CytoDyn to wrap up leronlimab coronavirus trial enrolment this month; asking FDA to expand access to patients who don't qualify

CytoDyn Inc (OTCQB:CYDY) has told investors that it expects to complete enrollment for Phase 2 trials of its leronlimab drug as a potential coronavirus treatment by the end of May. The company is conducting a pair of medical trials of its drug, one for coronavirus patients with mild-to-moderate symptoms and another for patients with severe symptoms. The double-blinded, placebo-controlled trials involve 75 patients. CytoDyn also said, it has submitted an additional request to the US Food and Drug Administration (FDA) for expanded access, known as compassionate use, that would make leronlimab available to patients who do not qualify for the clinical trial. Many severely ill coronavirus patients who have received off-label treatments were excluded from the trials but could potentially benefit from using leronlimab through compassionate use, it said. READ: CytoDyn sees coronavirus patients in emergency IND program treated with leronlimab make ‘remarkable recoveries’ The group pointed out that 49 coronavirus patients enrolled for treatment through an Emergency Investigational New Drug (eIND) application granted to the company by the FDA. Four of the 11 critically ill patients with a multitude of pre-existing conditions survived after treatment, the company noted. Of the next 38 other patients, many were extubated, improved or were discharged, CytoDyn added. “We are very excited about the continuing positive responses from eIND patients following their treatment with leronlimab,” CytoDyn CEO Nader Pourhassan said in a statement. “We are equally excited about the prospects for patients should the FDA grant access to leronlimab under the compassionate use program.” Pourhassan noted that he has already encountered patients who want to try CytoDyn’s drug. “During this past Saturday, we had to overcome many obstacles for two patients who desperately wanted leronlimab,” Pourhassan said. “One patient was in the same hospital that enrolled the first 11 patients and the second was a VIP patient in Los Angeles. Under the compassionate use program, we could avoid and quickly overcome this type of stress and turmoil which was very difficult for the patients, their families, the physicians and CytoDyn.” Others, he said, have already seen its benefits: “The daughter of a patient who was on a machine used for severe heart and lung failure contacted us directly and expressed her immense gratitude believing leronlimab saved her mother’s life. These are amazing times for us at CytoDyn; with the opportunity to wake up every day with the potential of saving somebody’s life. For sure, I could never have imagined such an incredible honor.” In addition to its potential as a treatment for the coronavirus, leronlimab has other therapeutic indications as a treatment for metastatic triple-negative breast cancer, immunologic diseases such as graft-versus-host disease and NASH. Contact Andrew Kessel at andrew.kessel@proactiveinvestors.com  Follow him on Twitter @andrew_kessel