CytoDyn to File Accelerated Rolling Review with MHRA and Interim Order (IO) with Health Canada for COVID-19 - Seite 2
2) Statistically significant results (p-value = 0.0552) reported for the primary endpoint (all-cause mortality at Day 28) among participants who received dexamethasone as the prior or concomitant standard of care treatment (“SoC”) for COVID-19, compared to patients who received dexamethasone (without leronlimab) as SoC therapy in the overall mITT population.
3) Amongst all patients in mITT, the primary endpoint (all-cause mortality at Day 28) was not statistically significant. When age adjustment was conducted, the primary endpoint was much closer to statistically significant value. Of note, the reduction of mortality in this population of 65 years and younger leronlimab arm had more than 30% less mortality than placebo and 9% less mortality in participants over 65.
With the age adjustment analysis in all other major secondary endpoints, there was consistent numerical superiority over the placebo group, with some secondary endpoints approaching statistical significance.
Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn, commented, “We are grateful for the chance to help critically ill COVID-19 patients. We continue to be pleased with the results from over 80 EINDs, 394 patients in CD12, and another 46 patients in the continuation of CD12’s open-arm access, as well as the results published in two different peer reviewed journals. I am humbled by comments from the families whose lives they believe were saved with leronlimab and we look forward to making leronlimab more readily available to treat patients with COVID-19 and many other indications we are working on. I’m excited to address our investment community on Monday and to congratulate our entire extended team for their tireless support of the leronlimab program.”
About Leronlimab (PRO 140)
The FDA has granted a Fast Track designation to CytoDyn for two potential indications of leronlimab for critical illnesses. The first indication is a combination therapy with HAART for HIV-infected patients and the second is for metastatic triple-negative breast cancer. Leronlimab is an investigational humanized IgG4 mAb that blocks CCR5, a cellular receptor that is important in HIV infection, tumor metastases, and other diseases, including NASH. Leronlimab has completed 11 clinical trials in over 1,200 people and met its primary endpoints in a pivotal Phase 3 trial (leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients).