Phase III trial for leronlimab in COVID-19 patients disappoints

9 March 2021
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USA and Canada-based biotech CytoDyn (OTC.QB: CYDY), which is developing Vyrologix (leronlimab-PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, yesterday reported the Phase III trial of leronlimab for the treatment of severe-to-critical patients with COVID-19.

Despite the company putting a positive spin on the data, saying continued safety, substantial improvement in the survival rate, and faster hospital discharge in critically ill COVID-19 patients had been demonstrated, investors did not buy it, and CytDyn saw its shares tank 28% to $2.91 by close of trading.

The trial’s data has been reported to the US Food and Drug Administration, the UK’s Medicines & Healthcare product Regulatory Agency (MHRA) and Health Canada, and the Company is in discussions with each to determine the best path forward for approval of leronlimab for treatment of COVID-19 in critically ill population. A manuscript of the trial’s data is being prepared and will be submitted for publication in one or more major medical journals.

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