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
- Powerful Biomarker: It is a powerful, stable biomarker which provides the ability to identify patients at risk and intervene early
- Safe Replacement Approach: Treatment by replacement of an abundant human plasma protein which is depleted is likely to be a benign approach, minimizing safety concerns
BioAegis is planning to conduct its first Severe Community-Acquired Pneumonia (SCAP) phase 2 clinical trial in the EU in 2016. 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.
3 Pillars to Our SCAP Clinical Program
Biomarker-Driven Approach: Plasma Gelsolin Deficiency
Numerous published studies have previously demonstrated that the decline in pGSN levels portends serious morbidity and mortality in both chronic and acute conditions. Thus, measurement of plasma gelsolin levels can predict who will eventually succumb to serious morbidity and mortality. This capability will allow BioAegis to enrich the populations studied in efficacy trials to focus on the patients most likely to benefit from repletion therapy. This will save time and financial resources, while increasing the probability of successful outcomes.
A biomarker-driven approach to solving this challenging medical issue has not been available in past studies of other putative therapeutic agents. Previous studies, as a result, needed to wait until patients’ clinical symptoms were far advanced to organ failure, before intervening with treatment.
pGSN: Powerful Biomarker Drives the Ability to Intervene Early
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: