CytoDyn to add open-label extension to its Phase 3 trial of leronlimab for severe-to-critical COVID-19 patients

CytoDyn Inc (OTCQB:CYDY) revealed on Thursday that the US Food and Drug Administration (FDA) has issued guidance to add an open-label extension to its Phase 3 trial (CD12) for Vyrologix (leronlimab-PRO 140) in severe-to-critically ill COVID-19 patients, including specific criteria for the continuation of eINDs for patients meeting the inclusion/exclusion criteria of CD12. The Vancouver, Washington-based late-stage biotechnology company expects to amend the trial protocol and seek FDA submission on December 28. Upon regulatory clearance, the trial sites will have the option of enrolling additional qualified patients who will undergo the treatment until the trial’s data is unblinded. READ: CytoDyn says FDA resumes eIND approval of leronlimab for severe-to-critical COVID-19 patients CytoDyn said the FDA also provided specific guidance for the benefit of physicians seeking an emergency Investigational New Drug (eIND) for COVID-19 patients, which must first meet the inclusion/exclusion criteria of the CD12 study. The company said the criteria “will be provided to them in the form of a checklist.” CytoDyn Chief Scientific Officer Mahboob Rahman, who heads clinical development, said: “We are pleased that at a time when COVID-19 cases and mortality continue to increase, the FDA’s thoughtful advice will allow a specified subset of patients access to leronlimab, while we await the results of the randomized placebo-controlled portion of the Phase 3 study.” “We are committed to work with the FDA and the health care providers to improve the outcomes of COVID patients.” Meanwhile, CytoDyn CEO Nader Pourhassan, said the company is “very thankful” to the FDA for providing guidance on accessing leronlimab pending the “results of the CD12, especially during these unprecedented times.” “CytoDyn will provide the precise requirements for potential participation in the new CD12 open-label extension and physicians seeking eINDs, while we eagerly await the unblinding of the data. The results of our CD10 trial will not support an eIND request,” added Pourhassan. 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