CytoDyn says FDA resumes eIND approval of leronlimab for severe-to-critical COVID-19 patients

CytoDyn Inc (OTCQB:CYDY) revealed on Tuesday that a treating physician has received authorization from the US Food and Drug Administration (FDA) to administer Vyrologix (leronlimab) for a coronavirus (COVID-19) patient under the FDA’s emergency Investigational New Drug (eIND) program.  In a statement, CytoDyn CEO Nader Pourhassan said: “We are very thankful the FDA is allowing severe-to-critical COVID-19 patients access to Vyrologix (leronlimab) again under eIND while we await the unblinding of data from our recently completed Phase 3 registrational trial.” “We are receiving daily requests from families seeking our drug for a loved one with COVID-19. In recent months, leronlimab received more than 60 eIND authorizations from the FDA, and during the pendency of our COVID-19 trials, we deferred seeking authorizations for eINDs in order to accelerate the pace of enrollment.” READ: CytoDyn completes full enrollment in its Phase 3 registrational trial for severe-to-critical COVID-19 patients The CytoDyn boss said that now that enrollment has been completed, the company is “pleased to be able to assist once again” and remains hopeful the upcoming results of its Phase 3 trial will “enable leronlimab to be more readily available for severe-to-critical COVID-19 patients.” Vancouver, Washington-based CytoDyn’s Phase 2b/3 trial to evaluate the effectiveness and safety of leronlimab for patients with severe-to-critical COVID-19 indications is a two-arm, randomized, double-blind, placebo-controlled, adaptive design multicenter study. Patients are randomized to receive weekly doses of 700 mg leronlimab, or placebo. Leronlimab and placebo are administered through injections. The primary outcome measured in this study is linked to mortality at Day 28. There are secondary outcomes measured by mortality at Day 14, change in clinical status of the subject at Day 14, change in clinical status of the subject at Day 28, and change from baseline in Sequential Organ Failure Assessment (SOFA) score at Day 14. CytoDyn completed its Phase 2 clinical trial for COVID-19, a double-blinded, clinical trial for mild-to-moderate patients in the US which produced statistically significant results for NEWS2. Significantly, CytoDyn completed enrollment of 390 patients in its Phase 2b/3 clinical trial for the severe-to-critically ill COVID-19 population. All eyes are now on results, which are expected in mid-January 2021. The FDA has granted Fast Track designation to CytoDyn for two potential indications of leronlimab for critical illnesses. The first is a combination therapy with HAART for HIV-infected patients and the second is for metastatic triple-negative breast cancer. Contact the author Uttara Choudhury at uttara@proactiveinvestors.com Follow her on Twitter: @UttaraProactive