CytoDyn Collaborates with UK’s Department of Health to Provide Emergency Access to Leronlimab (PRO 140) for Patients with COVID-19

Shots:

• CytoDyn is collaborating with the UK’s Department of Health to provide emergency access to its investigational therapy, leronlimab to treat patients with COVID-19. The MHRA’s submission is expected to be made soon to include clinical sites in the UK
• The US FDA has approved the initiation of its P-IIb/III clinical study for severe and critically ill COVID-19 patients for which enrollment is in progress.  The P-IIb/III study will assess leronlimab (q2w) vs PBO in 390 patients in a ratio 2:1 with its 1EPs as mortality rate @28days and 2EPs as mortality rate @14days
• CytoDyn has initiated enrollment in a P-II clinical study for mild-to-moderate COVID-19 patients in the US. Leronlimab is an IgG4 mAb that blocks CCR5 and has received the US FDA’s FT designation as a combination therapy with HAART for HIV infected patients and for metastatic triple-negative BC

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