The first severe and critically ill patient with coronavirus disease 2019 has been treated with leronlimab in a phase IIb/III clinical trial, announced CytoDyn Inc., developer of the drug. A total of 15 patients have also been enrolled to the phase II trial of patients with mild to moderate COVID-19.
The first severe and critically ill patient with coronavirus disease 2019 (COVID-19) has been treated with leronlimab in a phase IIb/III clinical trial, announced CytoDyn Inc., developer of the drug. A total of 15 patients have also been enrolled to the phase II trial of patients with mild to moderate COVID-19.1
“We are very excited to start our Phase2b/3 trial in patients with severe COVID-19. Based on the promising results from the EIND patients, we are hopeful that this randomized, placebo-controlled trial will give us the data needed for FDA approval and ultimately the basis to use leronlimab to save lives in this pandemic,” Bruce Patterson, MD, chief executive officer, founder, IncellDx, and advisor to CytoDyn, said in a statement.
The company also announced that about 30 patients have received leronlimab under the Emergency Investigational New Drug authorizations granted by the FDA.
The FDA granted clearance forthe initiation and enrollment of the clinical trial for severe and critically ill patients with COVID-19. Investigators aim to enroll 390 patients, who will be randomized 2:1 to receive either leronlimab or placebo.
Leronlimab, a CCR5 antagonist, will be administered for 2 weeks in this trial. The primary end point of the study is the mortality rate at 28 days, and a secondary end point is the mortality rate at 14 days. An interim analysis will be performed on the first 50 patients.
This agent has been granted a Fast Track designation from the FDA for 2 potential indications of COVID-19. Overall, leronlimab has been evaluated in 9 clinical trials in more than 800 patients and has met its primary end points in a pivotal phase III trial of patients with HIV-infected patients in combination with standard antiretroviral therapies.
In the cancer setting, CCR5 plays a potential role in tumor invasion, metastases, and tumor microenvironment control. Increased expression of CCR5 may indicate disease status in several cancers, and several published studies have indicated that blocking CCR5 may reduce tumor metastases in laboratory and animal models of aggressive breast cancer and prostate cancer.
The first patient with breast cancer has been treated with leronlimab in a phase II basket trial for 22 solid tumors, according to another update from CytoDyn. The study aims to evaluate leronlimab in approximately 22 solid tumors, such as melanoma, glioblastoma, throat, lung, stomach, colorectal, breast, testicular, ovarian, uterine, pancreatic, and bladder cancers, among others.2
Investigators plan to enroll 30 patients with CCR5-positive locally advanced or metastatic solid tumors. Patients will receive a subcutaneous dose of leronlimab at 350 mg. The trial is being conducted at several institutions across the United States. Preliminary data are expected within 3 to 4 weeks of the initial injection for each patient. The primary end point is progression-free survival.
“We continue to support the medical community’s increasing demand for leronlimab and are pleased for the severely ill patients now enrolling in our Phase 2b/3 trial,” said Nader Pourhassan, PhD, president and chief executive officer, CytoDyn, said in a statement.1“We are hopeful that they will experience like therapeutic benefits demonstrated by many similar patients treated under EINDs. We are humbled by the dedication and courage exhibited by our medical professionals every day in their tireless efforts to combat this horrific pandemic.”