Blood samples from <a>days 0, 3, and 7</a> demonstrated that leronlimab induced significant reductions in the cytokine storm among all 7 severely ill patients with coronavirus disease 2019 under evaluation in the phase IIb/III study. The blood samples confirmed immunological benefit at day 3 and 7 in all patients, according to a press release from CytoDyn, Inc.
Blood samples fromdays 0, 3, and 7demonstrated that leronlimab induced significant reductions in the cytokine storm among all 7 severely ill patients with coronavirus disease 2019 (COVID-19) under evaluation in the phase IIb/III study. The blood samples confirmed immunological benefit at day 3 and 7 in all patients, according to a press release from CytoDyn, Inc.1
“The day 7 results from these patients demonstrates even more dramatic immune restoration especially in the CD8 T-lymphocyte population, the major immune cell responsible for eliminating virally infected cells,” Bruce Patterson, MD, chief executive office, founder, IncellDx, stated in a press release. “In addition, there is a further dramatic reduction in the critical cytokine storm cytokines IL-6, TNF-alpha.”
On March 31, 2020, the FDA provided clearance for theimmediate enrollment and initiation of the phase II trial evaluating leronlimab in patients with COVID-19and mild to moderate respiratory complications, according to a press release from CytoDyn. In addition, an emergency Investigational New Drug (IND) application, filed by CytoDyn, was cleared by the FDA to allow for immediate treatment of leronlimab to 2 patients with severe COVID-19 in New York.
CytoDyn also announced positive findings from 1 patient with severe COVID-19 who was treated with leronlimab at the Southern California Medical Center. The patient was in critical condition in the ICU and received an IL-6 blocking agent, but the patient did not show any evidence of benefit within 4 days. At the same time, the patient received either an antiretroviral agent or placebo in an unrelated clinical trial.2
Leronlimab was given to the patient under an emergency IND granted by the FDA, and within 24 hours, the patient had significant clinical improvement with leronlimab. The patient was removed from external ventilation 3 days after receiving the injection of leronlimab. These findings remain consistent with other observations of leronlimab in patients with severe COVID-19 from a leading medical center in New York City, New York.
Two additional patients with moderate COVID-19 were treated at the Southern California Medical Center with leronlimab under an emergency IND and demonstrated clinical improvement as well. Patients were removed from external oxygen support 1 day after treatment with leronlimab and discharged from the hospital.
Four additional patients with moderate COVID-19 have received leronlimab based on these findings, and the results are pending.
The company is enrolling patients to 2 clinical trials, including a phase II trial for patients with mild to moderate COVID-19 and a phase IIb/III trial for severely and critically ill patients with COVID-19, following clearance from the FDA.1
The double-blinded phase IIb/III clinical trial will enroll 390 patients. Patients are randomized 2:1 to receive either leronlimab or placebo. Leronlimab will be administered for 2 weeks. The primary end point is mortality rate at 28 days, and a secondary end point is the mortality rate at 14 days. An interim analysis is expected to be performed on data from 50 patients.
Leronlimab has been previously granted a Fast Track designation for 2 potential indications. The first indication is for the combination of leronlimab with HAART for the treatment of HIV-infected patients, and the second isas treatment of patients with metastatic triple-negative breast cancer.
The CCR5 antagonist has completed 9 clinical trials in more than 800 patients. In studies of patients with cancer, research has demonstrated that blocking CCR5 can reduce tumor metastases in both laboratory and animal models of breast and prostate cancer. Human breast cancer metastasis was reduced by over 98% with leronlimab in a murine xenograft model.
Other clinical trials have also demonstrated that blocking CCR5 can reduce the impact of acute graft-versus-host-disease (GVHD) without significantly affecting the engraftment of transplanted bone marrow stem cells. The company is conducting a phase II clinical trial to support this concept, and the FDA granted an Orphan Drug designation to leronlimab for the prevention of GVHD.
“We are very pleased that leronlimab appears to facilitate an immunological restoration in these patients and we are sharing our data with the FDA in order to hopefully accelerate the access of our drug to many more patients in need,” Nader Pourhassan, PhD, president and chief executive officer, CytoDyn, said in a statement. “With more than 20 EINDs approved by the FDA, we are receiving an overwhelming number of EIND requests from all over the country.”