APATURA: a Phase 2a study of elarekibep, an inhaled IL-4 receptor alpha inhibitor, in moderate-to-severe asthma
Bibliographic record
Abstract
Background: Elarekibep (AZD1402/PRS-060) is an inhaled Anticalin® protein engineered to inhibit IL-4 receptor alpha signaling, a clinically validated asthma target. Methods: A two-part Phase 2a randomized, double-blind, placebo-controlled, dose ranging study in adults ( NCT04643158 ). Part 1 evaluated safety and PK following 28 days twice daily dosing with dry powder formulated elarekibep (1, 3, 10mg) or placebo in controlled patients (ACQ-6 ≤ 1.0) on a stable medium ICS-LABA dose. Part 2 evaluated efficacy of elarekibep (1, 3mg) versus placebo following twice daily dosing for 28 days in a T2-high, uncontrolled moderate-severe asthma population. Results: 72 patients randomized (Part 1: n=50; Part 2: n=22). No clinical safety concerns were reported; the study was stopped early due to new non-clinical findings. Treatment-emergent adverse events were reported for 56.0% (elarekibep, 58.8%; placebo, 50.0%) of patients in Part 1 and 63.6% (elarekibep, 61.5 %; placebo, 66.7%) in Part 2. One SAE, in the 3mg group, was reported during follow up. After inhalation, elarekibep was steadily absorbed (Tmax 3-4 hours) with an elimination half-life ranging between 8-20 hours. Treatment emergent ADAs were detected in 83% (n= 38/46) of elarekibep exposed individuals with no impact on PK characteristics. At Week 4, the LS mean increase (95% CI) in prebronchodilator FEV1 of the 3mg elarekibep group was 196ml (14.3; 378) compared to placebo. Conclusions: Elarekibep was clinically well-tolerated with no identified short-term safety concerns. Due to early study termination, firm conclusions about efficacy could not be drawn. Clinical development has been discontinued due to pre-clinical findings.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.002 | 0.001 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.002 | 0.002 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.002 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.002 | 0.004 |
| Insufficient payload (model declined to judge) | 0.008 | 0.002 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".