FDA Approves Octapharma Investigational New Drug Application

On May 20, 2020

The U.S. Food and Drug Administration (FDA) has approved the investigational new drug (IND) application submitted by Paramus-based Octapharma USA for a phase three clinical trial on the efficacy and safety of Octagam^® 10% [Immune Globulin Intravenous (Human)] therapy in COVID-19 patients with severe disease progression.

The primary objective of the randomized, double-blind, placebo-controlled, multicenter study is to determine if high-dose Octagam^® 10% therapy will slow or stop respiratory deterioration in patients with severe coronavirus disease. The secondary objectives of the study are to measure the effects of a high-dose of Octagam^® 10% on slowing or stopping the clinical progression of COVID-19 by improving pulmonary function, quality of life, and correlated impact on metabolic factors.

“Although many therapies based on provisional data have been proposed for patients who suffer from COVID-19, known treatments are limited,” said Octapharma USA President Flemming Nielsen. “Intravenous immunoglobulin (IVIG), which consists of pooled IgG preparations from thousands of donors, has been used to treat patients with immune-mediated diseases for almost 40 years.  Our hypothesis is that the use of IVIG in the prophylaxis of severe infections, especially in immunocompromised patients, makes it an attractive therapeutic possibility for COVID-19.”

The study will begin immediately at approximately 10 U.S. research sites with the goal of enrolling about 54 adult patients diagnosed with COVID-19 with a resting SpO2 of ≤93%, requiring oxygen supplementation. SpO2, also known as oxygen saturation, is a measure of the amount of oxygen-carrying hemoglobin in the blood relative to the amount of hemoglobin not carrying oxygen.

Patients in the trial will be randomized to receive either Octagam^® 10% or a placebo, and will be monitored for approximately 33 days. Those receiving Octagam^® 10% will be administered a total dose of 2 g/kg as an intravenous infusion of 0.5 g/kg over a two-hour period daily for four consecutive days. Octapharma hopes to report study results by the third quarter of 2020.

“Several case reports on utilizing IVIG treatment for COVID-19 patients have shown  positive results,” said Wolfgang Frenzel, M.D., head of research & development at Octapharma. “The effects of the immune-modulating properties of IVIG in severely-ill COVID-19 patients appeared to be demonstrated in the case reports and we are, therefore, hopeful that we will observe improved clinical status in the patients receiving Octagam^® 10%.”

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