Kamada Reports Top-line Data Of Plasma-Derived IgG Treatment From Early-Stage COVID-19 Trial

Kamada Ltd KMDA has announced top-line results from its Phase 1/2 trial in Israel evaluating plasma-derived hyperimmune globulin (IgG) treatment for COVID-19.

• Kamada had announced the interim results from the study in September last year.
• A total of 12 eligible patients were enrolled and received a single dose of 4 grams within three to 10 days of initial symptoms. The patients were followed for 84 days post-treatment.
• As previously reported, 11 of the 12 patients recovered following the treatment. Seven patients were discharged from the hospital at or before day five post-treatment, and the remaining four patients were discharged by day 9.
• Following the infusion of the product, anti-SARS CoV-2 IgG levels in the plasma of all patients increased.
• The effect of the treatment on neutralization activity is further analyzed. However, interim data demonstrated that the IgG level increase was associated with enhanced neutralization activity.
• The treatment showed a favorable safety profile, and there were no infusion-related reactions or adverse events.
• Two serious adverse events in the study were reported. Both were considered not related to the study drug.
• One patient died on day 37 post-treatment due to complications from COVID-19.
• One patient was diagnosed post-discharge with pulmonary embolism on day 7 of the study. The patient was re-hospitalized, treated with anticoagulation therapy, recovered within two days.
• The initial order from the Israeli Ministry of Health for the product is sufficient to treat approximately 500 hospitalized patients and is expected to generate roughly $3.4 million in revenue for Kamada.
• Israeli Ministry of Health is conducting a clinical study comparing Kamada's product to convalescent plasma in hospitalized patients.
• Though earlier this month, the National Institutes of Health halted a trial evaluating the safety and effectiveness of COVID-19 convalescent plasma as it found no benefit.
• Price Action: KMDA shares are trading 1.82% higher at $6.14 in premarket trading on the last check Wednesday.