit 1. * Documented asthma diagnosis ≥12 months prior to screening Vis...
Atuliflapon is an investigational small molecule being studied for the treatment of moderate-to-severe uncontrolled asthma. It is being developed by AstraZeneca PLC (ticker: AZN) and is currently in Phase 2 clinical development. The drug has not been approved by regulatory authorities and remains under investigation.
Atuliflapon is a small molecule being developed by AstraZeneca for asthma. The specific molecular target of Atuliflapon has not been disclosed in the available information. The drug is currently in Phase 2 clinical trials for the treatment of moderate-to-severe uncontrolled asthma.
Atuliflapon is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker AZN. The drug is currently in Phase 2 clinical development for the treatment of moderate-to-severe uncontrolled asthma.
Atuliflapon is currently in Phase 2 clinical development. It is an investigational drug being studied for the treatment of moderate-to-severe uncontrolled asthma. The drug has not been approved by regulatory authorities and is not yet available to patients outside of clinical trials.
Atuliflapon has one completed Phase 2 clinical trial registered under NCT05251259, titled "Study to Assess the Efficacy and Safety of Atuliflapon in Moderate-to-Severe Uncontrolled Asthma." The trial enrolled 670 participants across multiple countries including the United States, Japan, Germany, and the United Kingdom.
Atuliflapon is the drug name used in clinical trials for this investigational treatment for asthma. No alternative names have been associated with this drug in the available information. It is being developed by AstraZeneca and is currently in Phase 2 clinical trials.