Big Rock Partners Acquisition Corp. (NASDAQ:BRPA) shares rose Wednesday trading.
NeuroRx, which has signed an agreement to complete a business combination with Big Rock Partners Acquisition, said Tuesday ZYESAMI has successfully demonstrated 10-day accelerated recovery from respiratory failure in critically ill patients with COVID-19 treated with high flow nasal oxygen at 28-day interim endpoint.
The clinical trial was originally approved as a 28-day study at Food and Drug Administration's direction. In December, NeuroRx added a 60-day endpoint based on the recognition that the traditional 28-day endpoint adopted in the 1990s for trials in Acute Respiratory Distress Syndrome is not appropriate for critically ill patients with COVID-19, who are frequently maintained in the ICU with advanced technologies well beyond this time point. NeuroRx and other clinical trial sponsors alerted FDA to this trend.
Yesterday, the FDA published formal guidance changing the required time for measuring the pre-specified endpoint of "alive and free of respiratory failure" in critically ill patients to 60 days.
At 28 days, patients treated with ZYESAMI™ demonstrate 35% higher likelihood of recovery from respiratory failure with continued survival compared to patients treated with placebo. In tertiary care hospitals, ZYESAMI-treated patients were 46% more likely to recover and return home before day 28.
BRPA shares galloped $6.29, or 14.4%, to $49.90.
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