Biotechnology company Ashvattha Therapeutics’ wholly-owned subsidiary Orpheris has enrolled the first patients in its multicentre Phase II PRANA clinical trial of hydroxyl dendrimer therapeutic (HPT) OP-101.
Under this clinical study, hospitalised adults with severe Covid-19 will be treated.
PRANA is a double-blind, placebo-controlled Phase II clinical trial that evaluates the efficacy of OP-101 in patients with severe Covid-19 as defined by the ordinal score of the World Health Organization (WHO).
The trial will see the enrolment of about 24 patients who will be randomised to receive a single intravenous (IV) infusion of OP-101 (2mg/kg, 4mg/kg or 8mg/kg) or placebo, in addition to the standard of care therapy.
According to Ashvattha, the primary endpoint of the study is safety and tolerability, while the secondary endpoints include efficiency as measured by resolution of fever, improvement in oxygenation, as well as discharge from hospital,
Also included under the secondary endpoints are the number of days free from a ventilator and the number of days in the ICU.
Emory University School of Medicine PRANA study investigator Ishan Mehta said: “Patients with severe Covid-19 can deteriorate rapidly because their immune response to the SARS-CoV-2 virus is exaggerated. This results in hyperinflammation, tissue damage and a cytokine storm, which can lead to lung injury.
“OP-101 is a promising treatment for this patient group due to its ability to selectively target reactive macrophages in the lungs. Patients hospitalised with severe Covid-19 are in desperate need of novel treatments that can accelerate their recovery, reduce length of critical illness and potentially avoid prolonged hospitalisation.”
The study will also analyse the effect of OP-101 in reducing blood levels of pro-inflammatory biomarkers such as C – reactive protein, ferritin as well as interleukin-6 after a single dosage of OP-101.
Initial data from the Phase II proof-of-concept (POC) study is expected to be released in the fourth quarter this year.
Ashvattha Therapeutics CEO and Orpheris executive chairman Jeffrey Cleland said: “With all five clinical trial sites up and running, we are eager to complete enrollment of very sick Covid-19 patients on oxygen and ventilators in our Phase II study.
“As the pandemic continues to spread in the United States and globally, novel approaches that can reduce the devastating effect of hyperinflammation in critically ill hospitalised patients are urgently needed.”