CytoDyn has received approval from Brazil’s Agência Nacional de Vigilância Sanitária (ANVISA) to initiate subject enrolment in a Phase III CD17 clinical trial of leronlimab in patients with severe Covid-19.
Leronlimab is an experimental humanised immunoglobulin G4 monoclonal antibody that targets C-C chemokine receptor type 5 (CCR5).
CCR5 is a cellular receptor vital in HIV infection, tumour metastases, non-alcoholic steatohepatitis and other conditions.
The ANVISA approval for trial protocol comes after CytoDyn’s distribution partner, Biomm, sought authorisation to conduct two Phase III trials of leronlimab for Covid-19.
The Phase III CD17 trial will enrol 612 hospitalised Covid-19 patients who require oxygenation support at up to 35 clinical centres in the country.
Prevention of disease progression and invasive mechanical ventilation requirements will be the trial’s goal.
The trial is expected to offer data required by ANVISA to consider making leronlimab available for Covid-19-infected Brazilians.
CytoDyn anticipates performing an interim analysis on reaching 40% enrolment and when the last recruited subject completes 28 days of therapy with the drug.
Albert Einstein Israelite Hospital (AEIH), a Brazilian academic research organisation will carry out the CD17 trial.
This May, CytoDyn and AEIH signed an agreement to initiate two Phase III trials of leronlimab in patients with severe Covid-19 in São Paulo, Brazil.
CytoDyn chief operating officer and Clinical Development head Chris Recknor said: “The CD17 trial was designed in collaboration with our partners at Einstein ARO and BIOMM to have an adequately powered interim analysis after 40% of the patients have been enrolled and completed 28 days of treatment with leronlimab.
“Given that average weekly cases currently are over 35,000, we anticipate that the results of the interim analysis may be available in the next three to four months using the endpoints we refined from CD12.”
ANVISA is also reviewing a protocol submitted by CytoDyn for another trial in 316 critically ill Covid-19 patients.