TISA-818, an Anti-inflammatory Conjugate of Montelukast-Decapeptide, in Acute Respiratory Distress Syndrome Due to Pulmonary Infection: A Phase 2 Randomized Trial Using the 2023 Global Definition

Huang, L; Huang, X; Jiao, F; Sun, B; Han, X; Jiang, W; Zhang, W; Luo, H; Su, L; Gu, M; He, J; Jiao, L; Tang, X; Jiang, L; Wang, D; Yang, M; Yang, X; Li, D; Wang, H; Yuan, X; Lin, H; Shao, Z; Lu, K; Yan, B; Zhang, Y; Liu, K; Kärnell, A; Zhan, Q

doi:10.1016/j.chest.2026.09.095

Respiratory failure & ventilation

TISA-818, an Anti-inflammatory Conjugate of Montelukast-Decapeptide, in Acute Respiratory Distress Syndrome Due to Pulmonary Infection: A Phase 2 Randomized Trial Using the 2023 Global Definition

ChestPublished 3 Oct 2026randomized, double-blind, placebo-controlled, multicenter phase 2 trial

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Authors' conclusion

TISA-818 was generally well tolerated. Day-28 mortality was numerically imbalanced but not sustained, likely reflecting small-sample variability; cautious interpretation is warranted. Consistent improvements across all efficacy endpoints, particularly with 6 mg BID in non-intubated patients, support further investigation in adequately powered trials.

Study context

Population: Patients with acute respiratory distress syndrome (ARDS) due to pulmonary infection, including non-intubated patients, defined by the 2023 global ARDS definition, in Chinapatients randomized · prespecified non-intubated subgroup 27
Participants: Fifty-eight patients

Comparison: Intravenous TISA-818 6 mg twice daily (BID), 12 mg once daily (QD), or matched placebo
Primary endpoint: Safety

Methodological details2023 global ARDS definition

2023 global ARDS definition

Primary result

As reported in the abstract

Placebo5.3%

6 mg BID36.8%

12 mg QD21.1%

Secondary outcomes

Mortality · Day 28

6 mg BID10.5%

12 mg QD26.3%

Placebo5.3%

Mortality · Day 60

6 mg BID21.1%

12 mg QD31.6%

Placebo26.3%

Outcome		Difference (days) (95% CI)
Respiratory support-free days (RSFDs) through day 28, prespecified non-intubated subgroup (n=27, 9 per arm)6 mg BID vs placebo · more RSFDs with 6 mg BID · exploratory analyses · prespecified subgroup	−1001020	6 (−3 to 15)
	−1001020Difference, days (linear scale)

Respiratory support-free days (RSFDs) through day 28, prespecified non-intubated subgroup (n=27, 9 per arm)

Consistent numerical improvements across all secondary outcomes with 6 mg BID vs placebo

Reference

Authors: Huang L, Huang X, Jiao F, Sun B, Han X, Jiang W, et al.
All 28 authors
Huang L, Huang X, Jiao F, Sun B, Han X, Jiang W, Zhang W, Luo H, Su L, Gu M, He J, Jiao L, Tang X, Jiang L, Wang D, Yang M, Yang X, Li D, Wang H, Yuan X, Lin H, Shao Z, Lu K, Yan B, Zhang Y, Liu K, Kärnell A, Zhan Q
Journal: Chest
Published: 3 Oct 2026
DOI: 10.1016/j.chest.2026.09.095
PubMed: 42829168

Topic: Respiratory failure & ventilation
Also indexed: Sepsis & infection

Intervention details

6 mg BID: intravenous TISA-818 6 mg twice daily (BID) for 14 days
12 mg QD: intravenous TISA-818 12 mg once daily (QD) for 14 days
placebo: matched placebo for 14 days

Key notes

Comparable rates of treatment-emergent adverse events (AEs) and no unexpected safety signals
Treatment-related AEs were mild-to-moderate

More notes

No drug-related serious AEs or deaths occurred

Original publication

TISA-818, an Anti-inflammatory Conjugate of Montelukast-Decapeptide, in Acute Respiratory Distress Syndrome Due to Pulmonary Infection: A Phase 2 Randomized Trial Using the 2023 Global Definition. Chest. Published 3 October 2026. doi:10.1016/j.chest.2026.09.095

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