Kamada Announces Enrollment of First Patient in its Phase 1/2 Clinical Trial of its Plasma-Derived Immunoglobulin (IgG) Product as a Potential Treatment for Coronavirus Disease (COVID-19) in Israel

• Study Participants are Hospitalized, Non-ventilated COVID-19 Patients with Pneumonia 
  
• Encouraging Neutralization Activity Observed with Virus Neutralization Assay
• Pre-IND Meeting with U.S. FDA to be Conducted in Current Quarter, with U.S. Clinical Development Expected to Commence in Early 2021
• Kamada Intends to Further Explore its IgG Product as a Potential Preventive Therapy for COVID-19 Disease in Healthy Subjects at Risk in a Separate Clinical Study

REHOVOT, Israel, Aug. 10, 2020 (GLOBE NEWSWIRE) -- Kamada Ltd. (NASDAQ & TASE: KMDA), a plasma-derived biopharmaceutical company, today announced that the first patient has been recruited to the Phase 1/2 clinical trial of its anti-SARS-CoV-2 plasma-derived immunoglobulin (IgG) product as a potential treatment for coronavirus disease (COVID-19) in Israel.

This Phase 1/2 open-label, single-arm multi-center study was approved by the Ministry of Health in Israel.  The trial will assess the safety, pharmacokinetics, and pharmacodynamics of the Company’s plasma-derived IgG product in hospitalized, non-ventilated COVID-19 patients with pneumonia. A total of 12 eligible patients will be enrolled and receive Kamada’s product at a single dose of 4g within 10 days of initial symptoms. Patients will be followed for 84 days. In parallel, Kamada intends to further explore the potential of its IgG product to prevent COVID-19 disease in healthy subjects at risk in a separate study.

Kamada’s plasma-derived IgG product has been evaluated for SARS-CoV-2 neutralization activity. Preliminary results are encouraging and suggest potential high neutralization titer.

“Following our announcement in June regarding the availability of our COVID-19 IgG product for compassionate use treatment in Israel, we are happy to report further advancement of our program with the initiation of this important clinical trial,” said Amir London, Kamada’s Chief Executive Officer. “We are encouraged by the results of the product neutralization activity and we believe our product has the potential to be an effective treatment for hospitalized, non-ventilated COVID-19 patients with pneumonia, and look forward to the results from this trial.”