Yet another milestone in the global Kedrion-Kamada collaboration for the development, manufacturing and distribution of a plasma-derived immunoglobulin (IgG) product as a potential treatment for coronavirus disease (COVID-19).
On Aug. 10, 2020 Kamada Ltd. 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.
In order to expand its COVID-19 clinical development program to the U.S., Kamada, with the support of Kedrion, intends to conduct a pre-Investigational New Drug (IND) meeting with the U.S. Food and Drug Administration (FDA) during the current quarter in order to obtain FDA’s acceptance of the proposed clinical development program. Pursuant to the collaboration between the two companies, Kedrion is responsible for the collection of COVID-19 convalescent plasma from U.S. recovered patients. Kedrion is collecting the plasma through its plasma business unit, KEDPLASMA, at 23 FDA-approved centers across the United States. If FDA clearance of the IND is received, Kamada and Kedrion intend to initiate their clinical program in the U.S. in early 2021.