Kamada Ltd. (KMDA) Reports Top-line Results from Phase 1/2 Clinical Trial of Plasma-Derived Hyperimmune Globulin Treatment for COVID-19

March 31, 2021 6:10 AM EDT
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Kamada Ltd. (NASDAQ: KMDA), a plasma-derived biopharmaceutical company, today announced top-line results from its Phase 1/2 open-label, single-arm, multi-center clinical trial in Israel of the Company’s anti-SARS-CoV-2 plasma-derived hyperimmune globulin (IgG) treatment for coronavirus disease (COVID-19). Interim results from this study were announced by Kamada in September 2020.

The trial, conducted as part of Kamada's global collaboration with Kedrion Biopharma, assessed the safety, anti-SARS-CoV-2 IgG levels, virus neutralization activity and other exploratory efficacy outcomes in hospitalized, non-ventilated COVID-19 patients with pneumonia. A total of 12 eligible patients (age 34-69) were enrolled in the study and received the Company’s product at a single dose of 4 grams within three to 10 days of initial symptoms. Patient were followed for 84 days post treatment.

As previously reported, 11 of the 12 patients recovered following receipt of the treatment. Seven patients were discharged from the hospital at or before day 5 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 being further analyzed, however, preliminary results demonstrated that the IgG level increase was associated with enhanced neutralization activity.

The Company’s IgG product demonstrated a favorable safety profile, and there were no infusion-related reactions or adverse events considered related to study drug. There were two serious adverse events in the study, both were considered not related to the study drug. One patient died on day 37 post-treatment due to complications from COVID-19. Another 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, and was subsequently discharged from the hospital.

In January 2021, the Israeli Ministry of Health (IMOH) initiated a multi-center clinical study of Kamada's COVID-19 IgG product. The study is enrolling hospitalized patients with moderate to severe COVID-19 illness. Enrolled patients are randomized 1:1 to receive either 4 grams of Kamada's IgG product or two units of convalescent plasma. Planned follow-up is 14 days. To date more than 100 patients were enrolled into this study. The lead study investigator is Dr. Yasmin Maor, Head of the Infectious Disease Unit at the Wolfson Medical Center.

“We believe the top-line results of our Phase 1/2 study are indicative of the potential of our plasma-derived IgG product to be a safe and effective treatment for hospitalized COVID-19 patients,” said Amir London, Kamada’s Chief Executive Officer. "Along with our partner, Kedrion Biopharma, we will evaluate the results of the ongoing multi-center clinical study being conducted by the IMOH, which are expected later in 2021, in order to determine the next steps with respect to our COVID-19 IgG clinical development program. In the interim, under our existing agreement, we continue to supply the product to the IMOH for the treatment of COVID-19 patients in Israel.”

The initial order from the IMOH for the product is sufficient to treat approximately 500 hospitalized patients and is expected to generate approximately $3.4 million in revenue for Kamada. The therapy is available nationwide in Israel and patients are being treated as part of the IMOH's clinical study, or on a named-patient basis. The Company is accelerating the manufacturing of the product by utilizing plasma collected in the U.S. by Kedrion. This scaled up manufacturing, at Kamada's commercial scale production line, will support potential expansion of the IMOH supply agreement and possible demand from additional international markets.

Plasma-derived polyclonal IgG products, such as the one developed by Kamada, are considered to have multiple advantages over convalescent plasma transfusion, such as standardized antibody levels, higher potency with better consistency, and higher antibody repertoire; potentially including antibodies for different virus variants due to the plasma being pooled from multiple donors who were infected in different regions. Other comparative benefits of plasma-derived polyclonal IgG products include extensive viral inactivation processing, the absence of a blood-type matching requirement, smaller infusion volumes, the ability to be produced in large quantities, an expected longer shelf life, and preferred storage conditions.

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