Candidate: rhu-pGSN
Type: Recombinant human plasma gelsolin therapy based on intellectual property licensed from Harvard Medical School
Status: BioAegis said July 15 it received regulatory clearance from The Spanish Agency for Medicines and Health Products (AEMPS) for its Phase II trial (NCT04358406) designed to assess rhu-pGSN in hospitalized patients with severe COVID-19 pneumonia. The randomized, double-blind, placebo-controlled, proof-of-concept trial is designed to enroll 60 participants and evaluate the safety and effectiveness of rhu-pGSN added to standard of care.
Primary outcome measures include the proportion of subjects alive not on vasopressors, mechanical ventilator, and dialysis at Day 14; and the proportion of subjects with serious adverse events through Day 28.
In May, BioAegis said the NIH Clinical Center is measuring patient gelsolin levels as part of the NIAID Strategic Plan for COVID-19 Research. John Gallin, MD, Chief of Clinical Pathophysiology Section of the Laboratory of Clinical Immunology and Microbiology (LCIM), is leading the study, part of a larger international collaborative to understand the immune response during COVID-19 infection and convalescence.
BioAegis reasons that supplementing gelsolin with rhu-pGSN holds potential to prevent the morbidity and mortality seen in COVID-19, citing in part a completed Phase Ib/IIa study in hospitalized community-acquired pneumonia patients that showed no adverse safety signals. The company has published a white paper outlining how rhu-pGSN supplementation would work in COVID-19.
In April, BioAegis said it is submitting requests to the FDA and other regulators seeking to accelerate clinical trials of its lead product rhu-pGSN in severe infection, specifically severe community-acquired pneumonia (sCAP), including COVID-19, and has engaged “leading” infectious disease experts to advise the proof of concept clinical trial strategy. The company reasons that administering rhu-pGSN as an adjunct to standard-of-care measures could prevent or limit organ injury and death in patients with severe coronavirus infections.
BioAegis said plasma gelsolin has been tested in over 20 animal studies, as well as a recent phase Ib/IIa study in hospitalized community-acquired pneumonia patients with no adverse safety signals.
COVID-19: 200 Candidates and Counting
To navigate through the >200 potential therapeutic and vaccine options for COVID-19, GEN has grouped the candidates into four broad categories based on their developmental and (where applicable) clinical progress:
● FRONT RUNNER – the most promising therapeutics/vaccines based on clinical progress, favorable data or both.
● DEFINITELY MAYBE – earlier phases with promising partners, or more advanced candidates in development that have generated uneven data
● KEEPING AN EYE ON… – interesting technology, attracting notable partners, or both, but preliminary data.
● TOO SOON TO TELL – longshots pending additional experimental and/or clinical data.
GEN has also tagged the most common treatment types:
● ANTIVIRAL
● VAX
● ANTIBODY
● RNA
