We wrote about Kamada in March when the company announced its plans to utilise its Hyper-Immunoglobulin (IgG) Platform Technology to develop an anti-corona (COVID-19) immunoglobulin as a potential therapy for severely ill coronavirus patients.
Kamada is a commercial-stage plasma-derived biopharmaceutical company with an existing marketed product portfolio and a late-stage product pipeline. The company uses its proprietary platform technology and know-how for the extraction and purification of proteins from human plasma to produce Alpha-1 Antitrypsin (AAT) in a highly purified, liquid form, as well as other plasma-derived immunoglobulins.
In August the company received a strong validation of its proprietary technology with news of progress in the efforts to develop coronavirus treatments and vaccines. The U.S government and the FDA issued emergency use authorization for convalescent plasma as a treatment for COVID-19 in hospitalized patients. Notably, convalescent plasma is the liquid component of the blood-containing antibodies from patients who have recovered from the virus. Kamada is arguably the leader in the COVID-19 plasma-based therapy space.
At the beginning of September (as we write this report) the company announced the completion of enrolment and initial interim results from its phase 1/2 clinical trial in Israel of its plasma-derived hyperimmune immunoglobulin (IgG) product as a potential treatment for coronavirus disease (COVID-19). The results were:
- symptoms improvement observed in 11 of the 12 patients within 24 to 48 hours of treatment;
- all 11 patients subsequently discharged from hospital within a median of 4.5 days from treatment
- IgG product demonstrated favourable safety profile to date
- top-line results expected to be available by January of 2021
- U.S. FDA response on submitted pre-IND information package expected next month
- U.S. clinical development anticipated to commence in Early 2021
The phase 1/2 trial in Israel is being conducted as part of Kamada’s global collaboration with Kedrion Biopharma (a U.S based Biopharma company) for the development, manufacturing, and distribution of a plasma-derived IgG product as a potential treatment for COVID-19. With Kedrion’s support, Kamada has submitted a pre-Investigational New Drug (IND) information package to the U.S. FDA, with its proposed U.S clinical development plan. The FDA’s response is expected next month.
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