CytoDyn files FDA-suggested modifications to IND and protocol for phase II clinical trial for COVID-19 patients with mild to moderate indications .

CytoDyn Inc. developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced that, at the suggestion of the FDA, the Company filed another round of modifications to its IND and protocol for a Phase II clinical trial with leronlimab (PRO 140). In addition, the FDA suggested the Company file a second randomized protocol for all COVID-19 patients in severe condition, so as to preclude each physician from filing an emergency IND for every patient to be treated with leronlimab. The treatment with leronlimab is targeted as a therapy for patients who experience respiratory complications as a result of contracting SARS-CoV-2 causing the Coronavirus Disease 2019 (COVID-19). Leronlimab is believed to provide therapeutic benefit by enhancing the immune response while mitigating the “cytokine storm” that leads to morbidity and mortality in these patients. The first Phase II clinical trial that was filed on March 26 is a randomized, double blind, placebo-controlled study to evaluate the efficacy and safety of leronlimab in patients with mild to moderate documented COVID-19 illness and calls for 75 planned patients in up to 10 centers in the United States. Patients enrolled in the trial are expected to have a treatment window of approximately 6 weeks.