Kamada has reported top-line results from its Phase I/II clinical trial of anti-SARS-CoV-2 plasma-derived hyperimmune globulin (IgG) for treating hospitalised Covid-19 patients in Israel.
Conducted as part of the company’s global partnership with Kedrion Biopharma, the trial evaluated the safety, anti-SARS-CoV-2 IgG levels, virus neutralisation activity and other exploratory efficacy outcomes in hospitalised, non-ventilated Covid-19 patients with pneumonia.
The open-label, single-arm, multi-centre trial enrolled 12 eligible subjected aged 34-69. They received 4g dose of Kamada’s product within three to ten days of symptom onset.
The participants were followed up for 84 days after the treatment.
In September last year, Kamada had reported interim data results from the study.
Results showed that 11 out of the 12 subjects recovered on receiving the treatment while seven were discharged from the hospital at or before day five post-treatment. The remaining four subjects were discharged by day nine.
In addition, anti-SARS CoV-2 IgG levels in the plasma of all patients improved on administering the product.
The IgG product showed a favourable safety profile and no infusion-related reactions or adverse events related to the study drug were observed.
In January this year, the Israeli Ministry of Health commenced a multi-centre clinical study of Kamada’s Covid-19 IgG product.
Currently, the trial has enrolled over 100 hospitalised patients with moderate to severe Covid-19. They randomly received either 4g IgG product or two units of convalescent plasma and will be followed up for 14 days.
Kamada CEO Amir London said: “We believe the top-line results of our Phase I/II study are indicative of the potential of our plasma-derived IgG product to be a safe and effective treatment for hospitalised Covid-19 patients.
“Along with our partner, Kedrion Biopharma, we will evaluate the results of the ongoing multicentre clinical study being conducted by the IMOH, which are expected later in 2021, in order to determine the next steps with respect to our Covid-19 IgG clinical development programme.”