SCAP Clinical Program

The Advantages of Plasma Gelsolin to Combat SCAP

One of the difficulties in treating CAP is that the determination of the instigating pathogen is often elusive. pGSN is pathogen-agnostic and can mobilize the innate immune response to address both viral and bacterial (gram + and gram -) CAP, thus offering a powerful solution. At the same time, it can prevent incremental organ damage giving patients a longer runway to mount a secondary adaptive immune response. With less subsequent damage, patients should recover faster and require less hospitalization.

This advantage to the patient is driven by:

  • Multiple Functions: Plasma gelsolin improves the body’s defense against the instigating pathogen while preventing the spread of uncontrolled inflammation
  • Extensive Data: Effectiveness in multiple animal models of inflammatory and infectious disease, as well as evidence of depletion associated with risk of poor outcomes in those corresponding diseases.
  • Safe Supplementation Approach: Treatment by supplementation of an abundant human plasma protein which is depleted is likely to be a benign approach, minimizing safety concerns

Development Status

BioAegis is currently initiating its first Community-Acquired Pneumonia (CAP) phase 2 clinical trial. A previous phase 1b/2a pharmacokinetic studies of plasma gelsolin was successfully conducted in critical care patients.

Severe CAP is a Launchpad to Other Indications

While the initial planned indication is severe community-acquired pneumonia, BioAegis intends to subsequently pursue other acute and chronic inflammatory and infectious conditions.

Minimizing Clinical Trial Risk: Prospective Pneumonia Study Data

Bioaegis is currently working to both improve trial efficiency and ensure its success by refining its clinical trial design with data on plasma gelsolin levels obtained from a large prospective pneumonia study being conducted in collaboration with Vanderbilt and Northwestern University.

A recent New England Journal of Medicine publication reported the findings of this study: Community-Acquired Pneumonia Requiring Hospitalization Among US Adults, S. Jain, W.H. Self, R.G. Wunderink, S. Fakhran, R. Balk, A.M. Bramley, C. Reed, C.G. Grijalva, E.J. Anderson, D.M. Courtney, J.D. Chappell, C. Qi, E.M. Hart, F. Carroll, C. Trabue, H.K. Donnelly, D.J. Williams, Y. Zhu, S.R. Arnold, K. Ampofo, G.W. Waterer, M. Levine, S. Lindstrom, J.M. Winchell, J.M. Katz, D. Erdman, E. Schneider, L.A. Hicks, J.A. McCullers, A.T. Pavia, K.M. Edwards, and L. Finelli, for the CDC EPIC Study Team

Phase 2 Proof of Concept Study in SCAP Patients

Plasma gelsolin will be studied clinically in upcoming Phase 2 studies with the objective to reduce: