TISA-818

TISA-818 (Montelukast–Decapeptide Conjugate)

Evidence & Status

  • Moderate Evidence
  • Moderate

At a Glance

A peptide-containing conjugate studied in a small safety-focused ARDS trial with exploratory efficacy findings and numerical mortality imbalances.

Plain English

TISA-818 was tested in people with ARDS associated with pulmonary infection. The study was too small to establish treatment benefit. Death rates differed numerically between groups, so it should not be described as safe, effective or mortality-reducing.

Overview

TISA-818 is a montelukast–decapeptide anti-inflammatory conjugate, not montelukast alone. A small Phase 2 randomized trial studied pulmonary-infection-associated acute respiratory distress syndrome (ARDS). Its primary endpoint was safety, efficacy analyses were exploratory, and mortality was numerically imbalanced between groups. This is disease-specific research, not evidence of general immune support or an established ARDS treatment.

Research Summary

The multicentre, double-blind, placebo-controlled Phase 2 trial randomized 58 participants to 14 days of intravenous TISA-818 or placebo. In placebo, twice-daily and once-daily groups respectively, treatment-related adverse-event rates were 5.3%, 36.8% and 21.1%; Day-28 mortality was 5.3%, 10.5% and 26.3%; Day-60 mortality was 26.3%, 21.1% and 31.6%. Investigators reported no drug-related serious adverse events or deaths, but that attribution does not erase the numerical mortality imbalance or establish safety. In the prespecified non-intubated subgroup of 27 participants, the exploratory respiratory-support-free-days difference for twice-daily treatment versus placebo was 6 days (95% CI −3 to 15). The interval includes no benefit; these exploratory findings do not establish efficacy. Further adequately powered investigation is needed.

Research Areas

  • Pulmonary-infection-associated ARDS
  • Disease-specific inflammation research

Safety & Risks

Serious Risks

  • Mortality was numerically imbalanced in the small ARDS trial. Drug causality was not established, and investigators' attribution does not remove this safety uncertainty.

Reported Side Effects

  • Treatment-related adverse events were reported as mild to moderate; rates differed between regimens
United States
Investigational research; no approved clinical use is asserted by this record.
United Kingdom
Current authorization status not established in this record.
Australia
Current authorization status not established in this record.
Canada
Current authorization status not established in this record.

Citations & Sources