BioAegis Therapeutics, a private clinical-stage company based in North Brunswick, N.J., has announced a collaboration with Prenosis to apply AI-driven analytics to its Phase II trial of rhu-pGSN in acute respiratory distress syndrome.
BioAegis’ ongoing Phase II clinical trial of recombinant human plasma gelsolin (rhu-pGSN) in moderate-to-severe acute respiratory distress syndrome. Under the arrangement, Prenosis will analyze biospecimens and clinical data from BTI-203, BioAegis’ randomized, double-blind, placebo-controlled study enrolling 600 patients across sites in the United States, Canada, and Europe, with the goal of identifying biological signatures and patient subpopulations most likely to respond to rhu-pGSN therapy. No financial terms were disclosed.
rhu-pGSN is an immunomodulatory biologic designed to replenish plasma gelsolin, an endogenous actin-scavenging protein that becomes depleted in critically ill patients. Extracellular actin released from damaged cells is pro-inflammatory and cytotoxic; rhu-pGSN severs and caps actin filaments, reducing downstream inflammatory signaling. The compound is being evaluated as adjunctive therapy alongside standard supportive care in patients with a P/F ratio at or below 150, a threshold defining moderate-to-severe disease. BioAegis holds an exclusive worldwide license to intellectual property covering rhu-pGSN through Harvard University and Brigham and Women’s Hospital, comprising more than 40 issued patents spanning inflammatory disease, infection, renal failure, neurologic disease, and frailty.
Prenosis will apply its Immunix platform to the BTI-203 dataset. Immunix integrates proteomic, transcriptomic, and clinical variables through machine learning to identify immune phenotype clusters and predictive biomarker signatures in complex disease states. The platform’s prior regulatory history includes FDA De Novo authorization for Sepsis ImmunoScore, an AI-based diagnostic tool for sepsis, and Prenosis holds a USD 20 million contract from the Biomedical Advanced Research and Development Authority to support further development of AI-enabled companion diagnostics in critical illness. That government award is independent of the BioAegis arrangement.
The collaboration is structured as a research-stage partnership. BioAegis retains ownership of rhu-pGSN and provides access to biospecimens and trial data; Prenosis contributes analytical infrastructure. No development milestones, royalty terms, territorial rights, or equity components were described in the announcement. BTI-203 is registered as NCT05947955 and is currently recruiting.
ARDS has no FDA-approved pharmacological treatment, and the field has attributed many prior trial failures in part to biological heterogeneity within enrolled populations. rhu-pGSN’s mechanism — restoring a depleted host-defense protein rather than suppressing a single cytokine — produces effects that may vary across immune states, making patient stratification a relevant variable for interpreting Phase II results. Prenosis’ platform was purpose-built to resolve immune-state-dependent treatment effects of this kind, and its prior application in sepsis, a condition that shares pathophysiological features with ARDS, provides a degree of mechanistic alignment with the current program. BioAegis has also received federal funding for BTI-203 under a separate BARDA contract (number 75A50123C00067). No prior relationship between BioAegis and Prenosis was referenced in the announcement.