Kamada (KMDA)

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Kamada Announces Completion of Enrollment 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 Phase 1/2 Open-Label, Single Arm, Multi-Center Clinical Trial is Testing Kamada’s Hyperimmune IgG Product in Hospitalized, Non-Ventilated COVID-19 Patients with Pneumonia
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 Favorable 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

REHOVOT, Israel, Sept. 08, 2020 (GLOBE NEWSWIRE) -- Kamada Ltd. (NASDAQ & TASE: KMDA), a plasma-derived biopharmaceutical company, today announced the completion of enrollment and initial interim results from its ongoing Phase 1/2 open-label, single-arm, multi-center clinical trial in Israel of the Company’s anti-SARS-CoV-2 plasma-derived hyperimmune immunoglobulin (IgG) product as a potential treatment for coronavirus disease (COVID-19).

The trial is designed to assess the safety, pharmacokinetics, and pharmacodynamics of Kamada’s plasma-derived IgG product in hospitalized, non-ventilated COVID-19 patients with pneumonia. A total of 12 eligible patients (age 34-69) were enrolled in the trial and received the Company’s product at a single dose of 4 grams IgG within five to 10 days of initial symptoms. Patient follow-up will occur for 84 days.

To date, five of the 12 patients have completed 21-day post-treatment follow-up, two patients have completed 14-day post-treatment follow-up and the additional five patients have completed 7-day post-treatment follow-up. Symptoms improvement was observed in 11 of the 12 patients within 24 to 48 hours from treatment. All 11 patients were subsequently discharged from the hospital within a median hospital stay of 4.5 days from treatment.

The medical condition of one patient, who completed the 14-day post-treatment follow-up, deteriorated and this individual is currently on mechanical ventilation. One patient had a serious adverse event four days after treatment, which was categorized by the investigator as unrelated to the Company’s IgG product, that the patient received in the trial.

“The safety profile of our IgG product and symptoms improvement preliminarily demonstrated by these results are favorable and we plan to continue characterizing the virus neutralization activity of the product in order to calibrate the treatment dose,” said Dr. Naveh Tov, Kamada’s VP Clinical Development and Medical Director.

“We expect that these initial interim results, and the final trial results, to be available by January 2021, will support our clinical plan to advance our IgG product as a potential treatment for hospitalized COVID-19 patients,” said Amir London, Kamada’s Chief Executive Officer. “As a reminder, the FDA recently issued an Emergency Use Authorization for convalescent plasma as a potential treatment for COVID–19. Convalescent plasma plays an important role in the immediate and intermediate response to the disease. Plasma-derived IgG product, as developed by Kamada, is considered to have multiple advantages over convalescent plasma transfusion, such as standardized antibody levels, higher potency, 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,” concluded Mr. London.

The Phase 1/2 trial in Israel is being conducted as part of Kamada’s global collaboration with Kedrion Biopharma, established in April 2020, for the development, manufacturing, and distribution of a plasma-derived IgG product as a potential treatment for COVID-19. With Kedrion’s support, Kamada submitted a pre-Investigational New Drug (IND) information package to the U.S. FDA, with its proposed U.S clinical development plan, FDA’s response is expected next month.

https://finance.yahoo.com/news/kamada-announces-completion-enrollment-initial-110000215.html