Israeli plasma-derived biopharmaceutical company Kamada Ltd. (Nasdaq: KMDA; TASE: KMDA) today announced that the first patient has been enrolled in Israel in a Phase 1/2 clinical trial of its anti-SARS-CoV-2 plasma-derived antibody product as a potential treatment for Covid-19.
The Phase 1/2 multi-center study was approved by the Ministry of Health in Israel. The trial will assess the safety, pharmacokinetics, and pharmacodynamics of Kamada's plasma-derived antibody treatment in hospitalized, non-ventilated Covid-19 patients with pneumonia. Twelve 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 Kamada also plans to further explore the potential of its antibody treatment to prevent COVID-19 disease in healthy subjects at risk in a separate study.
Kamada says that its plasma-derived antibody treatment has been evaluated for SARS-CoV-2 neutralization activity and that preliminary results are encouraging.
Kamada CEO Amir London said, "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. 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."
This trial is part of the global collaboration agreement established in April 2020 between Kamada and Kedrion Biopharma for the development, manufacturing and distribution of a plasma-derived immunoglobulin (IgG) product as a potential treatment for Covid-19.
To expand its COVID-19 clinical development program to the US, Kamada and Kedrion will conduct a pre-Investigational New Drug (IND) meeting with the US Food and Drug Administration (FDA) during the current quarter in order to obtain FDA’s acceptance of the proposed clinical development program. If FDA clearance of the IND is granted, Kamada and Kedrion intend to initiate their clinical program in the US in early 2021.
Published by Globes, Israel business news - en.globes.co.il - on August 10, 2020 © Copyright of Globes Publisher Itonut (1983) Ltd. 2020