CytoDyn sees coronavirus patients in emergency IND program treated with leronlimab make ‘remarkable recoveries’

CytoDyn Inc (OTCQB:CYDY) said Thursday that a majority of coronavirus (COVID-19) patients who were being treated with its flagship drug candidate leronlimab under the US Food and Drug Administration’s (FDA) emergency Investigational New Drug (eIND) program demonstrated “remarkable recoveries.” In a statement, Dr Bruce Patterson, the CEO of CytoDyn’s diagnostic partner and advisor IncellDX, said the company was “very excited” to see the positive results. READ: CytoDyn Inc’s first patient treated with flagship drug leronlimab in Phase 2b/3 trial for coronavirus “We are excited that patients are responding extremely well to leronlimab as expected from the novel mechanism of COVID-19 pathogenesis we discovered and will be reporting in the coming days,” he added. The company broke down the results as follows: Eleven patients in a New York hospital: All the treated patients were in ICU because of acute respiratory failure, eight of whom were put on ventilators. One patient was not intubated because of poor baseline pulmonary status (history of lung cancer and had undergone bilateral upper lobectomy). Seven patients were organ-transplant recipients (six patients were renal-transplant recipients and one patient had a history of heart transplant) and were on immunosuppressive regimen. Ten patients were on dialysis and nine were on vasopressors during hospitalization. Despite their pre-existing and severe conditions, CytoDyn said it believes they “were able to save the lives of four patients.” All patient blood samples were evaluated and "important powerful results from the effect of leronlimab" were demonstrated in almost all these patients, it added. The data has been submitted to a prestigious medical journal and is expected to be published on May 1. Twenty-three patients in Southern California hospital: Six patients were in critical condition and 17 patients were severely ill, needing oxygen support. No deaths were reported. Out of the 6 critical patients, all were intubated patients; 3 were extubated (taken off ventilator), 2 patients remain relatively stable and still breathing with the assistance of a ventilator, and one patient has shown deterioration in respiratory parameters, said the company. Out of 17 severe, but not critical patients, 11 demonstrated improvement in respiratory parameters (8 of them were discharged from hospital), 2 patients remain relatively stable, 2 have shown deterioration in respiratory parameters and information is pending for 2 recently treated patients. Three patients in Georgia hospital: All three ICU patients were intubated and two of them had renal failure at the start of the leronlimab treatment. Of these three patients, two were taken off ventilators and one patient remains on a ventilator but is improving. Meanwhile, the company said that one patient in another New York hospital was taken off oxygen and discharged after being treated with leronlimab, while another patient in Northern California is now being “weaned off the ventilator” and transferred to a rehabilitation hospital. There are updates pending for 10 other patients. In another positive, the group said the US Food & Drug Administration (FDA) has approved five more patients to be eligible for leronlimab under the emergency IND program taking the total number of approvals to 54. CytoDyn CEO Nader Pourhassan said that the results, although anecdotal, are “very impressive” and the number of patients treated under emergency IND is "rapidly increasing." “The enrollment for our Phase 2 double-blind and Phase 2b/3 trials is moving along rapidly, and we believe the results from both studies will be very powerful due to the mechanism of action (MOA) affecting the viral load and restoring the immune system,”  Dr Pourhassan added. “With our first major paper very close to publication, we expect to have a second paper published shortly thereafter, as our MOA is as unique as our results,” he said. Contact the author Uttara Choudhury at uttara@proactiveinvestors.com Follow her on Twitter: @UttaraProactive