BioAegis (North Brunswick, NJ) is evaluating data from a Phase 2 clinical trial related to recombinant human plasma gelsolin (rhu-pGSN) along with standard of care in treating patients with severe COVID-19 pneumonia.
In the interim, the company has announced the results of a compassionate use case study involving a hospitalized patient with critical COVID-19 pneumonia. The study was published in Clinical Infection in Practice.
“While a single case study does not prove efficacy of our treatment, it was gratifying to observe a rapid and complete recovery of a patient with critical COVID pneumonia,” said study co-author and BioAegis’ chief medical officer, Dr. Mark DiNubile, in a statement. “The maximum benefit of immunotherapies, like gelsolin, appears to be in the sickest patients where there is an overexuberant inflammatory response.”
Gelsolin is a naturally occurring actin-binding protein that can become depleted in people infected with SARS-CoV-2.
The study involved a 73-year-old generally healthy woman who required intubation and sedation upon the fifth day of hospitalization for COVID-19 pneumonia. Her blood pressure dropped to a level necessitating pressor drugs for 36 hours, at which point clinicians administered three doses of rhu-pGSN. Ultimately, the patient’s blood pressure stabilized without the need for antihypotensive vasopressors. The patient also received antibiotics.
Five days after the rhu-pGSN therapy, the patient was extubated and stopped antibiotic treatment.
On the fifth day after gelsolin treatment, she was extubated, and antibiotics were discontinued.
The company finished recruitment for its Phase 2 COVID-19 study in March.
Earlier this year, BioAegis won a contract from Biomedical Advanced Research and Development Authority (BARDA), a division of HHS related to the development of a therapy for severe sepsis.
The company is also pursuing treatments for idiopathic bronchiectasis, neuroinflammation, arthritis and lupus nephritis.
Filed Under: clinical trials, Drug Discovery, Infectious Disease