VANCOUVER, Wash.—CytoDyn Inc., a late-stage biotechnology company developing CCR5 antagonist leronlimab (PRO 140) for multiple therapeutic indications, announced July 21 the results of the patient safety data from the company’s over-enrolled COVID-19 Phase 2 trial for mild-to-moderate indications.
A total of 84 patients were treated across eight study sites in the randomized, double-blind, placebo-controlled Phase 2 study. Fifty-six patients were assigned to the leronlimab arm compared to 28 patients in the randomized placebo arm. This trial was designed to evaluate the safety and efficacy of leronlimab, though the results of efficacy portion are yet to be released given that the statistical analyses of all primary and secondary endpoints are ongoing.
In this study, 34 percent of patients treated with leronlimab reported at least one adverse event, compared to 50 percent treated with placebo. A total of 19 serious adverse events (SAEs) were reported during the study. Eleven SAEs were reported in six patients receiving placebo, compared to eight SAEs in five patients receiving leronlimab. None of the SAEs in the leronlimab arm were deemed related to study drug administration by the investigators. Of the 84 patients treated, one patient died 33 days after enrollment due to an event unrelated to leronlimab.
“We are very pleased with the safety results in the double-blinded, placebo-controlled study of the mild-to-moderate COVID-19 population. When considering treatment options in the COVID-19 population, it is paramount in treating this complex disease to provide patients with therapeutic options that minimize SAEs,” said Dr. Scott Kelly, CytoDyn’s chief medical officer. “We believe the significant reduction in SAEs in the leronlimab group ultimately translates into improved patient clinical outcomes. Prior drugs in clinical trials for the treatment of COVID-19 have resulted in an increase in SAEs in the drug treated arm vs. placebo. We are extremely proud of these results.“
Added Dr. Jacob Lalezari, senior science advisor to CytoDyn: “We are delighted to see a clinically meaningful reduction in SAEs in the mild-moderate COVID-19 population. Leronlimab has been extremely well tolerated in prior clinical trials in over 750 HIV-positive patients. These new safety data are therefore consistent with our prior experience and very encouraging in the COVID-19 population. The once-a-week subcutaneous administration of leronlimab is also convenient for patients and caregivers alike. We eagerly anticipate the results of the full efficacy analysis and hope to soon provide the world a broadly effective therapeutic option for this devastating pandemic.”
The FDA has granted a Fast Track designation to CytoDyn for two potential indications of leronlimab for deadly diseases—the first as 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. Leronlimab has completed nine clinical trials in more than 800 people, including meeting its primary endpoints in a pivotal Phase 3 trial (leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients).
“We are very pleased to see clear advantages for the patients in this population in leronlimab versus placebo in regards to SAEs and look forward to announcing all of the efficacy endpoints very soon,” said Dr. Nader Pourhassan, president and CEO of CytoDyn. “We are equally optimistic and look forward to the data safety monitoring committee’s upcoming review of the progress of our Phase 3 trial for COVID-19 patients with severe and critical indications and remain hopeful the therapeutic benefits for this patient cohort will be consistent with the results we saw from the administration of leronlimab to over 60 patients under eIND authorizations previously granted by the U.S. Food and Drug Administration.”