Kamada (NASDAQ:KMDA) jumps 17% premarket in reaction to completing enrollment and announcing initial interim results from its ongoing Phase 1/2 open-label trial in Israel of its anti-SARS-CoV-2 plasma-derived hyperimmune immunoglobulin (IgG) product as a potential treatment for 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. Patient follow-up will occur for 84 days.
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.
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.
“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, CEO.
FDA response on submitted pre-IND information package expected next Month; U.S. clinical development anticipated to commence in early 2021.
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