CARPO Phase 2b data support continued development of Auxora in acute pancreatitis.
In CARPO, no new-onset severe respiratory failure was observed in the medium- and high-dose Auxora groups, versus 8.5% with placebo. CalciMedica is aligned with FDA on the design of a planned Phase 2b study using this outcome as the primary endpoint.
A high-burden acute disease with no approved drug therapy.
Acute pancreatitis accounted for approximately 255,000 U.S. hospital admissions in 2021. Current treatment is supportive. Severe disease can progress to respiratory failure, multi-organ failure, pancreatic necrosis, and prolonged hospitalization.
Source: 2021 National Inpatient Sample, reported in Peery et al., Gastroenterology (2025) (opens in a new tab).
Prevented new-onset severe respiratory failure at the medium and high Auxora doses.
Among patients without respiratory failure at baseline, new-onset severe respiratory failure occurred in 8.5% of patients receiving placebo and 0% of patients receiving either medium- or high-dose Auxora.
Observed reduction in new-onset severe respiratory failure
0% at medium and high doses versus 8.5% with placebo; p<0.05 for each comparison
Observed reduction in severe organ failure
3.6% and 3.8% at the medium and high doses versus 9.4% with placebo.
Hierarchical win ratio
Favored high-dose Auxora across key clinical outcomes; 95% CI 1.03–2.61; p=0.037
A randomized, dose-ranging Phase 2b study in 216 patients.
CARPO enrolled patients with acute pancreatitis and systemic inflammatory response syndrome and randomized them 1:1:1:1 to three Auxora dose groups or matching placebo.
Endpoints
- Time to solid-food tolerance (primary endpoint)
- Severe organ failure
- Respiratory failure
- Length of hospital stay
- Time to medically indicated discharge
- Necrosis
No new-onset severe respiratory failure at the medium and high doses.
New-onset severe respiratory failure is the FDA-aligned primary endpoint for the planned next Phase 2b study.
New-onset severe respiratory failure
Event rate by arm
100% observed reduction at the medium and high doses; p<0.05 for each comparison. Modified intent-to-treat population excluding patients with respiratory failure at baseline, n=197.
Severe organ failure
Event rate by arm
Approximately 60% observed reduction at the medium and high doses. Modified intent-to-treat population, N=214. Severe organ failure includes severe respiratory, renal, and cardiovascular failure.
Exploratory win-ratio analysis favored high-dose Auxora across key outcomes.
Win ratio 1.64 · 95% CI 1.03–2.61 · p = 0.037| Endpoint | Placebo wins | Auxora 2.0 mg/kg wins |
|---|---|---|
| All-cause mortality | — | — |
| New-onset severe respiratory failure | 0.0% | 7.5% |
| New-onset necrotizing pancreatitis | 13.6% | 22.3% |
| Time to medically indicated discharge | 19.8% | 26.5% |
| All pairwise comparisons | 33.4% | 56.3% |
Each pair compares an Auxora patient with a placebo patient. A win means a better outcome, assessed in the order shown. Ties are not shown.
Using LDH to identify patients at higher risk.
In a retrospective CARPO analysis, placebo-treated patients with elevated lactate dehydrogenase (LDH) had a higher rate of new-onset severe respiratory failure. The planned Phase 2b trial will evaluate LDH to identify patients at higher risk.
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New-onset severe respiratory failure occurred in 20.0% of placebo patients with LDH >240 U/L, compared with 8.5% of the overall placebo group.
CARPO exploratory analysis
6 of 8 cases
Six of eight patients who developed new-onset severe respiratory failure had baseline LDH above 240 U/L. One had LDH of 238 U/L; one had no LDH measurement available.
Higher LDH also tracked with greater inflammation: median IL-6 was 134 versus 49 pg/mL in the higher- and lower-LDH groups, respectively (p=0.004).
Retrospective analysis excluding patients with respiratory failure at baseline.
Independent retrospective study
A similar LDH threshold in a separate patient population.
In a study of 111 ICU patients with hypertriglyceridemic acute pancreatitis, LDH was associated with acute respiratory distress syndrome (ARDS), which developed in 61 patients.
- LDH cutoff
- 249.5 U/L
- Area under the ROC curve
- 0.868
The cutoff was close to the >240 U/L threshold identified in CARPO, lending support to prospective evaluation of LDH enrichment.
Zhu et al., Emergency Medicine International (2026) (opens in a new tab)A Phase 2b trial focused on patients at higher risk.
Following a Type C meeting, CalciMedica aligned with FDA on the planned Phase 2b trial design.
Primary endpoint
New-onset severe respiratory failure.
Key secondary endpoints
- Multi-organ failure
- Time to medically indicated discharge
Enrichment strategy
Evaluate elevated LDH as a marker of severe respiratory-failure risk.
Development objective
Evaluate LDH enrichment and inform the design of a potential registrational trial.