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Sept. 18, 2021

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FDA says CytoDyn drug didn’t aid COVID cases

By , Columbian business reporter
Published:

Shares of Vancouver-based biotech company CytoDyn fell sharply last week after the U.S. Food and Drug Administration released a statement saying that the company’s signature product in development — an antibody called leronlimab — had not shown a significant benefit in either of two clinical trails intended to gauge the drug’s effectiveness as a treatment for COVID-19.

CytoDyn is developing leronlimab as a potential HIV treatment, but the company has also sought to test it for several other potential applications, most recently as a COVID-19 treatment. The company had theorized that the drug could work as an anti-inflammatory agent that could aid COVID-19 patients exhibiting acute respiratory distress.

The FDA claimed that CytoDyn publicly communicated results from small subgroups of one trial’s participants, “suggesting that the data demonstrated a mortality benefit in certain patients who had received leronlimab,” but that the results did not show a benefit in the overall study population. The study data “illustrated imbalances in mortality among subgroups, some favoring leronlimab and some favoring placebo,” the FDA wrote.

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