Phase II Trial of Leronlimab for COVID-19 Enrolls First Patients

CytoDyn announced that it has enrolled and treated the first 2 patients with coronavirus disease 2019 (COVID-19) with leronlimab (PRO 140) – a treatment in the pipeline as a treatment for patients with triple-negative breast cancer (TNBC) – under its phase II randomized clinical trial, which is specifically for those with mild-to-moderate indications.¹

The phase II clinical trial is a randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of leronlimab and calls for 75 planned patients in up to 10 centers in the US.²

Additionally, leronlimab has now been administered to 15 severely ill patients with COVID-19 at 4 hospitals, with 10 patients being treated at a leading medical center in the New York City area and 5 patients at 3 other hospitals. The patients were all able to be administered the agent under an emergency investigational new drug (EIND), which were granted by the FDA for each individual patient. 

“We are encouraged by the positive results demonstrated with leronlimab in the New York patients,” Bruce Patterson, MD, chief executive officer and founder of IncellDx, a diagnostic partner and advisor to CytoDyn, said in a press release. “Our team is working hard to distribute leronlimab to multiple clinical sites to initiate therapy in patients with severe COVID-19 disease. While every patient is experiencing different comorbidities, we are seeing similar clinical responses, which we believe is a reflection of leronlimab’s mechanism of action.”

The company also indicated that they anticipate initiating their other COVID-19 trial this week. The phase IIb/III trial is for severely ill patients with COVID-19 and is anticipated to enroll 342 patients.

The trial will be double blinded with a 2:1 ratio of drug to placebo. Moreover, the participants are expected to be administered leronlimab for 2 weeks, with the primary endpoint being the mortality rate at 14 days. The company will then perform an interim analysis on the data from 50 patients following the 2 weeks of leronlimab therapy.

“Our partnership with the New York medical team and now other hospitals has been exemplary. We are collaborating in every aspect to deliver leronlimab to patients in order to provide proof of concept as soon as possible,” Nader Pourhassan, PhD, president and chief executive officer of CytoDyn, said in a press release. “We are very hopeful of sending the day three and day seven results of the first ten EIND patients to the FDA by the end of this week.”

As of now, the FDA has granted fast track designation for 2 potential indications of leronlimab for deadly diseases. The first as a combination therapy with HAART for HIV-infected patients, and the second for metastatic TNBC. Additionally, the FDA has granted “orphan drug” designation to leronlimab for the prevention of graft-versus-host disease (GvHD).

Further, leronlimab was found to reduce human breast cancer metastasis by more than 98% in a murine xenograft model. CytoDyn is therefore conducting a phase Ib/II human clinical trial of the agent in metastatic TNBC based on this finding.

Leronlimab has completed 9 clinical trials thus far in over 800 people, including meeting its primary endpoint in a pivotal phase III trial of leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients. The investigational humanized IgG4 mAb blocks CCR5, a cellular receptor that is important in HIV infection, tumor metastases, and other diseases, including NASH. 

References:

1. First Two Patients Enrolled in Randomized Phase 2, COVID-19 Trial with Leronlimab; Five More Severely Ill COVID-19 Patients Treated Under Emergency IND and Two Patients Have Already Extubated [news release]. Vancouver, Washington. Published April 6, 2020. cytodyn.com/newsroom/press-releases/detail/409/first-two-patients-enrolled-in-randomized-phase-2-covid-19. Accessed April 8, 2020. 

2. CytoDyn Enrolls First Two Patients in Phase 2 COVID-19 Trial With Leronlimab [news release]. Published April 6, 2020. nasdaq.com/articles/cytodyn-enrolls-first-two-patients-in-phase-2-covid-19-trial-with-leronlimab-2020-04-06. Accessed April 8, 2020.