The purpose of this Ph2b study is to characterize the dose-response relationship and to evaluate the safety and efficacy of three different single doses of TIN816 in hospitalized adult participants in an intensive care setting with a diagnosis of sepsis-associated acute kidney injury (SA-AKI).
Phase 2 trials begin testing efficacy in a larger patient group (100–300). This is often where biotech binary events occur — positive Phase 2 data can significantly advance a company's pipeline narrative, while failures can be terminal for a program.
This trial has completed. Results may be available via ClinicalTrials.gov or peer-reviewed publications.
Novartis AG (NVS) is the sponsoring company for this trial. BiotechSign currently grades this company C (51/100) based on composite catalyst signals across its full pipeline. This trial is one data point in that overall catalyst picture.